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The Agency for Healthcare Research and Quality (AHRQ), formerly the Agency for Health Care Policy and Research, through its Evidence-based Practice Centers (EPCs), sponsors the development of evidence reports and technology assessments to assist public- and private-sector organizations in their efforts to improve the quality of health care in the United States. The reports and assessments provide organizations with comprehensive, science-based information on common, costly medical conditions and new health care technologies. The EPCs systematically review the relevant scientific literature on topics assigned to them by AHRQ and conduct additional analyses when appropriate prior to developing their reports and assessments.
To bring the broadest range of experts into the development of evidence reports and health technology assessments, AHRQ encourages the EPCs to form partnerships and enter into collaborations with other medical and research organizations. The EPCs work with these partner organizations to ensure that the evidence reports and technology assessments they produce will become building blocks for health care quality improvement projects throughout the Nation. The reports undergo peer review prior to their release.
AHRQ expects that the EPC evidence reports and technology assessments will inform individual health plans, providers, and purchasers as well as the health care system as a whole by providing important information to help improve health care quality.
We welcome written comments on this evidence report. They may be sent to: Director, Center for Practice and Technology Assessment, Agency for Healthcare Research and Quality, 6010 Executive Blvd., Suite 300, Rockville, MD 20852.
| John M. Eisenberg, M.D. | Director, Center for Practice and |
| Director | Technology Assessment |
| Agency for Healthcare Research and Quality | Agency for Healthcare Research and Quality |
| The authors of this report are responsible for its content. Statements in the report should not be construed as endorsement by the Agency for Healthcare Research and Quality or the U.S. Department of Health and Human Services of a particular drug, device, test, treatment, or other clinical service. |
Surgery for age-related cataract is the highest volume surgical procedure in the Medicare population. In the United States, approximately 1.5 million cataract operations were performed on Medicare beneficiaries in 1996. Cataract surgery is almost exclusively performed as an outpatient procedure and usually involves the administration of a local anesthetic in addition to systemic sedation administered by an anesthesiologist or nurse anesthetist. There is considerable national and international variation in anesthesia management strategies for cataract surgery. The principal objectives of this Evidence Report are to summarize the published literature on (1) the risks and benefits associated with the use of one form of regional anesthesia over another and (2) the risks and benefits associated with different approaches to sedating the patient for cataract surgery.
The primary sources for the literature review were PubMed and the Cochrane Collaboration's database of controlled clinical trials. Medical subject heading (MeSH) terms used in the searches included cataract, anesthesia, and hypnotics or sedatives. All included studies were published between 1968 and 1999.
An article was included in the Evidence Report if it (1) addressed cataract surgery using local anesthesia (with or without sedation) in an adult population, (2) was a controlled trial or a case series with more than 100 cases, and (3) provided outcomes specifically related to the research questions.
After assessment of 739 potentially relevant citations, by abstract or full manuscript review, 141 were identified that met eligibility criteria. Study quality was assessed and data abstracted by pairs of reviewers. Results are presented in evidence tables and the quality of evidence for specific questions graded as strong, moderate, weak, or insufficient. Supplemental analyses include a decision analysis comparing alternative management strategies, an analysis of early postoperative morbidity and mortality based on Medicare claims data, and an analysis of patient perceptions of different anesthesia strategies from the Study of Medical Testing for Cataract Surgery.
Of the 141 reviewed studies, 122 focused on local anesthesia techniques either alone or in combination with sedation strategies. Of these, 86 were randomized clinical trials and 36 were noncontrolled studies. Nineteen studies, all of which were randomized clinical trials, specifically focused on issues relating to sedation. The mean overall methodology quality score (maximum = 100) was 46 for randomized clinical trials and 33 for noncontrolled studies.
The effectiveness of a regional block for cataract surgery has traditionally been assessed by describing the completeness and adequacy of globe akinesia (i.e., prevention of eye movement) and pain control.
Regarding globe akinesia, there was strong evidence of equivalent effectiveness of peribulbar and retrobulbar anesthesia. There was insufficient evidence to compare subconjunctival/sub-Tenon's anesthetic block with peribulbar and retrobulbar blocks regarding akinesia. However, the rates of adequate akinesia appeared similar across the three techniques. There was weak evidence that adding hyaluronidase or using certain specific anesthetic agents over others produced superior akinesia. There was insufficient evidence to reach any conclusion regarding the relationship between akinesia and the volume of anesthetic used or the speed of injection.
Regarding pain associated with administration of the block, there was weak evidence to suggest that peribulbar injection was slightly less painful than retrobulbar injection, moderate evidence that subconjunctival/sub-Tenon's block was less painful than retrobulbar block, and insufficient evidence that subconjunctival/sub-Tenon's block was less painful than peribulbar block.
Regarding pain control during surgery, all of the major classes of techniques reported yielded good or excellent intraoperative pain control. The evidence was strong that retrobulbar and peribulbar techniques produce equivalent pain control during cataract surgery, and there was moderate evidence indicating superiority of pain control using subconjunctival/sub-Tenon's approaches compared with retrobulbar block. There was insufficient evidence to determine whether peribulbar or subconjunctival/sub-Tenon's anesthesia results in better pain control during surgery. There was strong evidence that retrobulbar block results in less pain during cataract surgery than topical anesthesia, moderate evidence that peribulbar block results in less pain during cataract surgery than topical anesthesia, and weak evidence that subconjunctival/sub-Tenon's block produces better pain control than topical anesthesia during cataract surgery.
Regarding specific agents used for local anesthesia, virtually all agents reported had high rates of excellent pain control, and there was insufficient evidence to determine if some agents produced better pain control during surgery than others.
Complications related to different anesthesia techniques were rarely and not systematically reported in the literature. The most important ocular and systemic complications are sufficiently rare that the reported frequency in the reviewed studies was almost invariably zero. Comparison of complication rates was also limited by wide variation in outcome definitions.
Regarding sedation strategies, weak evidence was found that intravenous or intramuscular sedation or analgesia is associated with improved anxiety control, pain relief, and patient satisfaction. There was insufficient evidence to suggest that one sedative or analgesic regimen was superior to another.
An analysis of a large Medicare claims data set was directed at ascertaining risk factors for readmission within 1 week following cataract surgery. Increasing age, medical comorbidity, and inpatient surgery were found to be predictive of readmission. Risk of readmission was greater for surgery performed in an office-based setting, but the relatively small number of individuals undergoing surgery in this setting limited the significance of this finding.
A decision analysis of alternative anesthesia management strategies indicated that strategies employing retrobulbar or peribulbar block yielded higher respondent preference values from medical experts than strategies employing topical anesthesia. In addition, among strategies employing retrobulbar or peribulbar block, the availability of an anesthesiologist either on call or present to provide intravenous sedation was preferred over having no anesthesiologist present. Having an anesthesiologist present for every case was associated with increased costs, albeit at increased preference values relative to simply having an anesthesiologist on call. Additional input from patients regarding their preferences and further clinical research are needed to validate the findings of the decision analysis.
An analysis of data on patient reports of their cataract surgical experience based on 19,250 surgeries from the Study of Medical Testing for Cataract Surgery indicated a high level of satisfaction with anesthesia management regardless of strategy, greater intraoperative pain with topical than injection anesthesia, and a greater rate of postoperative drowsiness and nausea when intravenous agents were used.
High priorities for additional research are improving the methodological quality of studies in the field, assessing patient (and surgeon) preferences (utilities) for different anesthesia management strategies and outcomes, and assessing the cost-effectiveness of intravenous sedation and monitoring by anesthesia personnel.
A variety of commonly employed anesthesia management strategies for cataract surgery appear to be safe and highly effective. Topical anesthesia does not provide as complete pain control as do the various injection techniques, although this technique is clearly quite effective and avoids rare complications potentially associated with injection techniques. There is only weak evidence that intravenous or intramuscular sedation or analgesia improve anxiety control, pain relief, and patient satisfaction with cataract surgery.
This document is in the public domain and may be used and reprinted without permission, except those copyrighted materials noted, for which further reproduction is prohibited without the specific permission of copyright holders.
Schein OD, Friedman DS Fleisher LA, et al. Anesthesia Management During Cataract Surgery. Evidence Report/Technology Assessment No. 16. (Prepared by the Johns Hopkins University Evidence-based Practice Center under Contract No. 290-097-0006.) AHRQ Publication No. 01-E017. Rockville, MD: Agency for Healthcare Research and Quality. December 2001.
Surgery for age-related cataract is the highest volume surgical procedure performed on Medicare beneficiaries. Approximately 1.5 million surgeries were performed on this population in 1996. Cataract surgery is performed almost exclusively as an outpatient procedure. It usually involves the administration of a local anesthetic in addition to systemic sedation administered by an anesthesiologist or nurse anesthetist.
Previous research has indicated substantial national and international variation in anesthesia management strategies for cataract surgery. The most common forms of local anesthesia include injection techniques (retrobulbar, peribulbar, subconjunctival/sub-Tenon's) and topical anesthesia. Sedating agents given orally or intravenously are commonly used to reduce patient anxiety and discomfort.
Surgeons' and anesthesiologists' preferences, as well as patient characteristics, are believed to influence the choice of anesthesia management for cataract surgery. However, there is uncertainty as to which strategy or strategies provide the best mix of patient comfort, surgical outcomes (e.g., pain control, ease of performing surgery), and freedom from anesthesia-related complications (e.g., brainstem anesthesia, retrobulbar hemorrhage, globe perforation). Therefore, in October 1998, the Agency for Health Care Policy and Research, now renamed the Agency for Healthcare Research and Quality (AHRQ), awarded a contract to the Johns Hopkins University Evidence-based Practice Center to prepare an evidence report on the management of local anesthesia and sedation during surgery for age-related cataract.
The principal objective of this evidence report is to summarize the published literature on the risks and benefits associated with the use of one form of regional anesthesia over another and the risks and benefits associated with different approaches to sedating the patient for cataract surgery. Two key questions were addressed in the literature abstraction process:
What are the risks and benefits associated with the use of one form of regional anesthesia over another?
What are the risks and benefits associated with different approaches to sedating the patient for cataract surgery?
For the first question, published studies comparing common forms of local anesthesia, including injection techniques and topical anesthesia, were reviewed. This question included issues related to patient characteristics, complications, choice of agent, training, and evidence for supplemental agents to enhance local anesthesia performance (e.g., heat and pH adjustment). The second question included issues related to complication rates, specific sedation strategies, level and intensity of monitoring, and the presence of evidence supporting the use of sedation.
An article was included in the evidence report if it (1) addressed cataract surgery using local anesthesia (with or without sedation) in an adult population, (2) was a controlled trial or a case series with more than 100 cases, and (3) provided outcomes specifically related to the research questions described above. In addition to data collected on risks and benefits, further information of interest included setting of surgery, intraoperative monitoring, patient comorbidity, choice of agent, the prior training of personnel, and use of supplemental agents.
The specific questions addressed in the evidence report were identified through consultation by the study team with a core panel of clinical experts. Electronic searches were conducted in PubMed and CENTRAL, the Cochrane Collaboration's database of controlled trials. PubMed includes publications from 1966 to the present. CENTRAL includes controlled trials from 1948 to the present. Additionally, principal ophthalmology- and anesthesiology-related journals, as well as reference lists from major reviews, were hand searched. The medical subject heading (MeSH) terms used in the searches included cataract, anesthesia, hypnotics, and sedatives. The literature considered was not limited to randomized trials but also included nonrandomized controlled trials and case series of 100 or more patients.
Of 1,857 potentially relevant citations identified, 739 were unique, appeared to meet the inclusion criteria, and were subsequently included in the abstract review process. All included studies were published between 1968 and 1999. After full review of abstracts and available published studies, 141 articles were identified that met all the eligibility criteria. Pairs of reviewers assessed study quality and abstracted data.
The results are presented in evidence tables, where the quality of evidence for specific questions is graded as strong, moderate, weak, or insufficient. The report also includes supplemental analyses: an analysis of early postoperative morbidity and mortality based on Medicare claims data, a decision analysis comparing alternative management strategies, and an analysis of patient perceptions of different anesthesia strategies from the Study of Medical Testing for Cataract Surgery.
Of the 141 studies reviewed, 122 focused on either local anesthesia techniques or local techniques in combination with sedation strategies. Of these, 86 were randomized clinical trials and 36 were noncontrolled studies including 100 or more patients. Nineteen studies, all of which were randomized clinical trials, specifically focused on issues related to sedation. The mean overall methodology quality score (maximum = 100) was 46 for randomized clinical trials and 33 for noncontrolled studies. There were significant issues in all quality domains examined. However, the lowest scores were in the areas of study representativeness, issues relating to methodologic bias, and adequacy of the description of therapy.
There was strong evidence that indicated no difference between peribulbar and retrobulbar anesthesia in achieving globe akinesia for cataract surgery. There was insufficient evidence to compare subconjunctival/sub-Tenon's anesthetic block with peribulbar and retrobulbar blocks. However, the rates of adequate akinesia appeared to be similar across the three techniques. There was weak evidence that adding hyaluronidase or using specific anesthetic agents instead of others produced superior akinesia. There was insufficient evidence to reach any conclusion regarding the relationship of block effectiveness to volume of anesthetic used or speed of injection.
There was weak evidence to suggest that peribulbar injection was slightly less painful than retrobulbar injection, moderate evidence that subconjunctival/sub-Tenon's block was less painful than retrobulbar block, and insufficient evidence that subconjunctival/sub-Tenon's block was slightly less painful than peribulbar block.
All of the major classes of techniques reported yielded good or excellent intraoperative pain control. The evidence was strong that retrobulbar and peribulbar techniques produce equivalent pain control during cataract surgery, and there was moderate evidence indicating superior pain control with the use of subconjunctival/sub-Tenon's approaches compared with retrobulbar block. There was insufficient evidence to determine whether peribulbar or subconjunctival/sub-Tenon's anesthesia results in better pain control during surgery. There was strong evidence that retrobulbar block results in less pain during cataract surgery than topical anesthesia, moderate evidence that peribulbar block results in less pain during cataract surgery than topical anesthesia, and weak evidence that subconjunctival/sub-Tenon's block results in less pain during cataract surgery than topical anesthesia.
Virtually all agents reported had high rates of excellent pain control. There was insufficient evidence to determine whether some agents produced better pain control during surgery than others.
Complications related to different anesthesia techniques were rarely and not systematically reported in the literature. The most important ocular and systemic complications (e.g., globe perforation, myocardial infarction) are sufficiently rare that the reported frequency was almost invariably zero. Comparison of complication rates was also limited by wide variation in outcome definitions.
Weak evidence was found that intravenous or intramuscular sedation or analgesia is associated with better anxiety control, pain relief, and patient satisfaction than the lack of such sedation or analgesia. There was insufficient evidence to suggest that one analgesic regimen was superior to another.
Three supplemental analyses were performed:
Analysis of a large Medicare claims data set -- This analysis was directed toward ascertaining risk factors for readmission within 1 week of cataract surgery. Increasing age, medical comorbidity, and inpatient surgery were predictive of readmission. Risk of admission was greater for surgery performed in an office-based setting, but the relatively small number of individuals undergoing surgery in this setting limited the significance of this finding.
Decision analysis of alternative anesthesia management strategies -- This decision analysis indicated that respondents, who were medical experts, had higher preference values for strategies employing retrobulbar or peribulbar block than for strategies employing topical anesthesia. In addition, among strategies employing retrobulbar or peribulbar block, they preferred having an anesthesiologist either present or on call to provide intravenous sedation over having no anesthesiologist present. However, having an anesthesiologist present for every case was associated with increased costs, albeit at increased preference values, relative to simply having an anesthesiologist on call. Additional input from patients regarding their preferences and further clinical research are needed to validate the findings of the decision analysis.
Analysis of data on patient reports of their cataract surgical experience -- Based on 19,250 surgeries from the Study of Medical Testing for Cataract Surgery, this study indicated a high level of satisfaction with anesthesia management regardless of strategy, greater intraoperative pain with topical than with injection anesthesia, and a greater rate of postoperative drowsiness and nausea when intravenous agents were used.
The published evidence and supplemental analyses indicate that a variety of strategies for anesthesia management of cataract surgery are safe and effective. Our findings do not indicate that a particular strategy is sufficiently superior to others to warrant a change in current practice or a rigid guideline for anesthesia care during cataract surgery. However, several high priorities for future research were identified. First, the methodologic quality of clinical trials in the field should be improved. Specifically, far greater attention should be paid to issues relating to representativeness, description of the intervention, patient comorbidities, length of the surgery, and the standardization of outcomes to allow comparison across studies. Second, there is a clear need for information on patient preferences (utilities) for different anesthesia management strategies and outcomes. For example, important tradeoffs are made between the advantages of pain control and depth of sedation on the one hand and the disadvantages of postoperative drowsiness and medication-related complications on the other. Bringing the patient perspective into our understanding of optimal anesthesia management strategies would be very helpful. A better understanding of surgeon preferences for alternative practices would also be important. Finally, the cost effectiveness of intravenous sedation and of monitoring by anesthesia personnel should be assessed. Our preliminary decision analysis suggests that the combination of oral sedation with a local block and an anesthesiologist on call may be the most cost-effective approach. However, further research in this area, which would include preference values collected from patients and additional clinical evaluation, is warranted before any final conclusion can be reached.
Surgery for age-related cataract is the highest volume surgical condition in the Medicare population. Approximately 1.5 million cataract surgeries were performed on Medicare beneficiaries in 1996 (Steinberg, Javitt, Sharkey et al., 1993). For the past 15 years, cataract surgery in the United States has been performed almost exclusively as an outpatient procedure using a variety of local anesthetic techniques, typically in conjunction with systemic sedation.
Local analgesia for cataract surgery may be administered through either injection (peribulbar, retrobulbar, subconjunctival, etc.) or the use of topical anesthetic drops. Choice of local anesthesia technique is largely determined by surgeon preference. Complications that may rarely result from the use of local block anesthesia include orbital hemorrhage, globe perforation, and brain stem anesthesia (Davis and Mandel, 1986). The use of topical anesthesia eliminates the risk of these complications but may not provide complete anesthesia.
Preoperative and/or intraoperative sedation usually accompanies the use of injection techniques for local anesthesia and may be used with topical anesthesia. Anesthesiologist preferences and patient characteristics both influence the choice of sedating technique and agent. The use of these techniques is felt to reduce patient anxiety and decrease patient discomfort during local injection and surgery. However, patients undergoing surgery for age-related cataract often have comorbidities (e.g., heart disease, diabetes mellitus) that may impose a risk of complications related to sedation (e.g., perioperative hypertension, arrhythmia, myocardial ischemia) (Cataract Management Guideline Panel, 1993). The use of intraoperative sedation also requires the use of intraoperative monitoring of vital functions, although it is not clear what level of monitoring is adequate and which operating room personnel should act as monitors. There appears to be substantial variation, especially internationally, in the use of intravenous sedation and anesthesiologists/nurse anesthetists during cataract surgery. For example, in the United States and Canada, an anesthesiologist/nurse anesthetist is in attendance for virtually every case, whereas in Denmark, the presence of an anesthesiology professional during cataract surgery is exceptional (Norregaard, Schein, Bellan et al., 1997).
The objectives of this evidence report are to: (1) identify the most important questions pertinent to anesthesia management for surgery for age-related cataract; (2) assess the published literature as to quality and content regarding these questions; and (3) inform practice and/or elucidate the need for future funded research, based on the literature findings.
In October 1998, the U.S. Agency for Health Care Policy and Research, now renamed the Agency for Healthcare Research and Quality (AHRQ), awarded a contract to the Johns Hopkins University Evidence-based Practice Center (EPC) to prepare an evidence report on the management of local anesthesia and sedation during surgery for age-related cataract. The task was to formulate a report that incorporated the best available evidence on this topic. The project consisted of recruiting a group of experts, identifying a target patient population, identifying relevant questions, performing a comprehensive literature search, constructing evidence tables, performing a decision analysis, and submitting the report for extensive peer review.
We identified a core group of five clinically oriented technical experts who provided key input to the project. This group included a representative of the principal partner, the American Academy of Ophthalmology. The core group of technical experts included:
Jacqueline Harden, CRNA, a Certified Registered Nurse Anesthetist in private practice in Atlanta, Georgia.
Marc A. Feldman, M.D., M.H.S., Director of Ophthalmic Anesthesia, Cleveland Clinic Foundation, an anesthesiologist with both methodological training and extensive clinical experience.
Stephen A. Obstbaum, M.D., Clinical Professor of Ophthalmology at New York University and Chief of Ophthalmology at the Lenox Hill Hospital in New York City, an experienced cataract surgeon who has served as the president of both of the two leading professional organizations in ophthalmology (the American Academy of Ophthalmology and the American Society of Cataract and Refractive Surgery). Dr. Obstbaum represented the American Academy of Ophthalmology.
Brent G. Petty, M.D., Associate Professor of Medicine at the Johns Hopkins University School of Medicine, an experienced clinician who directed the Medical Consultation Service for the Wilmer Eye Institute from 1979 to 1997. He also has extensive experience in evidence-based medicine.
Harry C. Wong, M.D., Emeritus Professor of Anesthesiology at the University of Utah, an anesthesiologist who is internationally recognized as an expert in ambulatory anesthesia, particularly with respect to issues of safety and quality assurance.
Representatives were identified from a range of other stakeholder organizations, including the American Association of Family Physicians (AAFP), the American Association of Nurse Anesthetists (AANA), the American Society of Anesthesiologists (ASA), the American Society of Cataract and Refractive Surgery (ASCRS), Blue Cross/Blue Shield, the Society for Ambulatory Anesthesia (SAMBA), and the Health Care Financing Administration (HCFA). These individuals aided in the identification of the relevant questions and served as peer reviewers of the evidence report. These peer reviewer representatives included physicians, nurse anesthetists, and representatives of professional organizations, government agencies, health plans, and industry (Appendix A). We contacted a number of consumer (patient) organizations but were not able to recruit a representative. However, a representative from the Anesthesia Patient Safety Foundation was identified and participated as a peer reviewer.
The target population addressed by this evidence report is adult patients undergoing surgery for age-related cataract under local anesthesia with or without systemic sedation in ambulatory surgery centers and hospital settings. The target audience is health care professionals involved in the care of adult patients undergoing surgery for cataract.
The study team devised an initial list of potential questions. The preliminary list of questions was discussed with ophthalmologists and anesthesiologists external to the study team to add other relevant questions. Following these discussions, the study investigators prepared a letter that included a list of the potential questions regarding the management of anesthesia for cataract surgery (Appendix B). Through the use of this letter, each technical expert and peer reviewer was asked to rate independently the importance of each proposed question from the perspective of his/her own profession or organization. Based on the responses to the letter and a conference call with the technical experts, we concluded that the literature review would focus on the key areas of regional anesthesia, sedation, and patient characteristics. The following questions were identified to be addressed in the evidence report:
What are the risks and benefits associated with use of one form of regional anesthesia over another? This question includes issues relating to patient characteristics, complications, choice of agents, training, and use of supplemental measures to enhance local anesthesia performance (e.g., heat and pH adjustment).
What are the risks and benefits associated with different approaches to sedating the patient for cataract surgery? This question also includes issues related to patient characteristics, complication rates, specific sedative strategies, level and intensity of monitoring, and the presence of evidence supporting the use of sedation.
Having defined the questions to be addressed in the evidence report, we constructed a model of the causal pathway of anesthesia management for cataract surgery (Appendix C). Patient outcomes are influenced by all the factors shown. The provider factors are specialty, geographic location, and personnel.
Patient factors such as age and medical and ocular comorbidities are certain to influence outcomes such as recovery time and patient satisfaction. Health system factors, including where the procedure is performed, might also impact the results. One might postulate that medically complicated patients who undergo surgery in ambulatory settings might be at greater risk of having a poor outcome if a rare adverse medical event (e.g., acute myocardial infarction) occurs.
During surgery there is a complex interaction between the anesthesia management strategy, surgical technique, and patient factors that may influence outcomes. Ophthalmic anesthesia involves the use of injection techniques or eye drops to control local pain in the eye. Choice of ophthalmic anesthesia technique may influence the concentration and choice of preoperative or intraoperative sedation agents, which in turn affect the level of monitoring. For example, deep sedation is often used just prior to administering a retrobulbar block. This may increase the need for medical interventions during surgery, especially if the patient is frail. This in turn may increase the intensity of monitoring that is required to complete the surgery safely. Initial deep sedation may not be needed with topical anesthesia, but ongoing intraoperative sedation might be required throughout the duration of the surgery using this approach. Patient satisfaction and his/her assessment of pain control may also depend on the type of sedatives used as well as the level of sedation. Amnestic agents may cause the patient to forget the pain that was felt during an operation. Deep sedation may increase patient satisfaction if the patient prefers to sleep through the operation.
Finally, surgeon factors such as operating speed may greatly influence the anesthesia needs and patient outcomes. A 10-minute procedure is less likely to result in adverse anesthesia-related events than one that takes over an hour. If pain is felt, its impact is brief when the surgery is performed rapidly.
Several literature sources were used in order to identify all studies that were potentially relevant to the study questions examined in this evidence report. Preliminary searches were completed on PubMed, the online free access to MEDLINE provided by the National Library of Medicine. The results of these searches were used in the refinement of the questions and formed the basis for the database of citations used for this evidence report.
The electronic searches were conducted in PubMed and CENTRAL, the Cochrane Collaboration's database. The strategies used in the searches are included in Appendix D. The searches were augmented by a hand search of 10 ophthalmology- and anesthesia-related journals identified by the principal investigators as high priority, the reference lists of relevant review articles, and the reference lists of a sample of studies included in the literature review (Appendix E). Only Issue 1 of The Cochrane Library for 1999 was searched. Issue 2 of The Cochrane Library was due to be released in April but was not shipped until early in May 1999. The search included articles published through April 1999.
Medical subject heading (MeSH) terms used in the searches included cataract, anesthesia, and hypnotics or sedatives as both a MeSH heading and key word. For the PubMed searches, the basic search strategy was combined with an optimal search strategy for retrieving controlled trials (Robinson, Hinegardner, and Lansing, 1998). The MeSH term "case report" was added to the search strategy to allow the inclusion of case studies.
All search results were downloaded or hand entered into a database of studies that were considered potentially eligible for inclusion in the literature review. On a weekly basis, or as needed, the abstracts of all newly identified citations were independently reviewed by two members of the study team to determine if they met eligibility criteria. The abstract review form (Appendix F) was developed based on the abstract review form used in the Evidence Report on Management of New Onset Atrial Fibrillation (McNamara, Bass, Miller et al., 2001). All citations not meeting eligibility criteria were coded with the reason for exclusion. For those articles without an abstract or where a reviewer could not determine whether the abstract or citation met the eligibility criteria, a full copy of the article was retrieved and reviewed. Disagreements between reviewers about whether an abstract or citation should be included in the review were adjudicated at a meeting of the entire study team. The database, developed using ProCite software, was used to facilitate the tracking of search results, the abstract review process, and the printing of reports regarding identification of relevant literature.
In the review of abstracts, the emphasis was on sensitivity rather than specificity. The following criteria were used to exclude articles from further consideration:
Addressed only general anesthesia.
Did not address human data.
Did not include adults.
Was not written in English.
Was a case series of fewer than 100 cases.
Had no original data.
Reviewers of the abstract also identified which of the major questions each article principally addressed.
Based on the results of the preliminary literature search (described above), we decided not to limit this systematic review to randomized clinical trials. We chose to include randomized clinical trials, nonrandomized controlled designs, and clinical series of 100 subjects or greater. Other eligibility criteria to be met for consideration of inclusion were relevance of the local anesthesia or sedation technique for practice in 1999 and clinical relevance of the assessed outcomes.
We developed two data abstraction forms to allow consistent data abstraction of the relevant information from each study. The Quality Assessment Form is included as Appendix G and the Article Content Abstraction Form is included as Appendix H. The forms were pilot tested and revised extensively before final application to the published evidence.
The Quality Assessment Form was created based on the form used in the Evidence Report on Management of New Onset Atrial Fibrillation (McNamara, Bass, Miller et al., 2001). That form was developed through review of quality assessment forms used in meta-analytic studies performed by investigators of this Evidence-based Practice Center, review of the literature, and the assistance of the Cochrane Collaboration. Following pilot testing and revision, the Quality Assessment Form used in this evidence report contained 32 questions, which were grouped into domains as follows: (1) representativeness and patient selection -- how completely the authors described the study subjects; (2) bias and confounding, including completeness of description of randomization and masking (if applicable); (3) intervention description -- completeness of the description of the protocol and other treatments received (if applicable); (4) outcomes and followup, including explicit description of the outcomes reported (e.g., efficacy and complications of block and/or sedation/anesthesia) and the subjects' withdrawing; and (5) statistical quality and interpretation. Each question could earn a point value from 0 to 2. The score is the percentage of the total points available in each category. The overall quality score for each study is the average of its five categorical scores.
The Article Content Abstraction Form was developed through an iterative process of discussions among our study team and pilot testing on sample manuscripts. The form was used to abstract data pertinent to both questions under consideration for this evidence report. For pilot testing, each pair of reviewers reviewed two articles independently. The form was revised as needed. Instructions for the use of the form were developed by consensus for the purposes of consistency.
For assessment of regional anesthesia, the following elements were included:
Description of the block (technique, location, personnel administering, agent, need for supplementation).
Anesthesia outcomes (akinesia, patient assessment of pain and satisfaction, health care provider assessment of pain and satisfaction, anesthesia failure).
For assessment of patient sedation, the following elements were included:
Intraoperative management (level of intraoperative monitoring, training of individual performing primary monitoring).
Intraoperative planned analgesia (route of administration, agent, and dose).
Outcomes of sedation (e.g., need for supplementation, patient recall during block/surgery, sedation score, anxiety score, hemodynamics).
Complications of sedation (e.g., general anesthesia, supplemental ventilation, narcotic reversal, angina, arrhythmia, unplanned hospital admission).
Other elements included were:
Patient demographics (age, gender, American Society of Anesthesia physical status classification, comorbidity).
Surgical and ocular variables (operating room time, surgical techniques, surgical center characteristics).
Surgical complications (e.g., lid ecchymosis, retrobulbar hemorrhage, nausea/vomiting, myocardial infarction, congestive heart failure, respiratory failure, hospitalization due to complications).
Each article was assigned a primary and secondary reviewer. At least one (and usually both) of the reviewers was an individual trained in research methodology and at least one (and usually both) were trained in ophthalmology, anesthesia, or internal medicine. For this project, three physicians in addition to the investigators named on the original project application, assisted in the review process: (1) John Kempen, M.D., M.P.H, an ophthalmologist trained in study methodology; (2) Jeffrey Magaziner, M.D., an internist and clinical scientist; and (3) Michael Sprintz, M.D., an anesthesiology resident.
The primary reviewer performed both the quality and content data abstraction and completed the relevant data abstraction forms. The secondary reviewer independently performed an assessment of study quality and then reviewed the data abstraction using the data abstraction forms completed by the primary reviewer. Differences between the reviewers were reconciled by the two raters in a conference to reach consensus. If a consensus could not be reached, one of the principal investigators served as a third reviewer to adjudicate the disagreement. The reviewers were not masked with regard to the author, institution, and journal.
All qualitative and quantitative data abstracted were entered into a computer database. This database was subsequently used for construction of evidence tables.
Three summary evidence tables (Evidence Tables 1, 2, and 3) were constructed to present data retrieved for overall description of the study, summary description of the intervention, and methodologic quality, respectively. A glossary of the abbreviations used in these tables precedes the evidence tables.
This table includes information on the source of the article, study design, exclusion criteria used in the study, sample size (number of surgeries), principal outcomes reported, study limitations, overall quality score, and a bottom-line description of each study's results.
This table includes information on the source of the article, description of local anesthesia technique, anesthetic agents used in the local block, additional agents or techniques employed, volume and location of local anesthetic administered, whether a facial/lid block was performed, surgical technique, mean surgical time (in minutes), and sedating technique employed.
This table includes information on the source of the article, exclusion criteria, scores on the individual quality scales, and the overall quality score.
The article abstraction forms were used to create a database using double data entry. The evidence tables were populated directly from the database. Subsequently, the accuracy of the evidence tables was assessed by comparison with the original articles and abstraction forms.
The synthesis of the data is based on the organization of the abstracted data around specific individual questions (Appendix I). For example, one of the suggested specific questions related to the efficacy of globe akinesia with different injection strategies. Manuscripts that provided information relative to this question were grouped together along with their principal results. A narrative description of the principal findings for each individual question is provided.
Evidence grades were assigned to the synthesis tables whenever a question involved the direct comparison of alternative techniques (e.g., intraoperative pain control with peribulbar versus retrobulbar anesthesia). The summary of the evidence for each table ends with a "conclusion" statement and the evidence grade. The evidence underlying the concluding statement was independently assessed by Drs. Schein, Fleisher, Friedman, and Bass. The method used to grade the evidence is based on a modification of the grading scheme employed by Garbutt, West, Carey et al. (1999) in their review of pharmacological treatment of alcohol dependence. The following schema was used in this project to grade the strength of the evidence:
Grade A (strong): Appropriate data are available for evaluating efficacy/safety of the interventions in question; overall, the population of patients studied is sufficiently large, and adequate controls have been used; data are consistent and indicate that the efficacy/safety of the intervention have been accurately described and that one intervention is clearly superior, equivalent, or inferior to another in terms of one or more well-defined outcomes.
Grade B (moderate): Appropriate data are available for evaluating safety/efficacy of the interventions in question; overall, the population of patients studied is sufficiently large; data are reasonably but not entirely consistent and indicate that the efficacy/safety of the intervention have been accurately described; the data indicate superiority (or equivalence) of one intervention over another for specific, well-defined outcomes; however, there is insufficient evidence to conclude definitively that the efficacy/safety of one intervention are clearly superior or inferior to another.
Grade C (weak): Some data are available for evaluating safety/efficacy of the interventions in question; overall, the population of patients studied is reasonably large; data indicate a trend supporting a benefit (or equivalence) of one intervention over another for specific, well-defined outcomes; however, there is insufficient evidence to conclude that one intervention is truly superior (or equivalent) to another.
Grade I (insufficient): Appropriate data are not available or an insufficient number of patients were studied to assess safety/efficacy of the intervention in question alone or in comparison to alternatives.
Whenever there was disagreement between the investigators as to the evidence grade, all of the evidence was simultaneously presented to the investigators and consensus achieved through discussion.
Based upon our completed review of the literature (as described in the following section), the scientific assumptions that underlie justification for a meta-analysis were not met. Most importantly, the heterogeneity of the study aims, content, and design and the way in which the outcomes were measured precluded one's ability to pool the data in a meaningful or acceptable fashion.
A full description of the methodology for the supplemental analyses completed for this evidence report may be found in the "Supplemental Analysis" section.
A draft copy of the evidence report was sent to the core group of clinically oriented technical experts and peer review representatives of stakeholder organizations described above in "Recruitment of Experts." Through the use of a standardized form (Appendix J), we solicited reviewer opinion and comment on a number of issues related to the completeness, clarity, and presentation of the evidence. Comments were received from 12 of the 17 reviewers (71 percent). All comments were reviewed and discussed by the study team. Changes were made to the document in response to reviewers' comments, and a summary of the comments and responses was submitted to AHRQ.
The completed searches yielded 1,857 potentially relevant citations, of which 739 were unique and subsequently included in the abstract review process. A summary of the searches completed, including the strategy used, date of search, number of citations retrieved, and number of unique citations identified, is included as Appendix K.
All 739 eligible abstracts were independently reviewed by two members of the study team to determine if they met eligibility criteria. For this process, we emphasized sensitivity rather than specificity. Disagreements between reviewers about whether an abstract or citation should be included in the review were adjudicated at a meeting of the entire study team. The abstract review phase ended on June 1, 1999. The citations identified during the hand-searching process were reviewed for eligibility. Of the 739 completed reviews of abstracts and citations, 195 (26 percent) were included in the full article review process and 544 (74 percent) were determined to be ineligible for the full article review. A summary of the results of the 739 abstract reviews may be found in Appendix L.
Of the 195 articles determined to be eligible for review, we were not able to obtain copies of three articles while the abstract review and full article abstraction were ongoing (Agrawal, Saxena, Nath et al., 1993; Krohn, Hovding, Seland et al., 1995; Schneider, Faulborn, and Von Hochstetter, 1989). Of the remaining 192 articles, 27.2 percent (51) were excluded during the quality review (Appendix M), leaving a total of 141. The reasons for exclusion and percent of articles excluded, by reason for exclusion, are listed in Appendix N. Articles were most frequently excluded because the data for cataract surgery were not reported separately from other types of ophthalmic surgery. The next most frequent reason for exclusion was that the outcomes assessed in the article were not directly relevant to the key outcomes prioritized for the evidence report (e.g., effect of injection on intraocular pressure, anesthetic agent concentration in aqueous, etc.).
Seventy-five percent of the studies included in this literature review were randomized controlled trials. The remaining studies utilized nonrandomized designs: 13 percent of studies were clinical series of 100 patients or greater, 9 percent were nonrandomized controlled trials, 2 percent were cross-sectional studies, and 1 percent were cohort studies.
Safety of regional anesthesia was addressed in 41 percent of the included studies. Information on the comfort of regional anesthesia and effectiveness of anesthesia/sedation was included in 58 percent and 45 percent of the studies, respectively. Sedation strategies were the focus of 17 percent of studies, and 4 percent of studies focused on personnel, setting, and/or outcomes.
The methodology for the article content assessment was described in Chapter 2. All studies included in this literature review reported some data on regional anesthesia. Approximately one-half (48 percent) of included studies reported some data on planned sedation. All of the studies reviewed reported at least some data on the range of regional anesthesia techniques of interest to this literature review: data on retrobulbar anesthesia were reported in 51 percent of studies, peribulbar in 49 percent, topical anesthesia in 25 percent, and subconjunctival/sub-Tenon's anesthesia in 14 percent. More than half of the studies reported on the use of additional agents for local block anesthesia: 65 percent reported data on the use of hyaluronidase, 25 percent on the use of epinephrine, and 4 percent on the use of other agents.
The clinical outcomes of principal interest regarding regional anesthesia include: (1) akinesia (adequacy of control of eye movement during surgery); (2) pain associated with administration of the regional anesthesia; (3) pain experienced intraoperatively; and (4) associated complications.
Nearly one-half (47 percent) of the articles reviewed reported some data on the complications of regional anesthesia. Complications of regional anesthesia for which data were abstracted include brainstem anesthesia, posterior capsular rupture, retrobulbar hemorrhage, and ruptured globe. Factors related to regional anesthesia for which the evidence was reviewed also included mean or median operating time, surgical technique, and assessment of akinesia.
The majority of articles reporting on planned sedation included data on planned intravenous sedation (65 percent). Data on oral preoperative medications were reported in 32 percent of the articles reporting on planned sedation. Preoperative oral agents for which data were available include diazepam, lorazepam, other agents, and placebo. Medication classes used for planned intravenous sedation and for which data were available include benzodiazepines, barbiturates, analgesics, propofol, other medications, and saline placebo.
The clinical outcomes of principal interest regarding planned sedation include: (1) anxiety/pain control; (2) hemodynamics; and (3) associated complications.
Complications of sedation/anesthesia for which data were abstracted include cardioversion, conversion to general anesthesia, cardiopulmonary resuscitation, endotracheal intubation, benzodiazepine reversal, ischemic event, seizure, and ventilation with bag and mask. Only 9 percent of articles reviewed included a report of adverse medical outcomes (myocardial infarction, new or worsened congestive heart failure, ventricular arrhythmia, stroke, transient ischemic attack, and respiratory failure). Hemodynamic outcomes (treatment for hypertension, tachycardia, bradycardia, and oxygen desaturation) were reported in only 8 percent of articles.
Finally, the content assessment of each article included an indication of whether the study supported, refuted, or did not address four key statements. Each statement appears below along with the percent of studies supporting, refuting, or unable to address the question.
(1) Local and intravenous analgesia is superior, to a clinically significant degree, to local alone:
| Supports | 2.2 percent |
| Refutes | 0.7 percent |
| Does not address | 97.0 percent |
(2) Use of intravenous sedation is superior, to a clinically significant degree, to not using intravenous sedation for:
Patient anxiety and satisfaction:
| Supports | 2.2 percent |
| Refutes | 1.4 percent |
| Does not address | 96.4 percent |
Effect on patient physiology (metabolic or hemodynamic):
| Supports | 2.2 percent |
| Refutes | 1.4 percent |
| Does not address | 96.4 percent |
Effect on patient outcomes:
| Supports | 0.0 percent |
| Refutes | 2.9 percent |
| Does not address | 97.1 percent |
Evidence Table 1 provides an overview of the 141 studies identified as relevant to the study questions and meeting inclusion criteria. Studies are listed in three groups (those addressing local anesthesia techniques, those addressing sedation strategies, and those addressing both of these issues) and sorted by author within each group. All included studies were published between 1968 and 1999, with articles reviewed through April 1999. Forty studies were carried out in the United States, 62 studies in Europe, and 39 in other countries. One hundred twenty-two studies focused on local anesthesia techniques, either alone or in combination with sedation strategies. Of these, 86 were randomized clinical trials and 36 were noncontrolled studies. Ninety-two of the 122 studies did not report the criteria for exclusion or provided an inadequate report of the exclusion criteria. The number of surgeries studied in the randomized clinical trials addressing local anesthesia techniques ranged from 20 to 570. Case series tended to be larger, with a range from 100 to 4,000 surgeries.
From the total group of studies listed in Evidence Table 1, 60 specifically addressed the efficacy of sedation, 36 addressed complications of sedation, 18 addressed both, and the remaining studies addressed neither. Efficacy included assessment of cooperation, recall of pain, anxiety, and satisfaction. Complications included both medical outcomes and hemodynamics. Seventeen studies included intravenous benzodiazepines, 8 included intravenous barbiturates, 24 included intravenous analgesics, and 7 included intravenous propofol, with overlap between the groups. Twenty-seven studies described preoperative oral medications. Placebo controls were included in six randomized trials.
This table provides a detailed description of the interventions in each study, including details about the kind of regional anesthesia or sedation given, the specific agents, and supplemental techniques. Columns are provided on presence or absence of facial block, cataract surgical technique, and mean surgical time because the study team felt that these parameters were very important in determining and interpreting the effectiveness of the techniques and studies. Whether or not a lid block was given is listed because the administration of a lid block likely increases the pain associated with the delivery of anesthesia. In addition, the cataract removal technique is likely to influence the pain of the procedure (with clear cornea phacoemulsification less likely to cause pain than standard extracapsular cataract extraction requiring multiple sutures). Finally, mean surgical time is reported because patient comfort and pain control are certainly related to how long the surgery takes. This table includes 105 studies that are randomized controlled trials and 36 others. Overall, the cataract removal technique could be determined in only 38 percent of articles. Mean surgical time was reported in only 20 percent.
As this table demonstrates, retrobulbar and peribulbar techniques varied significantly. Agents studied for retrobulbar and peribulbar blocks included bupivacaine, lidocaine, etidocaine, prilocaine, ropivacaine, and mepivicaine. Agents studied for topical anesthesia included lidocaine, bupivacaine, oxybuprocaine, intracameral lidocaine, tetracaine, proparacaine, and amethocaine. Studies also varied based on the characteristics of needles used to administer the injections.
This table summarizes the data on study quality. For each domain, the score is the percentage of the total possible points in that domain, ranging from 0 to 100. The overall quality score derives from study quality evaluated in five domains: representativeness of the population, bias and confounding, adequacy of the description of the treatment, outcomes assessment, and statistical analysis. We report scores in all domains as well as an overall score so that readers can form their own impression of the strengths and weaknesses of individual studies. In addition, we hope that this review will highlight issues relevant to the design of future trials. As a general consideration, it is important to keep in mind that our quality assessment of published reports is limited, by definition, to whatever is reported in the manuscript. Therefore, a limitation of using published reports to assess study design quality is that the evaluation is an assessment of both design and reporting quality.
Overall, 141 manuscripts were assessed for quality. Of these, 105 (75 percent) were controlled trials and 36 (25 percent) were uncontrolled trials or case series.
The mean value and range of scores for each domain and overall are presented in Appendix O. Scores for the bias and statistical quality scales are presented for controlled trials only. For controlled clinical trials, the mean overall score was 46 percent, with a range from 11 percent to 76 percent; 57 percent of these studies had an overall quality score of less than 50 percent. For the uncontrolled trials and case series, the mean overall score was 33 percent, with a range from 3 percent to 75 percent; 80 percent of these studies had an overall quality score of less than 50 percent.
Regarding representativeness, the mean score was 38, with a range from 0 to 100. Although a portion of this variability likely represents variability in reporting rather than true representativeness of the study population, it nevertheless makes it difficult for clinicians to know whether the results of these studies are likely to apply to the types of patients they see in their own practices. There is also significant variation in quality scores relating to bias and confounding (mean 48; range 0 to 100). The relatively low scores reflect the frequent lack of adequate masking of treatment supervisors, patients, and outcome assessors, and the absence of provision of adequate data on potentially important differences between study groups at baseline. For description of therapy, the mean score was 37, with a range from 0 to 86. Frequently, weaknesses were found in the description of ancillary medications or procedures given to each treatment group (e.g., the kind of intravenous sedation used in a study primarily evaluating regional anesthesia). For outcomes the mean was 55 percent, with a range from 0 percent to 80 percent, and for statistical quality the mean was 40 percent, with a range from 0 percent to 75 percent.
The following section summarizes the evidence available in the literature regarding the key clinical questions that had previously been chosen. The methodology used to grade the evidence was described in Chapter 2. Wherever the question involved the direct comparison of alternative techniques (e.g., intraoperative pain control with peribulbar versus retrobulbar anesthesia), the summary of the evidence ends with a conclusion statement and an evidence grade.
This section summarizes the evidence comparing various techniques of regional anesthesia regarding the outcomes of akinesia, pain, and complications. Whenever there existed published research making direct comparisons of alternative techniques, the findings are summarized and a conclusion accompanied by an evidence grade is given. Additional data on the techniques that could be abstracted from manuscripts containing relevant information (but where the techniques of interest were not directly compared) are also summarized in this section, but without the inclusion of evidence grades. Evidence grades were not applied to these summary sections because the contributing evidence was so heterogeneous that it could not be assessed in a uniform way.
The variability of the study designs and outcomes measured limits one's ability to synthesize the literature and address certain outcomes of interest. For example, one might be interested to ascertain if the characteristics (e.g., length, gauge, sharpness) of the needle used for an injection technique influenced the outcome. However, in the absence of direct comparisons, it is impossible to reach firm conclusions. Any possible effect of needle attributes is hopelessly confounded by other factors differing in each study, such as the injection technique itself, anesthetic choice, and presence/absence of sedation. This methodologic issue plagues many questions, particularly those relating to perception of pain during the block and surgery. The techniques and metrics for measuring pain varied substantially by study, and more importantly, the studies addressing pain perception varied regarding whether intravenous sedation was used. This, among other factors (variable surgical technique, operating time, etc.), is likely to have contributed significantly to the heterogeneity of the findings.
Seven randomized trials directly addressed this question. Two of these studies reported the percentage of patients for whom complete akinesia was obtained (Ali-Melkkila, Virkkila, Leino et al., 1993; Athanikar and Agrawal, 1991). There was no difference between the two techniques, with complete akinesia rates of over 70 percent reported for both arms in the two studies.
Three studies reported the percentage of subjects for whom akinesia was poor. One study (Ali-Melkkila, Virkkila, Leino et al., 1993) (450 subjects, quality score 58) reported twice the rate of poor akinesia using one peribulbar technique (one injection inferotemporal and one injection superomedial) than using an alternative technique (one injection inferotemporal and one injection inferomedial). The rate was 12 percent with retrobulbar, 19 percent with the first peribulbar technique, and 11 percent with the second peribulbar technique. Another study (Murdoch, 1990) (100 subjects, quality score 44) reported a much higher rate of poor akinesia with retrobulbar (single inferotemporal injection) than with peribulbar (20 percent versus 6 percent). The third study (Wong, Koehrer, Sutton et al., 1993) (150 subjects, quality score 65) reported a very high rate of poor akinesia with a single inferotemporal retrobulbar injection (26 percent). Lower rates of poor akinesia were found for superomedial retrobulbar injection (8 percent) and peribulbar injection (10 percent).
Three other studies did not report on the percentage with complete or poor akinesia, but did compare retrobulbar and peribulbar block using mean scores for akinesia (Saunders, Sturgess, Pemberton et al., 1993; Weiss and Deichman, 1989; Whitsett, Balyeat, and McClure, 1990). All three found no difference in akinesia comparing the two groups.
These studies indicate that peribulbar and retrobulbar techniques appear to provide equivalent akinesia. However, the failure rates may be higher with one or the other approach depending on the exact injection technique employed.
Conclusion: There is no difference between peribulbar and retrobulbar anesthesia in achieving akinesia. [Evidence Grade: A]
Two studies directly addressed this question. One large study (Kapran, Uyar, Eltutar et al., 1996) (570 subjects, quality score 25) compared sub-Tenon's to retrobulbar block and found that a higher percentage of patients in the sub-Tenon's group had complete akinesia (69 percent versus 41 percent) and fewer had poor akinesia (1 percent versus 7 percent). The second study (Khoo, Lim, and Yong, 1996) (106 subjects, quality score 46) reported similar akinesia with sub-Tenon's and retrobulbar block. However, 2 of 55 subjects in the sub-Tenon's group had residual movement that affected surgery, while none in the retrobulbar group had this problem.
The results of the two studies are inconsistent. However, the approaches used were not identical because the anesthetic agents were different in the two studies.
Conclusion: There is insufficient evidence in favor of either retrobulbar or subconjunctival/sub-Tenon's block for inducing akinesia. [Evidence Grade: I]
Two studies directly addressed this question. One study (Khurana, Sachdeva, Gombar et al., 1994) (200 subjects, quality score 30) found that subconjunctival/sub-Tenon's anesthesia was less successful than peribulbar block at producing akinesia (52 percent complete akinesia versus 85 percent). In addition, 19 percent in the subconjunctival/sub-Tenon's group had poor akinesia versus 8 percent in the peribulbar arm.
The second study was nonrandomized (Kollarits, Jaweed, and Kollarits, 1998) (200 subjects, quality score, 18) and found similar rates of complete akinesia in the peribulbar and sub-Tenon's groups (82 percent and 80 percent, respectively). Akinesia was assessed at the end of the case, however.
The results of the two studies are inconsistent. However, the techniques used were not identical.
Conclusion: There is insufficient evidence in favor of either peribulbar or subconjunctival/sub-Tenon's block for inducing akinesia. [Evidence Grade: I]
[Note: Studies (groups) where the technique was a combination of peribulbar and retrobulbar blocks are listed twice, once under each block type.] A total of 32 studies reported specific data on akinesia using peribulbar anesthesia. Nineteen of these (with 48 separate study groups) gave the percentage of patients with complete akinesia. Complete akinesia rates ranged from 26 percent to 100 percent.
Twenty-six percent of the studies reported that complete akinesia was achieved in 25 percent to 50 percent of patients; 25 percent of studies reported complete akinesia in 51 percent to 75 percent of patients; and 49 percent of the studies reported complete akinesia rates in over 75 percent of patients. One study reported 100 percent akinesia in all four study arms (Wong and Merrick, 1996). In one study (House, Hollands, and Schulzer, 1991), 5 of 14 arms had complete akinesia rates between 26 and 50 percent. In summary, 74 percent of the groups had greater than 50 percent of individuals with complete akinesia using a peribulbar block, even though a wide variety of techniques and agents were used.
A total of 15 studies (with 39 separate study groups) reported the rates of poor akinesia with peribulbar anesthesia. Poor akinesia rates ranged from 0 to 72 percent. Five arms (13 percent of study groups) reported that poor akinesia was achieved in over 40 percent of subjects. Three of these came from one study that assessed bupivacaine and lidocaine for peribulbar anesthesia (Loots, Koorts, and Venter, 1993). In general, however, the studies reported relatively low rates of poor akinesia with peribulbar block. Forty-four percent of study arms reported 10 percent or fewer patients had poor akinesia, 21 percent of studies reported poor akinesia in 11 to 20 percent of subjects, 13 percent of studies reported poor akinesia in 21 to 30 percent of subjects, and 10 percent reported poor akinesia in 31 to 40 percent of subjects.
One very large study, including over 1,000 individuals in each of three peribulbar arms, had complete akinesia in over 80 percent of cases and poor akinesia in 5 percent or fewer individuals in each of the three arms (Hamilton, Gimbel, and Strunin, 1988).
In summary, poor akinesia rates varied tremendously when peribulbar techniques were used. Nearly half of the studies reported rates below 10 percent, but 36 percent of studies reported rates over 20 percent.
[Note: Studies (groups) where the technique was a combination of peribulbar and retrobulbar blocks are listed twice, once under each block type.] A total of 20 studies reported specific data on akinesia using retrobulbar anesthesia. Thirteen of these (with 36 separate study groups) gave the percentage of patients with complete akinesia. Complete akinesia rates ranged from 23 percent to 100 percent.
One study reported a 23-percent complete akinesia rate in one of three arms (Ellingsson and Aasved, 1979). The other two arms had much higher rates (93 percent and 67 percent). The arm with the low rate used etidocaine 1 percent with hyaluronidase without epinephrine.
Fourteen percent of the studies reported complete akinesia in 25 percent to 50 percent of patients, 28 percent of studies reported complete akinesia in 51 percent to 75 percent of patients, and 58 percent of the studies reported complete akinesia rates above 75 percent. One study, which examined the effectiveness of sedation during cataract surgery, reported 100 percent akinesia in all six study arms (Boezaart, Berry, Laubscher et al., 1998).
In summary, 86 percent of the groups reported greater than 50 percent of patients with complete akinesia when using a retrobulbar block, even though a wide variety of techniques and agents was used.
A total of nine studies (with 22 separate study groups) reported the rates of poor akinesia with retrobulbar anesthesia. Wide variation was seen, as poor akinesia rates ranged from 0 to 63 percent. Two arms (9 percent of study groups) reported poor akinesia in over 40 percent of subjects. Thirty-six percent of studies reported 10 percent or fewer patients had poor akinesia, 27 percent of studies reported poor akinesia in 11 to 20 percent of subjects, 18 percent of studies reported poor akinesia in 21 to 30 percent of subjects, and 9 percent reported poor akinesia in 31 to 40 percent of subjects. In a report on seven groups in two studies (Sarvela, Nikki, and Paloheimo, 1993), five groups had poor akinesia in 20 percent of patients or more.
In summary, poor akinesia rates varied tremendously when using retrobulbar techniques. Thirty-six percent of the studies reported rates below 10 percent, while 36 percent of studies reported rates over 20 percent.
No study reported the percentage with complete akinesia. The percentage of subjects with poor akinesia was reported as 6 percent and 7 percent (Davis and O'Connor, 1989).
Nine studies provided abstractable data on this question. Four studies found a large improvement in the akinesia rate with the addition of hyaluronidase. One study (Abelson, Mandel, Paradis et al., 1989) (40 subjects, quality score 46) had complete akinesia in 70 percent of those in whom hyaluronidase was used versus 40 percent in those without it. No patients receiving hyaluronidase had poor akinesia, as opposed to 15 percent in the control arm. Another study supporting the efficacy of hyaluronidase (Bjornstrom, Hansen, Otland et al., 1994) (54 subjects, quality score 30) had 78 percent with complete akinesia when hyaluronidase was used versus 26 percent in the control group. Two other studies showed large improvements in akinesia rates with hyaluronidase in some arms of the study (House, Hollands, and Schulzer, 1991; Sarvela and Nikki, 1992a). House, Hollands, and Schulzer (1991) reported 96 percent complete akinesia when using hyaluronidase with bupivacaine and lidocaine versus 46 percent without adding hyaluronidase. The improvement was less when adding hyaluronidase to bupivacaine alone. Sarvela and Nikki (1992a) reported the lowest complete akinesia rate and the highest poor akinesia rate in the one arm not receiving hyaluronidase.
One additional study found a slightly higher rate of complete akinesia with hyaluronidase. In Prosser, Rodney, Mian et al. (1996) (50 subjects, quality score 56), 84 percent of patients had complete akinesia with hyaluronidase versus 68 percent without it.
The final four studies found similar rates in the two groups. Two of these studies detected greater akinesia among the control group. One of these studies (Mindel, 1978) (27 subjects, quality score 35) had a 75-percent complete akinesia rate in the control group versus a 60-percent rate in those receiving hyaluronidase. A larger study (Krohn, Seland, Hovding et al., 1993) reported 93 percent complete akinesia in the control group and 83 percent in the hyaluronidase group. Finally, two studies (Nathan, Benrhaiem, Lotfi et al., 1996 [139 subjects, quality score 28]; Johansen, Kjeldgard, and Corydon, 1993 [20 subjects, quality score 41]) reported identical rates in two groups.
Conclusion: There is evidence that adding hyaluronidase to local blocks produces better akinesia than not adding hyaluronidase. [Evidence Grade: C]
Nine controlled clinical trials directly compared anesthetic agents. Four studies looked at combinations of bupivacaine and lidocaine. One study (Davis and O'Connor, 1989) (54 subjects, quality score 53) found no difference between lidocaine 2 percent alone or when bupivacaine 0.5 percent was added. One study (Sarvela, Paloheimo, and Nikki, 1994) (82 subjects, quality score 58) found much higher rates of complete akinesia (95 percent versus 64 percent) when lidocaine 2 percent was added to bupivacaine 0.75 percent. A third study (Vettese and Breslin, 1985) (45 subjects, quality score 31) obtained nearly identical results comparing bupivacaine 0.5 percent with and without lidocaine 2 percent, but had much better akinesia when epinephrine was added to a block using both drugs. Only three groups were studied, so it is not clear if epinephrine added to bupivacaine alone would have had the same effect. The final study assessing these two agents (Loots, Koorts, and Venter, 1993) (151 subjects, quality score 45) reported slightly better results with bupivacaine 0.75 percent than bupivacaine 0.5 percent and no difference when lidocaine was added.
One study (Dopfmer, Maloney, Gaynor et al., 1996) (90 subjects, quality score 43) compared lidocaine 2 percent and bupivacaine 0.75 percent to prilocaine 3 percent for peribulbar anesthesia and found that prilocaine produced greater akinesia (61 percent with complete akinesia versus 26 percent).
One study (Huha, Ala-Kokko, Salomaki et al., 1999) (100 subjects, quality score 73) compared ropivacaine 1 percent to bupivacaine 0.75 percent. Complete akinesia rates were higher with bupivacaine (52 percent versus 32 percent).
Three studies compared etidocaine to other agents. One study with three arms (Ellingsson and Aasved, 1979) (92 subjects, quality score 20) found that etidocaine 1 percent was inferior to lidocaine 2 percent plus epinephrine and to etidocaine 1 percent plus epinephrine (93 percent complete akinesia and 4 percent poor akinesia with lidocaine versus 67 percent complete akinesia and 21 percent poor akinesia in the two arms where epinephrine was used). One study (Sarvela, 1993) (160 subjects, quality score 60) found etidocaine 1 percent and etidocaine 1.5 percent equivalent to bupivacaine 0.75 percent. One study (Thorburn, Thorn-Alquist, and Edstrom, 1976) (45 subjects, quality score 31) found etidocaine 1 percent and etidocaine 0.5 percent equal to mepivicaine.
Conclusions: Bupivacaine alone is as effective as bupivacaine and lidocaine at producing akinesia. [Evidence Grade: C]
Prilocaine produces better akinesia than a combination of bupivacaine and lidocaine. [Evidence Grade: C]
Lidocaine produces better akinesia than etidocaine. [Evidence Grade: C]
Bupivacaine produces better akinesia than ropivacaine. [Evidence Grade: C]
Etidocaine and bupivacaine produce similar akinesia. [Evidence Grade: C]
Etidocaine and mepivicaine produce similar akinesia. [Evidence Grade: C]
Only one study (Gillart, Bazin, Montetagaud et al., 1998) (140 surgeries, quality score 50) addressed the question of the effect of volume on pain during the block or surgery, but the findings are difficult to interpret because of the study design. Two low volume (9 ml) and two higher volume (13.5 ml) groups were assigned to rapid and slow injection speeds. The study found no large differences in the percentages with no pain and with severe pain in any of the groups. However, a larger volume of injection (13.5 ml) yielded a higher range of akinesia for both slow and fast injections than did the smaller volume (9 ml) -- 54 percent versus 40 percent and 83 percent versus 60 percent, respectively.
The same study (Gillart, Bazin, Montetagaud et al., 1998) (140 surgeries, quality score 50) directly addressed the effect of injection speed and found that when agents were injected more rapidly, the percentage with complete akinesia was higher. Volume and speed of injection had no significant effect on pain during surgery.
Ortiz, Blanco, Serra et al. (1995) addressed the question of the effect of volume on akinesia. When hyaluronidase was added to the injection, a larger volume injected did not result in increased akinesia. However, when hyaluronidase was not used, increasing the volume of anesthesia injected resulted in improved akinesia.
Conclusions: Increasing the volume of anesthetic agent from 9 ml to 13.5 ml confers a greater likelihood of akinesia. [Evidence Grade: C]
There are insufficient data to determine if alterations in speed of injection or volume improve pain control during the block or surgery. [Evidence Grade: I]
Four studies directly addressed this question. Three articles reported only the mean pain score on a scale from 0 to 10. The first article (Saunders, Sturgess, Pemberton et al., 1993) (85 surgeries, quality score 36) reported a mean pain score of 3.8 with retrobulbar versus 3.3 with peribulbar block. The second study (Murdoch, 1990) (100 subjects, quality score 44) also reported slightly higher mean pain scores for retrobulbar than peribulbar block (5.8 versus 4.8). The third study (Weiss and Deichman, 1989) (79 subjects, quality score 56) also reported slightly higher scores with retrobulbar than peribulbar block (2.2 versus 1.8).
Only one study (Wong, Koehrer, Sutton et al., 1993) (150 subjects, quality score 65) reported on the distribution of scores, with 42 percent and 60 percent feeling no pain in the two retrobulbar groups, while 32 percent in the peribulbar group fell into this category. No subject in any of the groups experienced severe pain during administration of the block.
Conclusion: The evidence indicates that peribulbar injection is slightly less painful than retrobulbar injection. [Evidence Grade: C]
All three studies directly addressing this question found less pain when administering subconjunctival/sub-Tenon's block than retrobulbar block. One study (Kapran, Uyar, Eltutar et al., 1996) (570 subjects, quality score 25) reported mild to moderate pain for all subjects using both methods, but mean pain scores were higher for the retrobulbar group (2.3 versus 1.8). The second article (Khoo, Lim, and Yong, 1996) (106 subjects, quality score 46) reported that patients had much less pain during the administration of the sub-Tenon's block than a retrobulbar block. Sixty-two percent reported no pain and no subjects reported severe pain with sub-Tenon's versus 2 percent with no pain and 16 percent with severe pain with a retrobulbar block.
The third study (Nielsen and Allerod, 1998) (130 subjects, quality score 59) compared retrobulbar, sub-Tenon's block, and topical anesthesia in subjects undergoing bilateral, simultaneous cataract extraction. The mean pain score (on a scale from 0 to 10) during administration of the block was low for both groups, but favored sub-Tenon's slightly (0.15 with sub-Tenon's block versus 0.87 with retrobulbar block).
Conclusion: The evidence indicates that pain during the administration of a subconjunctival/sub-Tenon's block is less than during retrobulbar block. [Evidence Grade: B]
Two studies directly compared the pain during administration of sub-Tenon's anesthesia with peribulbar block. One study (Briggs, Beck, and Esakowitz, 1997) (131 surgeries, quality score 26) found that far more individuals in the sub-Tenon's arm than in the peribulbar arm had no pain during the block (55 percent versus 22 percent). In addition, only 4 percent experienced severe pain with sub-Tenon's versus 11 percent with peribulbar block. The second study (Kollarits, Jaweed, and Kollarits, 1998) (200 surgeries, quality score 18) documented very low rates of any pain with both techniques. Although sub-Tenon's block had more patients with no pain (99 percent versus 91 percent), these extremely high rates are difficult to reconcile with the rest of the literature regarding the pain of injection anesthetics.
Conclusion: There is insufficient evidence to determine whether a peribulbar versus subconjunctival/sub-Tenon's approach is less painful while the anesthetic is being administered. [Evidence Grade: I]
[Note: Studies (groups) where the technique was a combination of peribulbar and retrobulbar blocks are listed twice, once under each block type]. A total of 13 studies addressed this question. Five studies with 12 arms reported the percentage with no pain during peribulbar injection, with a range of 0 to 85 percent. Four arms (33 percent) reported no pain in over 50 percent of subjects. One study (Bjornstrom, Hansen, Otland et al., 1994) (54 subjects, quality score 30) found that 85 percent of individuals given peribulbar injections with epinephrine and hyaluronidase had no pain versus 26 percent of those given the injection without these agents. Two of these 13 studies had 10 percent or fewer individuals report no pain with injection. The remaining six studies reported rates of 11 percent to 50 percent.
Eight arms of three studies reported the percentage of patients with severe pain during the injection. These percentages ranged from 0 to 50 percent, with 75 percent of studies reporting severe pain in 6 percent or fewer subjects. The one study with a 50-percent rate of severe pain (Bell and Butt, 1995) (60 surgeries, quality score 36) used a single peribulbar injection with lidocaine and hyaluronidase.
Seven of the studies reported mean pain scores. These give a sense of the amount of pain experienced by individuals but do not allow one to interpret whether or not the data are skewed, with many patients having no pain and some having a great deal of pain. Placing all reported scores on a scale from 0 to 10, the lowest mean score was 0.9 and the highest was 5.5. Seven (47 percent) of the arms had a mean score of 2.5 or less. Three arms (20 percent) had mean pain scores over 5 (Bell and Butt, 1995; Ursell and Spalton, 1996; Virkkila, Ali-Melkkila, and Kanto, 1992).
The amount of pain associated with peribulbar injections varied tremendously across the studies. This can be explained by the substantial variation in study design, including different approaches to measuring pain, different injection techniques, and different agents.
[Note: Studies (groups) where the technique was a combination of peribulbar and retrobulbar blocks are listed twice, once under each block type]. A total of eight studies addressed this question. Three studies with six arms reported the percentage with no pain during retrobulbar injection, with a range of 6 to 41 percent.
Eight arms of four studies reported the percentage of patients with severe pain during the injection. These percentages ranged from 9 to 33 percent.
Six of the studies reported mean pain scores. These give a sense of the amount of pain experienced by individuals but do not allow one to interpret whether or not the data are skewed, with many patients having no pain and some having a great deal of pain. Placing all reported scores on a scale from 0 to 10, the lowest mean score was 2.0 and the highest was 8.2. Five (33 percent) of the arms had a mean score of 2.5 or less.
The amount of pain associated with retrobulbar injections varied tremendously across the studies, but none of the studies used intravenous sedation prior to the retrobulbar block.
Only one study (Guise, 1996) directly addressed pain during administration of a subconjunctival/sub-Tenon's block. In this study, 68 percent of patients reported no pain, 31 percent reported the pain to be mild or moderate, and 1 percent reported the pain to be severe. Of note, no systemic sedation was used.
The only two studies to directly assess this question -- Patel, Clinch, Burns et al. (1998) (90 subjects, quality score 49) and Patel, Burns, Crandall et al. (1996) (128 subjects, quality score 52) -- found less pain on administration of retrobulbar than topical block. However, sedation was given "until unconsciousness" prior to administration of retrobulbar anesthesia.
Conclusion: There is insufficient evidence to compare pain during administration for topical versus retrobulbar block. [Evidence Grade: I]
Three of the four studies directly addressing this question found that peribulbar block resulted in more pain during administration than topical anesthesia. One study (Johnston, Whitefield, Giralt et al.,1998) (82 subjects, quality score 26) reported that the mean pain score was 2.5 out of 10 with peribulbar block versus 1.0 with topical anesthesia. Two articles reported on the distribution of pain scores during anesthetic administration, and both found significantly fewer subjects reporting no pain with peribulbar block than with topical anesthesia. One article (Roman, Auclin, and Ullern, 1996) (90 subjects, quality score 36) reported that no individuals reported pain with topical administration versus 22 percent of patients with mild to moderate pain with peribulbar block. The second article (Virtanen and Huha, 1998) (100 subjects, quality score 45) found that 92 percent had no pain with topical anesthesia, while only 4 percent of patients had no pain with peribulbar block.
One article (Uusitalo, Maunuksela, Paloheimo et al., 1999) (299 subjects, quality score 58) found similar amounts of pain with the administration of peribulbar and topical anesthesia (mean pain scores of 0.7 and 0.9, respectively), but intravenous sedation/anesthesia was routinely administered.
Conclusion: Topical anesthesia results in less pain during administration than a peribulbar block. [Evidence Grade: A]
The one study (Fukasaku and Marron, 1994) (348 subjects, quality score 11) that directly addressed this question compared two different subconjunctival/sub-Tenon's blocks to two topical groups. No patient in the two topical groups experienced pain during administration of anesthesia, while pain was variable in the subconjunctival/sub-Tenon's group, depending on technique.
Conclusion: There is evidence that topical anesthesia is less painful during administration than subconjunctival/sub-Tenon's block. [Evidence Grade: C]
Four studies directly addressed this question. Two found virtually identical results using the two techniques. The first article (Sanders, Ahmed, Craig et al., 1997) (100 surgeries, quality score 19) reported the mean pain score from 0 to 10 as 0.2 for peribulbar block and 0.1 for retrobulbar block. Both groups had 90 percent with no pain and 0 percent with severe pain. The second study (Saunders, Sturgess, Pemberton et al., 1993) (85 surgeries, quality score 36) only reported mean pain scores, with peribulbar block averaging 0 and retrobulbar block averaging 0.1. The authors concluded that the two approaches yielded equivalent pain control during surgery.
One study (Murdoch, 1990) (100 subjects, quality score 44) reported slightly higher mean pain scores for retrobulbar than peribulbar block (2.6 versus 1.9), but did not report on the distribution of those scores. The last study (Wong, Koehrer, Sutton et al., 1993) (150 subjects, quality score 65) compared two retrobulbar techniques to a peribulbar technique. The result of the inferotemporal retrobulbar injection was similar to that of the peribulbar injection (90 percent no pain, 0 percent severe pain with retrobulbar versus 92 percent no pain and 0 percent severe pain with peribulbar). The superomedial retrobulbar injection performed slightly better, with all 50 subjects reporting no pain.
Conclusion: The evidence indicates that retrobulbar and peribulbar techniques produce equivalent pain control during cataract surgery. [Evidence Grade: A]
Two of the three studies directly addressing this question found slightly better results with subconjunctival/sub-Tenon's block than with retrobulbar block. One study (Kapran, Uyar, Eltutar et al., 1996) (570 subjects, quality score 25) had no subjects without pain during surgery in either group. Six percent of subjects receiving retrobulbar blocks reported severe pain versus none in the subconjunctival/sub-Tenon's group. Mean pain scores on a 0 to 10 scale were higher for the retrobulbar group (2.7 versus 1.6). The second article (Khoo, Lim, and Yong, 1996) (106 subjects, quality score 46) reported much better pain control with subconjunctival/sub-Tenon's block than with retrobulbar block; 67 percent reported no pain and no subjects reported severe pain with subconjunctival/sub-Tenon's block versus 16 percent with no pain and 24 percent with severe pain with retrobulbar block.
The third study (Nielsen and Allerod, 1998) (130 subjects, quality score 59) compared retrobulbar, subconjunctival/sub-Tenon's, and topical anesthesia in subjects undergoing bilateral simultaneous cataract extraction. While the percentage with no pain was higher in the retrobulbar group (79 percent versus 64 percent), a larger number of subjects would not have retrobulbar anesthesia again (40 percent) than would not have subconjunctival/sub-Tenon's anesthesia again (16 percent).
Conclusion: The evidence indicates superior intraoperative pain control using subconjunctival/sub-Tenon's approaches compared with retrobulbar block. [Evidence Grade: B]
Only one controlled but nonrandomized trial directly addressed this question (Kollarits, Jaweed, and Kollarits, 1998) (100 subjects, quality score 18). The percentage of individuals with no pain during surgery was 76 percent in the peribulbar group and 79 percent in the subconjunctival/sub-Tenon's group. A second study also found similar results in the two groups (Briggs, Beck, and Esakowitz, 1997) (131 subjects, quality score 26), but did not present the data in a form that allowed one to determine the distribution or average of the pain scores.
Conclusion: There is insufficient evidence in the literature to determine if peribulbar or subconjunctival/sub-Tenon's block results in better pain control during cataract surgery. [Evidence Grade: I]
[Note: Studies (groups) where the technique was a combination of peribulbar and retrobulbar blocks are listed twice, once under each block type]. Twenty articles presented data on the effectiveness of peribulbar block at producing pain control. Nine articles with 16 arms presented mean scores for pain during surgery. Scores ranged from 0.1 (out of 10) to 1.9. Only three of the arms had scores over 1.0.
Thirteen studies reported the percentage with complete pain control during cataract surgery with peribulbar block. The percentage was 90 percent or greater in 16 (64 percent) of the 25 arms studied. The lowest reported rate of complete pain control was 74 percent.
[Note: Studies (groups) where the technique was a combination of peribulbar and retrobulbar blocks are listed twice, once under each block type]. Five articles presented data on the effectiveness of retrobulbar block at producing pain control. Two articles with eight arms presented mean scores for pain during surgery. The first study (Boezaart, Berry, Laubscher et al., 1998) (240 subjects, quality score 71) had six arms with mean pain scores all less than 0.7 (0-10 scale). The second article (Krause, Weindler, and Ruprecht, 1997) (70 subjects, quality score 42) investigated the effect of warming on retrobulbar blocks and found a mean pain score of 4.5 and 5.3 in the two groups. These are particularly high scores for pain during cataract surgery. That same study reported that no subjects had complete pain control and 26 percent and 31 percent had severe pain in the two retrobulbar groups. No other study in this review reported such poor results with retrobulbar anesthesia.
The remaining three studies that reported the percentage with no pain during cataract surgery had five arms. Two arms of one study reported 63 percent of patients with complete pain control. Two arms of another study reported 83 percent and 93 percent of patients had complete pain control, and the final study reported 100 percent of patients had complete pain control.
Five arms of four studies assessed pain during the surgery following administration of subconjunctival/sub-Tenon's block. Three studies reported the percentage of patients with no pain when a sub-Tenon's approach was used. One study (Fukasaku and Marron, 1994) reported that in one arm 85 percent of patients had no pain and 1.5 percent had severe pain, and in another arm 99 percent of patients had no pain. The approach used in the latter, less painful sub-Tenon's technique involved incising the conjunctiva 8 to 12 mm posterior to the superior limbus and using a blunt, curved cannula to inject 1 cc of lidocaine in the sub-Tenon's space. The second study reported 64 percent of patients had no pain and 0 percent had severe pain with sub-Tenon's block. The third study reported 90 percent of patients had no pain during surgery after a sub-Tenon's block.
One study reported the mean pain score during surgery. Using a sub-Tenon's approach, Manners and Burton (1996) reported a mean pain score of 0 (scale 0 to 10) in 25 subjects. Patients were asked after the surgery was completed to recall the pain felt during the procedure.
All four studies that directly addressed this question reported a higher percentage of subjects receiving retrobulbar blocks had complete pain control during surgery than did subjects receiving topical anesthesia. One study (Jolliffe, Abdel-Khalek, and Norton, 1997) (40 subjects, quality score 50) reported 32 percent of patients had no pain in the topical group versus 48 percent of patients in the retrobulbar group. Additionally, this study reported 21 percent of patients in the topical group had severe pain versus 5 percent of patients in the retrobulbar group. The second article (Nielsen and Allerod, 1998) (130 subjects, quality score 59) compared retrobulbar, subconjunctival/sub-Tenon's, and topical anesthesia in subjects undergoing bilateral simultaneous cataract extraction: 79 percent receiving retrobulbar block reported no pain, while only 44 percent receiving topical anesthesia did so.
The last two studies reported 91 percent of patients had no pain during surgery after retrobulbar block compared to 83 percent with topical anesthesia (Patel, Burns, Crandall et al., 1996) (138 subjects, quality score 52) and 89 percent of patients had no pain during surgery after retrobulbar block versus 69 percent with topical anesthesia (Patel, Clinch, Burns et al., 1998) (90 subjects, quality score 49).
Conclusion: Retrobulbar block results in less pain during cataract surgery than topical anesthesia. [Evidence Grade: A]
Three of the five studies directly addressing this question found that peribulbar block resulted in less pain during surgery than topical anesthesia. One study (Johnston, Whitefield, Giralt et al., 1998) (82 subjects, quality score 26) reported that the median pain score was 2 out of 10 with topical anesthesia versus 0 with peribulbar block. The second article (Uusitalo, Maunuksela, Paloheimo et al., 1999) (299 subjects, quality score 58) reported that 93 percent of patients had no pain and none had severe pain in the peribulbar group, as opposed to 70 percent of patients with no pain and 4 percent with severe pain in the topical group. The third study (Virtanen and Huha, 1998) (100 subjects, quality score 45) used a scleral tunnel technique and found that 76 percent of patients had no pain and none had severe pain in the peribulbar group, while only 12 percent of patients had no pain and 2 percent had severe pain in the topical group.
The two articles that reported similar results in the two groups assigned individuals to receive topical anesthesia in one eye and peribulbar block in the other eye. One article (Roman, Auclin, and Ullern, 1996) (90 subjects, quality score 36) reported similarly high percentages with no pain (96 percent in the peribulbar group versus 93 percent in the topical group), but patients all received intravenous sedation/anesthesia. The second study (Zehetmayer, Radax, Skorpik et al., 1996) (72 subjects, quality score 54) reported identical mean scores with both approaches.
Conclusion: Peribulbar block results in less pain during cataract surgery than topical anesthesia. [Evidence Grade: B]
Three studies addressed this question directly. The first study that directly addressed this question (Fukasaku and Marron, 1994) (348 subjects, quality score 11) compared two different subconjunctival/sub-Tenon's blocks to two different approaches to topical anesthesia. In one arm, more pain during surgery was reported by patients receiving subconjunctival/sub-Tenon's anesthesia (85 percent with no pain and 2 percent with severe pain). In the two topical arms, 78 percent of patients (using a soaked pledget) and 69 percent (using drops alone) had complete absence of pain during cataract surgery, and none had severe pain. The second article (Nielsen and Allerod, 1998) (130 subjects, quality score 59) compared retrobulbar, sub-Tenon's, and topical anesthesia in subjects undergoing bilateral, simultaneous cataract extraction. Sixty-four percent receiving subconjunctival/sub-Tenon's block reported no pain, while only 44 percent receiving topical anesthesia did so. The final study reported a mean pain score of 0.4 using topical versus 0.02 with subconjunctival/sub-Tenon's (Manners and Burton, 1996).
Conclusion: The data indicate that subconjunctival/sub-Tenon's block results in less pain during cataract surgery than topical anesthesia. [Evidence Grade: C]
All four randomized clinical trials evaluating the effectiveness of adding intracameral lidocaine to topical anesthesia found that intracameral lidocaine improves pain control during cataract surgery (Carino, Slomovic, Chung et al., 1998; Crandall, Zabriskie, Patel et al., 1999; Gills, Cherchio, and Raanan, 1997; Tseng and Chen, 1998). One of these (using no routine sedation) found only slight overall improvement in pain control but reported that patients complained less of tissue manipulation with the use of intracameral lidocaine (Crandall, Zabriskie, Patel et al., 1999). Two of the remaining three articles used no sedation and found intracameral lidocaine decreased patient-reported pain. No pain was experienced by 77 percent in the intracameral group versus 47 percent in the control in one study (Carino, Slomovic, Chung et al., 1998), and 90 percent versus 74 percent in the other (Gills, Cherchio, and Raanan, 1997). The final article reported on patients receiving oral sedation prior to surgery. Patients reported no pain in 67 percent of the intracameral group versus 49 percent of the controls (Tseng and Chen, 1998). This study also reported that tissue manipulation (particularly touching the iris) was more uncomfortable without intracameral lidocaine.
Conclusion: Studies consistently demonstrated better pain control during surgery using intracameral lidocaine. [Evidence Grade: B]
One article (House, Hollands, and Schulzer, 1991) reported that 100 percent of subjects experienced no pain during surgery in six of seven arms of a study looking at various combinations of anesthetic agents. Only one patient in the final arm (which was one of the two arms that did not use hyaluronidase) experienced any pain.
Conclusion: There is insufficient evidence in the literature to address this question. [Evidence Grade: I]
Six studies directly addressed this question and reported abstractable data. Four studies examined lidocaine and bupivacaine in at least one arm. One study (Dopfmer, Maloney, Gaynor et al., 1996) (90 subjects, quality score 43) compared lidocaine 2 percent and bupivacaine 0.75 percent to prilocaine 3 percent for peribulbar anesthesia and found a slightly higher rate of pain control with prilocaine (98 percent of patients with no pain) than with the combination of lidocaine and bupivacaine (93 percent of patients with no pain). Another study (Henderson and Franks, 1996) (75 subjects, quality score 37) only reported the mean pain score (0-10 scale) with prilocaine 2 percent versus bupivacaine and lidocaine and found very similar scores (1.2 and 0.9, respectively). One study (Loots, Koorts, and Venter, 1993) (151 subjects, quality score 45) compared bupivacaine to a combination with lidocaine and found 100 percent of patients had complete pain control in all groups. The third study (House, Hollands, and Schulzer, 1991) (117 subjects, quality score 51) compared various combinations of bupivacaine, lidocaine, hyaluronidase, and epinephrine and found that eight of nine groups had complete pain control in all patients, with the final group having only one individual with less than perfect pain control during surgery.
One study (Huha, Ala-Kokko, Salomaki et al., 1999) (100 subjects, quality score 60) compared ropivacaine 1 percent to bupivacaine 0.75 percent. Eighty-eight percent of patients in both groups experienced no pain during the surgery.
The final study (Gutman, Sinskey, and Cain, 1979) (52 subjects, quality score 34) reported 93 percent of patients had no pain during surgery and none had severe pain with lidocaine, as opposed to 100 percent of patients having no pain during surgery with etidocaine.
Conclusion: All agents reported had high rates of excellent pain control during surgery. There are insufficient data in the literature to determine if these agents are truly equivalent in controlling pain during surgery. [Evidence Grade: I]
Three studies directly addressed this question. One study (Bell and Butt, 1995) (60 surgeries, quality score 36) reported only on the percentage experiencing no pain during the block. Three percent of patients receiving warmed anesthetic, as opposed to no patients with room-temperature anesthetic, reported no pain during the block. The second study (Ursell and Spalton, 1996) (40 subjects, quality score 49) reported lower mean pain scores (0-10 scale) during the injection with warming of the anesthetic than without warming (3.6 versus 5.3).
The final study (Krause, Weindler, and Ruprecht, 1997) (70 subjects, quality score 42) reported higher rates of complete akinesia with than without warming of lidocaine (77 percent versus 60 percent).
Conclusion: There is insufficient and inconclusive data to determine if warming of anesthetic agents improves their performance during cataract surgery. [Evidence Grade: I]
Three studies assessed directly the effects of pH adjustment on block effectiveness. One study (Lewis, Hamilton, Brant et al., 1992) reported only the percentage of patients with poor akinesia: 35 percent in the pH 5.4 group and 25 percent in the pH 6.8 group. Another study (Zehetmayer, Rainer, Turnheim et al., 1997) reported only the mean pain score (0-10 scale) during surgery, which was 0.98 in the pH 7.2 group and 1.0 in the pH 5.2 group. A third study (Hinshaw, Fiscella, and Sugar, 1995) reported only the mean pain of the block administration itself, 6.0 for the pH 6.7 group and 8.2 for the pH 6.04 group (0-10 scale).
Conclusion: pH adjustment of the anesthesia agent used in a local block has no effect on the block's effectiveness. [Evidence Grade: C]
[Note: Studies (groups) where the technique was a combination of peribulbar and retrobulbar blocks are listed twice, once under each block type]. The range of values for the frequency of the major ocular and systemic complications is presented in these tables. However, complications were rarely and not systematically presented in the literature. The most important ocular complications (e.g., globe perforation) are sufficiently rare in incidence that the reported frequency in a given study is almost invariably zero. The situation is analogous for significant medical complications (e.g., stroke). Furthermore, the definitions used for many of the complications reported (e.g., ptosis) are so variable that it is difficult to compare rates of complications across studies.
In order to assess the complications associated with different approaches to local anesthesia, we reviewed all case series with 1,000 or more cases. By far the largest series presented consisted of 12,000 cases (Hamilton, Gimbel, and Strunin, 1988), about half of whom received retrobulbar blocks and half of whom received peribulbar blocks. There were 8 cases of brainstem anesthesia with respiratory arrest in 5,235 retrobulbar block cases (0.15 percent). An additional five patients had central nervous system (CNS) abnormalities without respiratory arrest. No cases of CNS block were reported in 5,704 peribulbar injections. Data on retrobulbar hemorrhage were reported only for one of the two retrobulbar block groups, with 5 cases of "moderate" hemorrhage out of 3,595 retrobulbar block cases (0.14 percent). Only one case of scleral perforation was reported in the 5,235 retrobulbar patients, and none occurred in the peribulbar groups.
Another study reported no cases of scleral perforation in over 4,000 operations using either retrobulbar or peribulbar techniques (Waller, Taboada, and O'Connor, 1993). One study of 1,600 cases of peribulbar injections reported no cases of scleral perforation, brainstem anesthesia, or retrobulbar hemorrhage (Davis and Mandel, 1986). Hendrick, Rosenberg, and Lebenbom-Mansour (1997) reported no cases of scleral perforation, brainstem anesthesia, or retrobulbar hemorrhage using peribulbar blocks in 1,074 cases.
In summary, large case series indicate that severe complications are rare with peribulbar and retrobulbar block. The major risk factor for scleral perforation is the axial length of the eye, longer eyes having greater risk.
One study reported on the complication rates when using topical anesthesia in combination with a lid block (Hodgkins, Teye-Botchway, Morrell et al., 1992). The authors reported one case of expulsive choroidal hemorrhage in 1,817 cases.
No severe complications were reported with subconjunctival/sub-Tenon's anesthesia, although conjunctival chemosis and subconjunctival hemorrhage are common.
The following section summarizes the evidence regarding sedation strategies, using the same reporting approach used for the section on local anesthesia. Synthesis of the evidence in this section was significantly limited by the heterogeneity in and lack of standardization of the outcomes reported.
Three studies directly addressed this question. Wong and Merrick (1996) (120 subjects, quality score 86) randomized cataract surgery patients to placebo, intravenous benzodiazepines, intravenous opiates, or a combination of benzodiazepines and opiates. Intravenous sedation/anesthesia was associated with a larger percentage of patients reporting excellent satisfaction (100 percent versus 93 percent) and a small reduction in recall of pain during the block (median pain scores 0.6, 0.9, and 1.2 in the groups receiving sedation and/or anesthesia versus 1.4, in the group receiving placebo, 0-10 scale), although the differences for both outcome measures were marginal. Pac-Soo, Deacock, Lockwood et al. (1996) performed a randomized clinical trial (49 subjects, overall quality score 77) and evaluated patient-controlled analgesia with midazolam or propofol versus no patient-controlled analgesia. Intravenous sedation/anesthesia was associated with reduced anxiety (0.5 versus 1.5, p < 0.05, 0-10 scale). There were no differences in blood pressure between the nonsedated and the sedated group. One study evaluated intramuscular analgesia compared to placebo (Virkkila, Ali-Melkkila, and Kanto, 1992) (90 subjects, overall quality score 76). Intramuscular opiates (mean score 3.5) were superior to intramuscular midazolam (mean score 4.5) and placebo (mean score 5.4) regarding reduction in pain during the block. Intramuscular analgesia or sedation was associated with increased bradycardia, and less intraoperative anxiety compared to no intramuscular agent.
Conclusion: Intravenous or intramuscular sedation/analgesia is associated with a modest improvement in anxiety, pain relief, and patient satisfaction. [Evidence Grade: C]
Other studies that provide some information about the effectiveness of oral or intramuscular sedation in cataract surgery are summarized in Evidence Tables 43, 44, and 45. Evidence Table 43 summarizes the data on patient cooperation and pain. Evidence Table 44 summarizes the data on patient anxiety and satisfaction, and Evidence Table 45 summarizes the data on medical outcomes and hemodynamics. The primary aim of these studies was not to compare different sedation strategies, but they provide data on patients who received only oral or intramuscular sedation. A total of 22 studies included only oral sedation. Several studies with oral sedation reported pain scores. Boezaart, Berry, Laubscher et al. (1998) used oral sedation and reported mean scores for pain during the block of 1.95 to 2.52 (on a 0 to 10 scale), depending on regional technique. Zehetmayer, Radax, Skorpik et al. (1996) and Zehetmayer, Rainer, Turnheim et al. (1997) reported mean pain scores from 0.1 to 1.1 (on a 0 to 10 scale) in two studies employing oral analgesia.
Only one study reported on patient anxiety. Oikkonen (1994) reported that 20 percent of patients reported no anxiety during the case with oral sedation alone. None of the studies reported on patient satisfaction. Ali-Melkkila, Virkkila, Leino et al. (1993) reported on the percent of patients who would desire the same management again; 99 percent of patients said they would choose oral sedation again. Jolliffe, Abdel-Khalek, and Norton (1997) reported that approximately 87 percent of patients desired the same oral sedation management strategy again. Only one study that employed oral sedation reported any medical complications. Saunders, Sturgess, Pemberton et al. (1993) reported that 2 percent of patients developed postoperative congestive heart failure. No study reported any hemodynamic complications. The need for supplemental intravenous analgesics was reported in several studies. Ali-Melkkila, Virkkila, Leino et al. (1993) reported that 3 percent of patients receiving oral sedation with lorazepam required supplemental fentanyl. Sarvela (1993) reported a 4-percent incidence of requiring supplemental fentanyl.
A total of six studies employed intramuscular sedation. Virkkila, Ali-Melkkila, and Kanto (1992) reported mean pain scores during the block of 3.5 to 5.4 on a 0 to 10 scale. No study using intramuscular sedation evaluated anxiety, patient satisfaction, or the percentage of patients desiring the same management strategy. No medical complications were evaluated in any study using intramuscular sedation. Hemodynamics were evaluated in the study by Virkkila, Ali-Melkkila, and Kanto (1992). Intramuscular analgesia was only associated with bradycardia and no other complications. Approximately 5 percent of patients required supplemental analgesia in two of the studies.
In summary, oral and intramuscular sedation are associated with moderate pain during the block, little pain during surgery, and a small requirement for supplemental intravenous sedation.
Evidence Table 46 summarizes data on patient cooperation and pain. Evidence Table 47 summarizes the data on patient anxiety, and Evidence Table 48 summarizes the data on medical outcomes and hemodynamics. Studies were separated according to class of agent.
Eight studies assessed benzodiazepines. Two of these studies assessed pain during surgery (Anderson, 1995; Anderson, Nath, and Anderson, 1999), reporting that 90 percent and 88 percent of patients had no pain during surgery. Only one study (Wong and Merrick, 1996) reported on patient satisfaction, and all patients were satisfied with the anesthesia management. No medical complications were reported in any of these studies, and the only hemodynamic complication was bradycardia (3 percent) (Virkkila, Ali-Melkkila, and Kanto, 1992). There was a rare need for supplemental oxygen in 1.7 percent of patients. In the study by Anderson (1995), 1 percent of patients required supplemental intravenous sedation.
In three studies, barbiturates were evaluated. In one study (Patel, Burns, Crandall et al., 1996), the percentage with no pain during the block was reported at 96 percent and no pain during surgery was reported in 9 percent of patients. Overall mean pain scores during the block were extremely low. Anxiety and patient satisfaction were not reported in these studies. No medical or hemodynamic complications were reported. Supplemental analgesics were required in 1 percent of patients in the study by Patel, Burns, Crandall et al. (1996).
Analgesics were used as the only class of sedative agent in at least one group in nine studies. Pappa, Pouliou, Nastou et al. (1995) reported that 50 percent of patients had severe pain using retrobulbar regional anesthesia alone without topical EMLA. The mean pain score (on a 0 to 10 scale) during the block was 3.0 in this group compared to 1.85 when EMLA was placed on the skin before the injection. No other study directly assessed pain. Uusitalo, Maunuksela, Paloheimo et al. (1999) reported on patient satisfaction, with 5 percent of patients receiving intravenous sedation/anesthesia having fair to poor satisfaction with the anesthesia received. No medical or hemodynamic complications were reported from any of these studies.
Three studies reported on the use of propofol alone. Only one study (Gillart, Bazin, Montetagaud et al., 1998) reported the percentage of patients who had no pain during the block, which was approximately 48 percent overall. There were no major medical complications, and supplemental oxygen was rarely needed.
Propofol was included as part of the sedation/anesthesia regimen in three studies. Kost and Emerson (1992) evaluated patient satisfaction with a combined analgesic/propofol regimen, with only 30 percent reporting very good to excellent satisfaction. The need for supplemental oxygen was the only medical or hemodynamic complication that was reported in any of these studies; it occurred in 4 percent to 40 percent of patients.
The combination of benzodiazepine and analgesic in the two studies by Patel, Burns, Crandall et al. (1996) and Patel, Clinch, Burns et al. (1998) (138 subjects, quality score 52; 90 subjects, quality score 49) demonstrated that only 60 percent to 70 percent of patients had no pain during the block and during surgery. Only 3 percent of patients receiving this combination reported excellent satisfaction in the study by Kost and Emerson (1992) (74 subjects, quality score 48).
In summary, no one class of agent or combination of agents appears superior to another for sedation.
A total of 12 randomized clinical trials directly compared one class of intravenous sedative/anesthetic to another class or a combination of classes. Three studies directly addressed the comparison of benzodiazepines against another class of drug. Pac-Soo, Deacock, Lockwood et al. (1996) (49 subjects, quality score 63) compared benzodiazepines with propofol and found that surgeons reported greater patient cooperation and less need for supplemental oxygen in the propofol group. Virkkila, Ali-Melkkila, and Kanto (1992) (49 subjects, quality score 63) compared benzodiazepines to analgesics and reported lower pain scores during the block in the analgesic group (mean 3.5 versus 4.5, p < 0.001 on a scale from 0 to 10) without increased need for supplemental oxygen. Wong and Merrick (1996) (90 subjects, quality score 76) also compared benzodiazepines to analgesics and reported an increased need for supplemental oxygen in the analgesic group.
Two studies by Patel, Burns, Crandall et al. (1996) and Patel, Clinch, Burns et al. (1998) compared barbiturates to combinations of benzodiazepines and analgesics. Both studies demonstrated that a greater percentage of patients in the barbiturate group reported no pain during both the block and surgery.
A group containing propofol alone was included in three studies, with an additional three studies including a combined propofol/analgesic group. Kost and Emerson (1992) reported higher patient satisfaction in the propofol and analgesic group compared to the benzodiazepine and analgesic group. The study by Yee, Burns, Mann et al. (1996) (30 subjects, quality score 44) was the only study in which a higher incidence of need for supplemental oxygen was reported with propofol compared to propofol and analgesics.
The remaining studies compared combinations of sedative and analgesic medications in single or escalating dosages. Gilbert, Holt, Johnston et al. (1987) (55 subjects, quality score 67) reported greater patient satisfaction with a combination of barbiturate and analgesic compared to a combination of benzodiazepine and analgesic (74 percent versus 43 percent, p < 0.019).
Conclusion: There is insufficient evidence to suggest that one analgesic regimen is superior to another. [Evidence Grade: I]
Two studies directly assessed the value of intravenous patient-controlled analgesia and sedation. Herrick, Gelb, Nichols et al. (1996) (55 subjects, quality score 61) evaluated the effectiveness of intravenous patient-controlled propofol versus placebo. Patients demonstrated marginally improved satisfaction with patient-controlled propofol, with only a minor increase in the need for supplemental oxygen. Pac-Soo, Deacock, Lockwood et al. (1996) compared patient-controlled sedation with placebo, midazolam, and propofol (49 subjects, quality score 63). They demonstrated reduced anxiety, with only a mild increase in the need for supplemental oxygen in the groups receiving intravenous medications. Both of the studies employed small cohorts of patients. Patient-controlled sedation is not a common approach and may not be generalizable to other clinical scenarios.
Conclusions: There is evidence to suggest that patient-controlled analgesia is an effective method of supplying intravenous sedation, but there is also evidence suggesting an increased need for supplemental oxygen. [Evidence Grade: C]
There is insufficient evidence to assess patient-controlled analgesia in comparison to other common methods of delivering sedation. [Evidence Grade: I]
The following discussion is organized around the strength of the evidence found in the literature for the key clinical questions that were identified. Issues relating to local anesthesia are presented first, followed by those relevant to systemic sedation.
The most thoroughly studied issue in the literature was the relative effectiveness of retrobulbar block and peribulbar block anesthesia. The evidence indicated that peribulbar and retrobulbar anesthesia produce equally good akinesia and equivalent pain control during cataract surgery. Comparative studies consistently found no differences between the two techniques. However, results reported in the many published case series using these two techniques varied tremendously. This is likely attributable to the fact that block techniques and sedating agents were not the same from study to study, surgical approaches and surgical times varied, and the measurement of outcomes was not standardized. Any or all of these may have contributed to the wide range of reported effectiveness of these two techniques in the uncontrolled studies. Sedation strategies may have influenced the results as well.
The literature also provided strong evidence that retrobulbar block is more painful upon injection than topical drops. Only in the presence of heavy sedation were these two approaches equally painless.
The pain felt upon administration of subconjunctival/sub-Tenon's blocks was less than that for retrobulbar block. While the differences were not large, and only mean pain scores were usually reported, the overall evidence was consistent and favored subconjunctival/sub-Tenon's block. In addition, the same three articles that reported less pain on administration of subconjunctival/sub-Tenon's block also found that pain during cataract surgery was less with subconjunctival/sub-Tenon's block than with retrobulbar block. While the number of studies involved was not large, the results were fairly consistent.
There was insufficient evidence in the literature to make any statements about the relative effectiveness of subconjunctival/sub-Tenon's block at producing akinesia when compared with peribulbar block or retrobulbar block. Only one study (nonrandomized) found similar pain control with subconjunctival/sub-Tenon's as with peribulbar block. However, as stated above, there was moderate evidence that subconjunctival/sub-Tenon's block produced better pain control than retrobulbar block. There was weak evidence that subconjunctival/sub-Tenon's block was less painful on application than peribulbar block. Finally, there was weak evidence that subconjunctival/sub-Tenon's block produces better pain control than topical anesthesia.
There was only weak evidence supporting different agents, and this was based largely on single trials. Etidocaine, mepivicaine, and bupivacaine all appeared to produce similar akinesia. Bupivacaine alone appeared to be as effective at producing akinesia as bupivacaine and lidocaine together. There was insufficient evidence to reach firm conclusions on the relative merits of one agent over another at producing pain control.
While several studies compared hyaluronidase with placebo, few reported data on the effect of using hyaluronidase on pain control. On average, hyaluronidase appeared to produce better akinesia than placebo, but the results of studies addressing this issue were inconsistent, with several studies finding no benefit. In addition, hyaluronidase consistently took 2 to 3 minutes less to produce akinesia than in the control group, where hyaluronidase was not used, but the difference was not always statistically significant.
Other approaches were attempted to improve the effectiveness of different block techniques. Three studies warmed the agents prior to the block, with little difference seen. The evidence is insufficient to comment on the relative benefit of this technique. Three studies also looked at increasing the pH of anesthetic agents in an effort to decrease the pain of the block and increase the effectiveness. The evidence from these studies is insufficient to draw conclusions.
The evidence suggests that the addition of intracameral nonpreserved lidocaine to topical anesthesia increases the pain control of this technique. The evidence also suggests that adequate pain control can be achieved in a high percentage of cataract surgical patients undergoing surgery with topical anesthesia, with or without the intracameral injection of an anesthetic agent. However, it appears that the degree of pain control with this technique is still less than with any of the block techniques. Surgeon-related factors, such as the time necessary to complete the surgery, may well be important variables in the success of topical anesthesia. However, surgical time was rarely reported.
We had hoped that the literature would provide useful information on the safety and effectiveness of alternative local anesthetic techniques relative to the professional training of the individual administering the local anesthesia, the setting of care, and the monitoring used. However, such information was rarely collected or presented by authors. Only 20 percent of the reported studies gave any information on surgical time, and surgical time was virtually always reported only as a mean value. Clearly, surgical time and the effectiveness of anesthesia as reported by patients are likely to be correlated. This methodologic problem, in addition to the others previously described, limits the inferences one can draw from much of the literature.
It is clear that a variety of techniques for local anesthesia (i.e., peribulbar, retrobulbar, subconjunctival/sub-Tenon's injection, and topical anesthesia) are highly safe and effective for the intraoperative management of cataract surgery. However, it is difficult, based on the published literature, to compare in a meaningful way the rates of ocular or systemic complications associated with different strategies for local anesthesia. For example, it is self-evident that ocular perforation does not occur with topical anesthesia or with sub-Tenon's anesthesia delivered with a blunt cannula, while perforation is a risk for any technique involving a needle. However, the rates of ocular perforation are sufficiently low (between 1 in 1,000 and 1 in 10,000 cases) that the outcome is rarely addressed directly. Other important outcomes, such as posterior capsular rupture, retrobulbar hemorrhage, and bradycardia, were also difficult to compare across techniques. This is not only because of their relative rarity, but perhaps more importantly, because of the wide variation in outcome definitions, surgical populations, and surgical techniques. Regarding the surgeon, many of the studies relied on the experience of individual surgeons (rather than on groups of surgeons using a standardized technique), thereby placing the representativeness of the reported data in question.
The evidence available from the literature and from the Study of Medical Testing for Cataract Surgery (see the section "Supplemental Analysis") is consistent regarding the use of topical versus injection anesthesia. Specifically, both sources indicate that while reported pain control is very good with both techniques, the rate of complete pain control is superior with injection techniques. However, intraoperative pain control is not the only consideration underlying choice or recommendation for anesthesia technique. Additional considerations might include, for example, patient anxiety, patient preferences for complications/side effects of one choice versus the other, discomfort on administration, need for supplemental intravenous sedation, and cost. Except for reporting on pain, the currently available literature is largely limited in its incorporation of the patient perspective into anesthesia strategy choice.
With regard to sedation strategies, there are no specific questions for which there is sufficient evidence to justify a strong or moderate rating of the strength of evidence.
Three studies directly compared intravenous or intramuscular sedation/anesthesia to local anesthesia alone using a placebo-controlled design. All showed a general trend toward improved patient-oriented outcomes (improved anxiety, pain relief, and patient satisfaction) with intravenous or intramuscular sedation. However, the total sample sizes were small and there were no differences in actual morbidity.
There was insufficient evidence to determine if any one class of sedative/anesthetic agent was associated with improved outcome compared to another class.
Major morbidity was not reported in any trial. All of the studies were small and used different outcome measures. Many of the studies used combinations of agents rather than comparing a single sedative/anesthetic agent. Additionally, the type of local anesthesia technique differed between studies. Further research is required that uses a standard local anesthesia protocol and standard endpoints to better define the optimal sedative strategy.
In summary, the published literature on sedation/anesthesia strategies for cataract surgery is not comprehensive. Most importantly, the literature is limited by (1) a lack of standardization of definition of the principal outcomes of interest and (2) a lack of evidence addressing the fundamental question of whether systemic sedation is associated with improved patient outcomes.
Based on our findings, we hope that future research will pay more detailed attention to important methodologic considerations. Although the relative importance of specific recommendations in this area depends on the precise question being addressed, we suggest that greater attention be devoted to (1) ensuring the representativeness of the study population (e.g., consecutive patients or the use of a specified sampling frame, and the use of data from multiple surgeons); (2) the specification of study exclusions, if any; (3) the preoperative medical and ophthalmic characteristics of the study population; (4) the description of the surgical technique, including both the mean and distribution of surgery times; (5) the use of outcomes that have been clearly defined; and 6) the actual distribution (rather than just means) of patient reports of pain, satisfaction, etc.
We identified two significant gaps in the content of literature. First, there is insufficient incorporation of patient perceptions of and preferences for different anesthesia and sedation techniques. Relevant patient perspectives that might be addressed in the same randomized study might include not only pain but also anxiety, drowsiness, and nausea. Learning patient preferences for specific tradeoffs (e.g., greater awareness of surgery with topical anesthesia versus more rapid recovery of vision) would be very valuable in trying to assess optimal or preferred strategies for both local anesthesia and sedation.
The second major gap relates to the cost effectiveness of different management strategies. The most obvious example relates to the use of intravenous sedation with associated monitoring by an anesthesiologist. Almost no research directly addressed the value of anesthesiologists/nurse anesthetists and intravenous sedation during cataract surgery. One article reviewed (Pecka and Dexter, 1997) and another published after the close of our review process (Rosenfeld, Litinsky, Snyder et al., 1999) claim a benefit to the presence of an anesthesia professional based on the frequency of reported intraoperative interventions (e.g., the administration of an antihypertensive). However, these reports used no control groups and did not show any actual benefit to patient health. Furthermore, preliminary data from the Study of Medical Testing for Cataract Surgery suggest that the use of intravenous agents is associated with higher rates of intraoperative adverse medical events (e.g., treatment for hypertension or arrhythmia) than when such agents are not used. In light of the significant costs associated with monitored anesthesia care, uncertainty regarding the existence or magnitude of its benefit to patients, the value that patients place on the services, and the significant national and international variation in the use of intravenous sedation and monitoring by an anesthesia professional, we believe that this is an important area for future study.
Review of the available evidence showed no explicit comparisons of the risks, benefits, and costs of different models of anesthesia care for cataract surgery (e.g., topical versus regional block and oral versus intravenous sedation). Additionally, practice patterns used both nationally and internationally for the provision of intravenous sedation/anesthesia have not been evaluated in any prospective fashion. In the absence of explicit data, a decision analysis was constructed to explore the potential cost effectiveness of different models of anesthesia care. Decision analysis is an analytic tool designed to facilitate complex clinical, therapeutic, or diagnostic decisions in which many variables must be considered simultaneously. The analysis performed here is an attempt to assess the economic impact, as well as the benefits and risks to the patient, of different anesthesia management strategies for cataract surgery as an exploratory process to guide future research. We chose to examine anesthesia strategies that are prevalent internationally. A manuscript describing this work (Reeves, Fleisher, Friedman et al.) is now in preparation for print.
To perform the decision analysis, we: (1) identified the problem and defined alternative courses of action; (2) constructed a decision tree; (3) gathered relevant information to fill the tree; (4) performed calculations to analyze the tree in order to determine the optimum strategy; and (5) performed sensitivity analyses to assess the stability of the analysis to the assumptions (Petitti, 1994). Sensitivity analysis is an explicit means of assessing the robustness of our conclusions to uncertainty in the values used in our model.
The decision model for the analysis was developed in DATA 3.5 (Treeage Software, Boston, Massachusetts). The authors of this report developed the scenarios by an interactive process in collaboration with external consultants. Baseline scenarios included local block (either retrobulbar or peribulbar block) or topical anesthesia (including intracameral anesthesia). For both the block and topical anesthesia alternatives, sedation strategies of intravenous and oral medications were included. Finally, strategies with an anesthesiologist in the operating room, "on call," or "not present and unavailable" were assessed. In the scenarios, an "on call anesthesiologist" referred to an anesthesiologist present in the operating suite and immediately available to provide sedation/monitoring/resuscitation but not specifically assigned to be present in the operating room during the procedure. For the sake of simplicity, an anesthesiologist was defined as the provider of anesthesia care. There are multiple potential models of anesthesia care, including an anesthesiologist, an anesthesiologist/certified registered nurse anesthetist (CRNA) care team, or a CRNA working under the medical direction of the ophthalmologist. These were not separately assessed. A total of six clinically relevant strategies were chosen:
Strategy 1: Intravenous (IV) sedation administered by an anesthesiologist and block (retrobulbar or peribulbar) anesthesia intraoperatively, with an anesthesiologist present in the operating room throughout the procedure.
Strategy 2: Oral sedation preoperatively and block anesthesia intraoperatively, with an anesthesiologist on call for additional sedation if needed.
Strategy 3: Oral sedation preoperatively and block anesthesia intraoperatively, with no anesthesiologist on call for additional sedation.
Strategy 4: Intravenous sedation administered by an anesthesiologist and topical anesthesia intraoperatively, with an anesthesiologist in the room for monitoring and for additional sedation.
Strategy 5: Oral sedation preoperatively and topical anesthesia intraoperatively, with an anesthesiologist on call for additional sedation.
Strategy 6: Oral sedation preoperatively and topical anesthesia intraoperatively, with no anesthesiologist on call for additional sedation.
For each general strategy, potential outcomes of the anesthesia strategy included no complications, conversion to general anesthesia, or conversion from topical anesthesia to an ocular block by injection. Adverse events included in the model were complications requiring admission within one week, cardiovascular instability intraoperatively, or nausea and vomiting postoperatively. Probabilities for possible outcomes were assigned based upon the available literature. If no data were available in the literature, then data from the Study of Medical Testing for Cataract Surgery (SMTCS) were used. If information was still unavailable on the probabilities of different outcomes, a group of eight clinical experts, including anesthesiologists, ophthalmologists, and internists, were asked to assign probabilities based on clinical judgment. Risks of rare major complications, such as total spinal anesthesia related to performance of a retrobulbar injection and death, were not included in the model since the rates of these complications for the different baseline anesthesia strategies could not be estimated from any available sources and are extremely low.
Preference values for the six anesthesia management strategies were determined based upon the responses of 10 health care providers, including anesthesiologists, nurse anesthetists, ophthalmologists, and internists. The experts were asked to rate the anesthesia strategies described above using a score from 0 to 100, with 0 representing the worst possible experience during cataract surgery and 100 representing the ideal experience. The highest and lowest responses were used to determine a plausible range in the sensitivity analysis. The decrease in preference value (i.e., disutility factor) due to a complication was determined by asking the experts to assign preference values to anesthesia management scenarios that included a complication. We calculated a disutility factor for each complication by dividing the preference value assigned to the strategy with the complication by the preference value assigned to the scenario without the complication. The plausible range for the disutility factor was based on the lowest and highest values assigned by individual experts. Importantly, the preference values and disutility factors used for this analysis do not represent traditional utilities, in that perfect health and death were not the anchors. However, it would not have been possible to differentiate adequately among the anesthesia strategies if we had used perfect health and death as the anchors for assigning preference values to the strategies.
Cost estimates are best based on a single payer's perspective. For the case of sedation during cataract surgery, the primary payer is Medicare. However, Medicare pays a capitated fee for services based on diagnosis-related groups (DRGs), making it difficult to evaluate the true cost of different anesthesia management strategies. DRG fees are based on the average cost of the typical approach being used by physicians and hospitals. Because the adoption by physicians and hospitals of more expensive approaches will ultimately lead to increases in the DRG fees, we used the provider's perspective in calculating costs. Ultimately, incremental costs incurred by more expensive management strategies may be reflected in what Medicare pays for anesthesia care.
The costs used in the model were based on costs from The Johns Hopkins Hospital and the average wholesale price for drugs. Since there are administrative costs for the use of pharmaceutical agents during anesthesia, we used twice the average wholesale price to estimate these added costs.
The cost of the anesthesia provider was based upon the current prevailing rate of a per diem anesthesiologist of $1,000 per day with an average work day of 10 hours, attending approximately 10 cataract surgeries. Therefore, the baseline cost was $100 and varied from $75 to $150. There are no data to estimate the cost of having one anesthesiologist immediately available for emergencies but not specifically assigned to an anesthesia case (on call) since this is currently not a reimbursable model used by the Health Care Financing Administration. As a means of estimating these costs, we developed a theoretical model assuming a maximum coverage ratio for a single-center cataract anesthesia site with one anesthesiologist present. Since an average site would have four rooms, we assumed that the average anesthesiologist cost would be $25 per surgery (one-fourth of the above estimate of $100 per surgery for having an anesthesiologist present throughout the case). We estimated a maximum coverage of eight rooms and varied the costs from $9.30 ($75 divided by eight rooms) to $37.50 ($150 divided by four rooms).
As described previously, for calculations, we assumed an anesthesiologist was the provider of anesthesia care, although multiple models of anesthesia care from a personnel standpoint are possible. Since the Health Care Financing Administration currently reimburses these models similarly, we performed a sensitivity analysis around the cost of the anesthesiologist in an attempt to define these variable costs and incorporate the potential costs of these alternative staffing models.
The cost of anesthesia supplies was based upon the hospital anesthesia supply fee at The Johns Hopkins Hospital multiplied by the Medicare cost-to-charge ratio. The cost of preoperative testing was the charge associated with the average number and type of tests used in the Study of Medical Testing for Cataract Surgery, converting hospital charges to costs using the Medicare cost-to-charge ratio. The costs of all of the drugs were based upon the most commonly administered medications for an average 45-minute case using the methodology noted above.
Several assumptions were made in designing the final decision tree (Appendix P). We assumed that conversion to general anesthesia is a rare enough event to be mutually exclusive of conversion to block anesthesia from topical anesthesia. Also, we assumed that complications which would require admission postoperatively are mutually exclusive of uncomplicated intraoperative cardiovascular instability and nausea and vomiting postoperatively. We assumed that the decrease in preference value (e.g., disutility) associated with the complication of being converted to general anesthesia would be the same for strategies 1, 2, and 3 (block anesthesia with different sedation strategies). Likewise, we assumed that the disutility associated with the complication of being converted to block from an initial choice of topical anesthesia would be the same for strategies 4, 5, and 6 (topical anesthesia with different sedation strategies). We assumed that the disutilities associated with the complications of postoperative admission, postoperative nausea and vomiting, and intraoperative cardiovascular instability would be the same for all six anesthesia strategies.
When considering the probability of conversion to general anesthesia, the probability of conversion for patients receiving intravenous sedation and block was assumed to be the same as for patients receiving intravenous sedation and topical anesthesia, and the probability of conversion for patients receiving oral sedation and block was assumed to be the same for patients receiving oral sedation and topical anesthesia. Lastly, when considering the probability of conversion to block after initially receiving topical anesthesia, the probability of conversion was assumed to be the same for those patients receiving intravenous sedation and those receiving oral sedation.
The probabilities, patient preference values, and costs assigned to the tree are shown in Decision Analysis Tables 1 through 3 (Appendix Q). The tree is shown in Appendix P.
The probabilities and estimated costs were inserted into the tree, and the expected cost was computed for each management strategy. The strategy of least expected cost was found to be strategy 3, block anesthesia with oral sedation preoperatively, with no anesthesiologist/nurse anesthetist present in the operating room (OR) or on call (Decision Analysis Table 4). This strategy was only marginally less costly than strategy 6, topical anesthesia with oral sedation preoperatively, with no anesthesiologist available ($17.16 versus $17.46).
One-way sensitivity analysis of the expected costs was performed. The cost and probability of each variable were varied across its entire plausible range while all other variables were held constant. For a particular variable to be "sensitive" in a one-way sensitivity analysis, a strategy other than strategy 3 would be least expensive for some value of the variable within its plausible range. No variables of cost or probability were found to be sensitive within their plausible ranges for this tree, except that strategy 6 would cost less than strategy 3 if the cost of topical anesthesia was more than $0.30 less than the cost of block anesthesia.
The probabilities and preference values for baseline strategies and potential complications were inserted into the tree, and the average expected preference value of each management strategy was computed. The strategy producing the greatest average expected preference value was found to be strategy 1, block anesthesia with IV sedation administered by an anesthesiologist in the room (Decision Analysis Table 5). However, all of the strategies overlap significantly when using the entire plausible range of preference values assigned to the six baseline scenarios by the clinical experts. Therefore, the model is highly sensitive to these estimates.
Appendix R is a graph of the average expected cost versus the average expected preference value for each of the six anesthesia strategies. The graph shows that strategy 2 (oral sedation given preoperatively and block anesthesia intraoperatively, with an anesthesiologist on call for additional sedation if needed) is superior to all strategies except strategy 1 because the cost is virtually the same but the average expected preference value is higher. Strategy 1 is significantly more costly, but it has a higher average expected preference value than strategy 2. Whether the additional cost of having an anesthesiologist present to administer intravenous medications is justified depends on the value of the marginal increase in patient "utility." Further research is needed to address this issue.
Our decision analysis evaluated several different approaches to the delivery of anesthesia care during cataract surgery in an attempt to clarify the tradeoffs involved. We chose to evaluate traditional approaches to care as well as practice patterns not commonly employed in the United States but followed elsewhere at this time (i.e., anesthesiologist on call). The factors which had the greatest impact on the decision analysis were the costs of the anesthesiologist and the preference values assigned to the different clinical scenarios.
The decision analysis produced several interesting findings. First, the estimated rate of complications of anesthesia is sufficiently rare in all strategies that complications had a negligible effect on determining the optimal approach. Second, strategies employing a retrobulbar or peribulbar block were preferred over those using topical anesthesia. They consistently were preferred by the expert panel at a similar or lower cost (i.e., they were dominant). This finding was driven by the preference of the expert panel for retrobulbar or peribulbar block over topical anesthesia. The cost of retrobulbar or peribulbar block and topical anesthesia is almost identical. Finally, within the alternative strategies related to retrobulbar or peribulbar block, the availability of an anesthesiologist, either on call or present to provide intravenous sedation during a procedure, was preferred over having no anesthesiologist present. This preference incorporates the respondents' risk aversion for rare complications, which were not modeled in the current decision analysis. Importantly, it is unknown whether the presence of anesthesia caregivers decreases the incidence of rare complications. Intravenous sedation is also associated with some risk. Having an anesthesiologist (and/or nurse anesthetist) attend cataract surgeries, however, was estimated to significantly increase the cost. The cost for this scenario was $324.55, as opposed to $42.16 for the block strategy with oral sedation and the anesthesiologist on call (Appendix R). This additional cost was associated with an increase in the average expected preference value from 0.736 to 0.874. The increased preference elicited from the physician panel most likely reflects the added value the anesthesia provider confers. This value may incorporate increased cooperation by the patient as well as a potential safety margin. This decision analysis did not incorporate the risk of death separately. Spinal or brainstem anesthesia related to administration of a retrobulbar block without the presence of an anesthesia provider may confer a greater risk of major morbidity and mortality; however, it is unknown if the intravenous sedation/anesthesia strategy itself may also confer greater risk. Further research is required to determine whether the additional cost of an anesthesiologist/nurse anesthetist providing intravenous sedation/anesthesia and monitoring is within the threshold that either society or individuals find acceptable.
The Study of Medical Testing for Cataract Surgery is a large randomized trial funded by the Agency for Healthcare Research and Quality. The principal aim of this research project is to answer the question, "Does routine preoperative medical testing before cataract surgery reduce perioperative morbidity and mortality?" In addition to the collection of data on adverse medical events, data were also collected on the anesthesia management strategies employed, and patients were asked a series of questions regarding perception of pain and side effects of their anesthesia experience. A manuscript describing the findings related to patient report of pain and side effects of anesthesia has been published (Katz, Feldman, Bass et al., 2000). An abstract summarizing this work follows.
The objective of the research is to compare patient reports of intraoperative pain and postoperative side effects between those receiving injectable and those receiving topical anesthesia for cataract surgery with and without sedation.
The research is designed as a prospective cohort study.
The study covers 19,250 men and women age 50 years and older undergoing cataract surgery at nine centers in the United States and Canada between June 1995 and June of 1997.
The intervention is topical or injectable anesthesia with or without sedation.
Patient ratings of intraoperative pain, satisfaction with pain management, and early postoperative side effects (drowsiness, anxiety, and nausea) are given.
Ninety-seven percent of patients were very satisfied with their pain management, and this did not differ by anesthesia type. Nearly 10 percent (9.4 percent) of patients receiving topical anesthesia with no intravenous or oral sedation reported any pain during surgery. After adjusting for age, gender, race, American Society of Anesthesiology risk class, self-reported health status, and duration of surgery, the reporting of any pain during surgery was 66 percent lower for patients receiving injectable local anesthesia without sedation, and 54 percent lower among those receiving injectable anesthesia with sedation. Eighteen percent of sedated patients reported postoperative drowsiness, compared with 11 percent among those who were not sedated. This difference was largely due to oral rather than intravenous sedation. Anxiety was more commonly reported among those receiving injectable anesthesia without sedation than among the other groups. Nausea was more common among those receiving any form of sedation, regardless of whether they had topical or injectable anesthesia.
The percentage of patients reporting intraoperative pain and early postoperative side effects was small. Satisfaction with pain management did not vary by type of anesthesia, but topical anesthesia was associated with greater reporting of intraoperative pain, regardless of whether oral or intravenous sedation was used. Side effects such as drowsiness and nausea were more likely to be reported if sedation was used, regardless of whether local anesthesia was topical or injectable.
A question raised by the core technical consultants was whether the location of performance of cataract surgery might affect outcome. This issue was not addressed by the published literature.
As part of the supplemental analysis performed for a study funded by the Anesthesia Patient Safety Foundation, the rates of readmission and death after cataract surgery were assessed according to venue of care. A 5-percent random sample of national Medicare claims files from 1994 to 1996 was analyzed. The sample included approximately 1.2 million covered lives. The population covered by the data set is 62 percent female and 90 percent Caucasian. Excluded from the data set are retired railroad workers and health maintenance organization enrollees. Cataract was identified by the presence of Current Procedural Terminology (CPT) codes flagged in Medicare Part B claims. Surgical site was defined as either inpatient hospital, outpatient hospital, freestanding ambulatory surgical center, or office according to coding of location of care in the claims files. Admission was defined as return after discharge to an inpatient hospital.
Table 1 in Appendix S illustrates the rate of readmission within 1 to 7 days of surgery for patients who underwent their cataract surgery as an inpatient, as an outpatient at a hospital, at ambulatory surgery centers, and at office-based settings.
A logistic regression equation was developed to predict readmission within 30 days of surgery. The logistic regression adjusted for age (65-69, 70-74, 75-79, 80-84, 85-89, and 85 or more years old), previous medical admissions to an inpatient hospital during the 6 months prior to the surgery, and the Charlson index of comorbidity (Charlson, Pompei, Ales et al., 1987). Factors which significantly predicted an increased rate of readmission were determined compared to a reference standard of a 65- to 69-year-old male having the cataract extraction in an outpatient hospital setting (Table 2, Appendix S). The predictive factors were age greater than 80 years, prior hospital admission, Charlson index, and surgery performed as an inpatient or at an ambulatory surgery center.
The findings indicate that older patients with increased comorbidity have a greater risk of admission after cataract surgery. Not surprisingly, the rare patient admitted in advance of cataract surgery (often for medical management) is more likely to be readmitted. The ambulatory surgery setting is associated with a lower rate of readmission than a hospital-based setting. Office-based settings have a higher rate of readmission, but the small sample size limits the significance of the finding. Should office-based cataract surgery become more prevalent, it would be important to reevaluate this issue.
| Participants in the Peer Review Process Evidence Report on Anesthesia Management During Cataract Surgery | |
|---|---|
| Reviewer | Organization |
| Dr. James Arens | American Society of Anesthesiologists |
| Mr. Jeffery Beutler | American Association of Nurse Anesthetists |
| Dr. Gary Fanning | Society for Excellence in Eye Care Ophthalmic Anesthesia Society |
| Dr. William Golden | American College of Physicians-American Society of Internal Medicine |
| Ms. Jacqueline Harden | Technical Expert Consultant |
| Dr. Michael LeFevre | American Association of Family Physicians |
| Dr. Stephen Obstbaum | Technical Expert Consultant American Academy of Ophthalmology |
| Dr. Brent Petty | Technical Expert Consultant |
| Dr. Marymargaret Sharp-Pucci | Blue Cross/Blue Shield Association |
| Dr. Robert Stoelting | Anesthesia Patient Safety Foundation |
| Dr. John Whyte | Health Care Financing Administration |
| Dr. Henry Wong | Technical Expert Consultant |
Potential Topics for Evidence-Based Report on Anesthesia Management for Cataract Surgery Name:
The Johns Hopkins University Evidence-Based Practice Center will be developing an evidence report on management of anesthesia for cataract surgery for the Agency for Health Care Policy and Research in the U.S. Department of Health and Human Services. We are soliciting input from experts with varied perspectives on key questions regarding anesthesia during cataract surgery.
PLEASE ASSIST US IN IDENTIFYING, FROM YOUR PERSPECTIVE AS_________________, WHAT ARE THE MOST IMPORTANT QUESTIONS THAT SHOULD BE ADDRESSED.
Please return your form by December 14.
Please read the following seventeen questions regarding anesthesia management during cataract surgery that are being considered for in-depth examination in our study. Write in the space provided any other questions that you think are particularly relevant or controversial. Then, please prioritize the six questions that you deem to be the most important for us to address in the planned evidence report, and rank them in order of importance, with number 1 being the most important, (you may include in this ranking any additional questions you have written).
| Rank 1-6 1=most important | Possible Questions | Comments |
|---|---|---|
| Is there evidence supporting the use of preoperative medication and intraoperative sedation? | ||
| Is there evidence favoring specific pre-and intraoperative sedation strategies/drugs? | ||
| What are the complication rates of the medications used for pre- and intraoperative sedation? | ||
| What are the costs and benefits associated with different approaches to sedating the patient for intraocular surgery? | ||
| Which regional anesthetic agent (or combination of agents) results in the least sensation of discomfort for the patient? | ||
| Is there evidence supporting the routine use of one form of regional anesthesia over another Re: adequacy of pain control/comfort/patient satisfaction? | ||
| Is there evidence supporting the use of one form of regional anesthesia over another Re: complication rates? | ||
| Is there evidence to support the use of supplemental agents to enhance local anesthesia performance (e.g., hyaluronidase, heat and ph.. adjustment) for retro/peribulbar injections? | ||
| Is there evidence that the rate of complications associated with retro- and peribulbar injections varies with the training (experience, subspecialty, etc.) of the person administering the block? | ||
| Is there evidence supporting the safety and effectiveness of intracameral lidocaine for ocular anesthesia | ||
| What is the cost-effectiveness of different strategies for managing pain during cataract surgery? | ||
| What is the cost-effectiveness of different strategies for managing blood pressure and heart rate during cataract surgery? | ||
| What is the cost-effectiveness of different strategies for managing anxiety during cataract surgery? | ||
| Is there evidence that the level of training of the individual providing anesthesia monitoring (e.g., anesthesiologist, nurse anesthetist, nurse) is associated with varying patient outcomes? | ||
| Is there evidence for an effect of patient characteristics (e.g., medical comorbidity and current medications) on outcomes of anesthesia management for cataract surgery? | ||
| Is there evidence that the location (hospital, ASC, office) of anesthesia management for cataract surgery is related to patient outcome? | ||
| Is there evidence of the level or intensity of monitoring (e.g., PO2, blood pressure, EKG) necessary to optimize patient care? | ||
| Is there evidence that specific patient characteristics favor the use of one form of regional anesthesia (block, topical, etc.) over another? | ||
| Is there evidence that the content of a preoperative medical examination or the training (e.g., surgeon, anesthesiologist, nurse practitioner, other) of the individual performing it effects outcomes of anesthesia management for cataract surgery? | ||
| (OTHER) | ||
How might your organization use an evidence report on anesthesia management for cataract surgery? Check all that apply
Would use report to facilitate development of a new practice guideline on management of anesthesia during cataract surgery
Would use report to assess the appropriateness or our organization's existing guidelines on management of anesthesia during cataract surgery
Would use report to prepare educational materials for physicians
Would use report to prepare educational materials for patients
Other (please specify)__________________________________________________
Other (please specify)___________________________________________________
Other Comments?___________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________________
_____________________________________________________________________
******************************************************************************
| Completed by:_____________________________________________________________ | ||
| Last Name | First Name | |
| Telephone #:___(______)______________ | Fax #:___(_______)___________________ |
Thank you for your input!
Preliminary PubMed Search
(("cataract"[MeSH Terms] OR cataract*[Text Word])
AND
(((("anesthesia"[MeSH Terms] OR anesthe*[Text Word]) OR anaesthe*[Text Word]) OR
"hypnotics and sedatives"[MeSH Terms]) OR sedat*[Text Word]))
Within database of results from above search
remove:
letter [pt]
editorial [pt]
review [pt]
non-English language
animal studies
limit to specific study designs:
randomized controlled trial [pt]
clinical trial [pt] (not included in above)
follow-up studies [MeSH Terms] OR follow-up* [Text Word]
cohort studies [MeSH Terms] OR cohort [Text Word]
comparative study [MeSH Terms] OR compara* [Text Word]
experimental study [Text Word] or experiment* [Text Word]
treatment outcome [MeSH Terms]
trial* [Text Word]
random* [Text Word]
case series [Text Word]
case control [Text Word]
CENTRAL Core Search Strategy
cataract*.me
cataract*
#1 or #2
anesthesia*.me
anesthe*
anaesthe*
#4 or #5 or #6
hypnotics-and-sedatives*.me
sedat*
#8 or #9
#7 or #10
#3and #11
PubMed Core Search Strategy
Core cataract search strategy
(cataract [mh] OR cataract*[tw]) AND (anesthesia [mh] OR anesthe*[tw] OR anaesthe*[tw] OR hypnotics and sedatives [mh] OR sedat*[tw])
combined with:
Optimal search strategy for the retrieval of controlled trials using PubMed : Phases 1, 2 and 3 (Robinson, Hinegardner, and Lansung, 1998)
(randomized controlled trial [pt] OR controlled clinical trial [pt] OR randomized controlled trials [mh] OR random allocation [mh] OR double-blind method [mh] OR single-blind method [mh] OR clinical trial [pt] OR clinical trials [mh] OR (clinic* [tw] AND trial* [tw]) OR ((singl* [tw] OR doubl* [tw] OR trebl* [tw] OR tripl* [tw]) AND (mask* [tw] OR blind* [tw])) OR (latin [tw] AND square [tw]) OR placebos [mh] OR placebo* [tw] OR random* [tw] OR research design [mh:noexp] OR comparative study [mh] OR evaluation studies [mh] OR follow-up studies [mh] OR prospective studies [mh] OR cross-over studies [mh] OR control* [tw] OR prospectiv* [tw] OR volunteer* [tw] OR case report[mh] OR (case[tw] AND series[tw])) NOT (animal [mh] NOT human [mh])
NOTE: items underlined added to strategy for the cataract literature search
Modified PubMed Core Search Strategy
Modified core cataract search strategy
((("eye"{MeSH Terms] AND ("surgery"[MeSH Terms] OR surg*[tw])) AND (((anesthesia [MeSH Terms] OR anesthe*[tw] OR anaesthe*[tw]) OR hypnotics and sedatives [MeSH Terms] OR sedat*[tw])) NOT (("cataract"[MeSH Terms] OR cataract*[tw]))
combined with:
Optimal search strategy for the retrieval of controlled trials using PubMed: Phases 1, 2 and 3 (Robinson, Hinegardner, and Lansung, 1998)
(randomized controlled trial [pt] OR controlled clinical trial [pt] OR randomized controlled trials [mh] OR random allocation [mh] OR double-blind method [mh] OR single-blind method [mh] OR clinical trial [pt] OR clinical trials [mh] OR (clinic* [tw] AND trial* [tw]) OR ((singl* [tw] OR doubl* [tw] OR trebl* [tw] OR tripl* [tw]) AND (mask* [tw] OR blind* [tw])) OR (latin [tw] AND square [tw]) OR placebos [mh] OR placebo* [tw] OR random* [tw] OR research design [mh:noexp] OR comparative study [mh] OR evaluation studies [mh] OR follow-up studies [mh] OR prospective studies [mh] OR cross-over studies [mh] OR control* [tw] OR prospectiv* [tw] OR volunteer* [tw] OR case report[mh] OR (case[tw] AND series[tw])) NOT (animal [mh] NOT human [mh])
NOTE: items underlined added to strategy for the cataract literature search
Priority Journals
Coverage in Databases as of January 25, 1999
| Journal name | Cochrane hand searching (dates of registered searches) 1 | PubMed (date of most recent citation) |
|---|---|---|
| American Journal of Ophthalmology | None | Dec 1998 |
| Anesthesiology | 1980, 1986-90, 1993 | Jan 1999 |
| Anesthesia and Analgesia | 1988-present | Jan 1999 |
| Archives of Ophthalmology | 1964-93 | Dec 1998 |
| British Journal of Ophthalmology | 1948-93 | Sept 1998 |
| Canadian Journal of Anaesthesia | 1954-93 | Oct 1998 |
| Journal of Cataract Refractive Surgery | 1993-95 | Jan 1999 |
| Journal of Clinical Anesthesia | 1988-present | Dec 1998 |
| Ophthalmic Surgery | 1968-97 | July/Aug 1995 |
| Ophthalmology | 1970, 1981-93 | Dec 1998 |
In addition to hand searching, the Cochrane Collaboration also searches electronic databases, such as MEDLINE and EMBASE, for controlled trials.
| Cataract Abstract Review Form | Reviewer: _________ Data Entry: _________ |
Delete, because article(check one):
|
|
OPHTHALMIC ANESTHESIA LITERATURE REVIEW
QUALITY ASSESSMENT FORM
1. Article ID number: _______________________________________
2. First author: ____________________________________________
3a. Primary Reviewer:_______________________________________
3b. Secondary Reviewer:_____________________________________
Date of review:_____________________________
BASIC FEATURES (circle if answer is true, circle only one):
did NOT address human data
did NOT address anesthesia management for cataract surgery
did NOT report data separately for cataract surgery
ONLY addressed general anesthesia
adults are NOT part of the population
NO original data
was NOT controlled trial or case series > 100 patients
meeting abstract
data not presented in an abstractable format
Are outcomes assessed in article the clinically relevant ones.?...................................................
Yes......... No
For articles focusing on regional or topical anesthesia,
is the technique assessed in article relevant to 1999?................................................................
Yes ....... No
For articles focusing on sedation, is the technique
assessed in article relevant to 1999?.................................................................................
Yes ....... No
IF THE RESPONSE TO QUESTION 6, 7, OR 8 IS NO-STOP, REJECT ARTICLE
Type of study: CIRCLE ALL THAT APPLY
Safety of regional anesthesia
Comfort/pain control of regional anesthesia
Sedation strategies (IV/Oral)
Personnel, setting, and outcomes
Effectiveness of anesthesia
Other: _______________________
Indicate study design. (Circle the one letter listed below that describes the study design.)
Randomized trial
Non-randomized controlled trial
Cohort
Case-control
Cross-sectional
Clinical series
Other (specify type)_____________
| *11a. If cohort or case-control, what was type of control? (circle response) | ||
| a | b | c |
| Concurrent | Historical | Can't tell |
| *11b Were controls matched? (circle response) | ||
| a | b | c |
| Yes | No | Cant'tell |
| *11c Was the choice of control group reasonable? (circle response) | ||
| a | b | c |
| Yes | No | Cant'tell |
Was the setting and population from which study sample drawn described and dates of study reported?
adequate (setting AND population described AND start date and end date specified)
fair (one or more of these NOT reported OR poor descriptions)
inadequate (not specified)
not applicable
Were detailed inclusion/exclusion criteria provided, so as to allow replication?
adequate (detailed description of specific inclusion and exclusion criteria OR statement that all consecutive patients enrolled)
fair (some description but would be difficult to replicate based on information provided OR consecutive patients without describing exclusion)
inadequate (minimal description or none at all)
not applicable
Was there information on patients excluded/not participating provided?
adequate (all reasons for exclusion AND # excluded or no exclusions)
fair (only one of above criteria specified or information not quite sufficient to allow replication)
inadequate (none of above criteria specified)
not applicable
Does the study describe patients' characteristics at enrollment in 2 key areas?
demographics:
age
co-morbidities:
h/o Hypertension
h/o DM
h/o CAD
ASA risk class
Other
good (must include age and ASA or 2+ major comorbidities)
adequate (at least age and 1 comorbidity)
fair (at least age)
inadequate
not applicable
Describe exclusion criteria, if provided in report:_____________________________________________________
_______________________________________________________________________________________________________
_______________________________________________________________________________________________________
_______________________________________________________________________________________________________
Was assignment of patients to study groups randomized?
yes (investigators could not predict assignment)
partial (used DOB, date of admission, hospital #, or alternating scheme for assignment OR did not state method of randomization)
not randomized
unclear
not applicable
Was there masking of treatment supervisors, patients, and outcome assessors?
adequate (all appropriate individuals masked, including all treatment arms)
fair (only 2 of the 3 masked, or some but not all of the arms masked in all 3 ways)
poor (only 1 of the 3 masked)
none of the 3 masked or unknown
not applicable
Did the groups have any important differences on key factors at baseline?
key factors:
demographic indicators
medical comorbidity indicators
groups equivalent in both demographic characteristics AND medical comorbidity
groups have an important difference on demographic characteristics OR medical comorbidity
groups differ in both demographic characteristics AND medical comorbidity
analysis not done
not applicable or impossible to tell
Was there a complete description of the main anesthesia regimen of interest in the study?
adequate (protocol could be replicated given the completeness and detail e.g. procedures,
drugs, dose, route, duration)
fair (some detail but insufficient to ensure replication)
inadequate (very little or no detail)
not applicable
Was there a description of other ancillary medications/procedures given to each treatment group?
adequate (e.g. drug name, dose, frequency, route, duration, procedure)
fair (some description but would be difficult to replicate with information provided)
inadequate (not described or not mentioned)
not applicable
Were there any differences in ancillary medications/procedures between the treatment groups which could have affected results?
no differences (essentially the same)
minor differences (minor differences in protocols)
major differences or differences not discussed (e.g. different drugs/procedures between groups)
can't tell
not applicable
Was there an adequate report of the duration of surgery?
adequate (shows distribution)
fair (mean or median only)
inadequate
not applicable
Were there any differences in duration of surgery between the treatment groups which could have affected results?
no differences minor differences
major differences or differences not discussed
can't tell
not applicable
Which of the following outcomes were reported?
efficacy of block
complications of block
efficacy of sedation
complications of sedation
2 or more of the above
1 of the above
none of the above
Were the frequency and duration of evaluations standardized?
yes
no
can't tell
not applicable
Were the outcome assessment procedures objective?
adequate (accepted or reasonable measurement method)
fair
inadequate (inadequate or absent)
not applicable
What was the planned length of follow-up?
7+ days
1 day
discharge
duration of surgery
immediate effect of anesthesia
not stated
not applicable (e.g., study on acute conversion only)
For primary endpoints, is the magnitude of difference between groups AND an index of variability (e.g. test statistic, p value, standard error, confidence interval) stated?
adequate (both reported with index of variability using standard error or confidence intervals)
fair (both reported with index of variability using only test statistic or p value)
inadequate (one or both not reported)
not applicable
Were the appropriate analyses and statistical tests performed?
adequate (yes for all analyses)
fair (yes for only some of the analyses)
inadequate (not for any of the analyses or can't tell)
not applicable
If groups were not comparable at study onset, was there adjustment for potential confounders with multivariate or stratified analyses AND were confounders coded in a way to make such control adequate?
adequate (adjustment done AND confounders appropriately coded)
fair (adjustment done BUT confounders not coded appropriately OR coding unclear)
inadequate (adjustment not done OR comparability not previously reported)
not applicable
Were cross-overs handled appropriately in analysis?
sensitivity analysis
by intention to treat
by 'treatment received' analysis only
by none of the above
unknown
not applicable
EVIDENCE REPORT ON ANESTHESIA MANAGEMENT FOR CATARACT SURGERY
ARTICLE CONTENT ASSESSMENT
1. Article ID__________________________________________.
2. First Author Name___________________________________.
3. Name of Primary Reviewer____________________________.
4. Name of Secondary Reviewer__________________________.
4a. Date of Review___________________________________.
5. Peribulbar Block administered?.....................
Yes .....
No .....
Can't Tell → (If No, or Can't Tell Go To Question 14, page 7)
6. Details of block given?.............................
Yes .....
No .....
Can't Tell → (If No, or Can't Tell Go To Question 14, page 7)
7. Description of Peribulbar Block (indicate location and volume for all that apply):
| GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
|
|
|
|
|
|
PERIBULBAR BLOCK NEEDLE
8. Peribulbar Block, Needle Length
| GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|
|
inches
mm
Can't Tell |
inches
mm
Can't Tell |
inches
mm
Can't Tell |
inches
mm
Can't Tell |
inches
mm
Can't Tell |
inches
mm
Can't Tell |
inches
mm
Can't Tell |
9. Peribulbar Block, Needle Gauge
| GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|
|
30 (0.3mm)
27 (0.4mm)
25 (0.5mm)
Other/Specify
_____________
Can't Tell |
30 (0.3mm)
27 (0.4mm)
25 (0.5mm)
Other/Specify
_____________
Can't Tell |
30 (0.3mm)
27 (0.4mm)
25 (0.5mm)
Other/Specify
_____________
Can't Tell |
30 (0.3mm)
27 (0.4mm)
25 (0.5mm)
Other/Specify
_____________
Can't Tell |
30 (0.3mm)
27 (0.4mm)
25 (0.5mm)
Other/Specify
_____________
Can't Tell |
30 (0.3mm)
27 (0.4mm)
25 (0.5mm)
Other/Specify
_____________
Can't Tell |
30 (0.3mm)
27 (0.4mm)
25 (0.5mm)
Other/Specify
_____________
Can't Tell |
| 10. | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Peribulbar Block, Needle Tip |
Sharp
Blunt
Not Specified |
Sharp
Blunt
Not Specified |
Sharp
Blunt
Not Specified |
Sharp
Blunt
Not Specified |
Sharp
Blunt
Not Specified |
Sharp
Blunt
Not Specified |
Sharp
Blunt
Not Specified |
| 11. | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Peribulbar Block, Personnel Administering Block |
Surgeon
Anesthesiologist
CRNA
Other_______
Can't Tell |
Surgeon
Anesthesiologist
CRNA
Other_______
Can't Tell |
Surgeon
Anesthesiologist
CRNA
Other_______
Can't Tell |
Surgeon
Anesthesiologist
CRNA
Other_______
Can't Tell |
Surgeon
Anesthesiologist
CRNA
Other_______
Can't Tell |
Surgeon
Anesthesiologist
CRNA
Other_______
Can't Tell |
Surgeon
Anesthesiologist
CRNA
Other_______
Can't Tell |
12. PERIBULBAR BLOCK, ANESTHETIC AGENTS (for each agent used, indicate concentration and volume).
| 12A. Bupivacaine (Marcaine, Sensorcaine) | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Concentration | |||||||
| Volume |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
| 12B. Etidocaine (Duranest) | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Concentration | |||||||
| Volume |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
| 12C. Lidocaine (Lignocaine, Xylocaine, Ultracaine) | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Concentration | |||||||
| Volume |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
| 12D. Mepivicaine (Carbocaine, Polocaine) | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Concentration | |||||||
| Volume |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
| 12E. Prilocaine | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Concentration | |||||||
| Volume |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
| 12F. Procaine (Novocaine) | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Concentration | |||||||
| Volume |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
| 12G. Peribulbar Block Other Anesthesia Agents: (specify) | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Concentration | |||||||
| Volume |
| 12H. Peribulbar Block Other Anesthesia Agents: (specify) | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Concentration | |||||||
| Volume |
| 12I. Peribulbar Block Other Anesthesia Agents: (specify) | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Concentration | |||||||
| Volume |
13.
| Peribulbar Block, Comments: | |||||||
|---|---|---|---|---|---|---|---|
14. Retrobulbar Block administered? .....................
Yes .....
No .....
Can't Tell → (If No, or Can't Tell Go To Question 23, page 12)
15. Details of block given? .............................
Yes .....
No .....
Can't Tell → (If No, or Can't Tell Go To Question 23, page 12)
16. Description of Retrobulbar Block (indicate location and volume for all that apply):
| GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
|
|
|
|
|
|
RETROBULBAR BLOCK NEEDLE
17. Retrobulbar Block, Needle Length
| GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|
| ______
inches
mm
Can't Tell | ______
inches
mm
Can't Tell | ______
inches
mm
Can't Tell | ______
inches
mm
Can't Tell | ______
inches
mm
Can't Tell | ______
inches
mm
Can't Tell | ______
inches
mm
Can't Tell |
18. Retrobulbar Block, Needle Gauge
| GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|
|
30 (0.3mm)
27 (0.4mm)
25 (0.5mm)
Other/Specify
_____________
Can't Tell |
30 (0.3mm)
27 (0.4mm)
25 (0.5mm)
Other/Specify
_____________
Can't Tell |
30 (0.3mm)
27 (0.4mm)
25 (0.5mm)
Other/Specify
_____________
Can't Tell |
30 (0.3mm)
27 (0.4mm)
25 (0.5mm)
Other/Specify
_____________
Can't Tell |
30 (0.3mm)
27 (0.4mm)
25 (0.5mm)
Other/Specify
_____________
Can't Tell |
30 (0.3mm)
27 (0.4mm)
25 (0.5mm)
Other/Specify
_____________
Can't Tell |
30 (0.3mm)
27 (0.4mm)
25 (0.5mm)
Other/Specify
_____________
Can't Tell |
| 19. | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Retrobulbar Block, Needle Tip |
Sharp
Blunt
Not Specified |
Sharp
Blunt
Not Specified |
Sharp
Blunt
Not Specified |
Sharp
Blunt
Not Specified |
Sharp
Blunt
Not Specified |
Sharp
Blunt
Not Specified |
Sharp
Blunt
Not Specified |
| 20. | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Retrobulbar Block, Personnel Administering Block |
Surgeon
Anesthesiologist
CRNA
Other_________
Can't Tell |
Surgeon
Anesthesiologist
CRNA
Other_________
Can't Tell |
Surgeon
Anesthesiologist
CRNA
Other_________
Can't Tell |
Surgeon
Anesthesiologist
CRNA
Other_________
Can't Tell |
Surgeon
Anesthesiologist
CRNA
Other_________
Can't Tell |
Surgeon
Anesthesiologist
CRNA
Other_________
Can't Tell |
Surgeon
Anesthesiologist
CRNA
Other_________
Can't Tell |
21A. RETROBULBAR BLOCK, ANESTHETIC AGENTS (for each agent used, indicate concentration and volume).
| 21A. Bupivacaine (Marcaine, Sensorcaine) | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Concentration | |||||||
| Volume |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
| 21B. Etidocaine (Duranest) | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Concentration | |||||||
| Volume |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
| 21C. Lidocaine (Lignocaine, Xylocaine, Ultracaine) | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Concentration | |||||||
| Volume |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
| 21D. Mepivicaine (Carbocaine, Polocaine) | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Concentration | |||||||
| Volume |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
| 21E. Prilocaine | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Concentration | |||||||
| Volume |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
| 21F. Procaine (Novocaine) | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Concentration | |||||||
| Volume |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
| 21G. Other | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Concentration | |||||||
| Volume |
| 21H. Other | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Concentration | |||||||
| Volume |
| 21I. Other | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Concentration | |||||||
| Volume |
22.
| Retrobulbar Block, Comments: |
|---|
23. Subconjunctival or Sub-Tenon's local block used? .............
Yes .....
No .....
Can't Tell → (If No, or Can't Tell Go To Question 28, page 14)
24. Details of block given? ......................................
Yes .....
No .....
Can't Tell → (If No, or Can't Tell Go To Question 28, page 14)
25.
| Description of Subconjunctival or Sub-Tenon's Block | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Cannula Gauge | |||||||
| Needle Gauge |
30 (0.3mm)
27 (0.4mm)
25 (0.5mm)
Other
___________ |
30 (0.3mm)
27 (0.4mm)
25 (0.5mm)
Other
__________ |
30 (0.3mm)
27 (0.4mm)
25 (0.5mm)
Other
___________ |
30 (0.3mm)
27 (0.4mm)
25 (0.5mm)
Other
___________ |
30 (0.3mm)
27 (0.4mm)
25 (0.5mm)
Other
__________ |
30 (0.3mm)
27 (0.4mm)
25 (0.5mm)
Other
__________ |
30 (0.3mm)
27 (0.4mm)
25 (0.5mm)
Other
__________ |
| Volume |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
26. SUBCONJUNCTIVAL/SUB-TENON'S BLOCK, ANESTHETIC AGENTS (for each agent used, indicate volume).
| 26A. Bupivacaine (Marcaine, Sensorcaine) | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Volume |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
| 26B. Etidocaine (Duranest) | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Volume |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
| 26C. Lidocaine (Lignocaine, Xylocaine, Ultracaine) | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Volume |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
| 26D. Mepivicaine (Carbocaine, Polocaine) | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Volume |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
| 26E. Prilocaine | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Volume |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
| 26F. Procaine (Novocaine) | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Volume |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
| 26G. Other Anesthetic Agent (specify) | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Volume |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
| 26H. Other Anesthetic Agent (specify) | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Volume |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
| 26I. Other Anesthetic Agent (specify) | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Volume |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
27.
| Subconjunctival or Sub-Tenon's Block, Comments: |
|---|
28. Lid Block/Facial Nerve Block
| GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|
|
Yes
No
Can't Tell |
Yes
No
Can't Tell |
Yes
No
Can't Tell |
Yes
No
Can't Tell |
Yes
No
Can't Tell |
Yes
No
Can't Tell |
Yes
No
Can't Tell |
| 29. Study design included use of additional agents: | Clonidine...........................
Yes..........
No .........
Can't Tell |
| Epinephrine......................
Yes..........
No .........
Can't Tell | |
| Hyaluronidase...................
Yes..........
No .........
Can't Tell | |
| Other..................................
Yes..........
No .........
Can't Tell _______________________________ |
| 29A. Clonidine | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Concentration |
0.5%
1.0%
2.0% |
0.5%
1.0%
2.0% |
0.5%
1.0%
2.0% |
0.5%
1.0%
2.0% |
0.5%
1.0%
2.0% |
0.5%
1.0%
2.0% |
0.5%
1.0%
2.0% |
| Volume |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
| 29B. Epinephrine | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Agent Used? |
Yes
No |
Yes
No |
Yes
No |
Yes
No |
Yes
No |
Yes
No |
Yes
No |
| 29C. Hyaluronidase (Wydase) | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Agent Used? |
Yes
No |
Yes
No |
Yes
No |
Yes
No |
Yes
No |
Yes
No |
Yes
No |
| 29D. Other | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G | |
|---|---|---|---|---|---|---|---|---|
| Agent ______________________ | ||||||||
| Concentration | ||||||||
| Volume |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
| 29E. Other | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G | |
|---|---|---|---|---|---|---|---|---|
| Agent ______________________ | ||||||||
| Concentration | ||||||||
| Volume |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
| 29F. Other | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G | |
|---|---|---|---|---|---|---|---|---|
| Agent ______________________ | ||||||||
| Concentration | ||||||||
| Volume |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
<4cc's
4-6cc's
>6cc's
can't tell |
30.
| Additional Local Agents Comments: |
|---|
31. Study uses additional techniques for local block ...........
Yes .....
No .....
Can't Tell → (If No, or Can't Tell Go To Question 33, page 18)
| 31A. | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Warming of Anesthesia Agents |
|
|
|
|
|
|
|
| 31B. | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| pH Buffering |
|
|
|
|
|
|
|
| 31C. | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Injection Speed |
|
|
|
|
|
|
|
| 31D. | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Injection Pressure |
|
|
|
|
|
|
|
| 31E. | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Other(specify)_____________________ |
32.
| Comments on Additional Techniques: |
|---|
33. Study design included topical anesthesia ......................
Yes .....
No .....
Can't Tell → (If No, or Can't Tell Go To Question 38, page 20)
34. Details of topical anesthesia given........
Yes .......
No
35. Topical Anesthesia Agents:
Complete, as indicated, for all agents listed.
| GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G | |
|---|---|---|---|---|---|---|---|
| 35A. EMLA |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
| 35B. Lidocaine Gel |
1%
2%
4% |
1%
2%
4% |
1%
2%
4% |
1%
2%
4% |
1%
2%
4% |
1%
2%
4% |
1%
2%
4% |
| 35C. Proparacaine | ______% ______Total Drops | ______% ______Total Drops | ______% ______Total Drops | ______% ______Total Drops | ______% ______Total Drops | ______% ______Total Drops | ______% ______Total Drops |
| 35D. Tetracaine | ______% ______Total Drops | ______% ______Total Drops | ______% ______Total Drops | ______% ______Total Drops | ______% ______Total Drops | ______% ______Total Drops | ______% ______Total Drops |
| 35E. Other Topical Agent (specify) | ______% ______Total Drops | ______% ______Total Drops | ______% ______Total Drops | ______% ______Total Drops | ______% ______Total Drops | ______% ______Total Drops | ______% ______Total Drops |
| 35F. Other Topical Agent (specify) | ______% ______Total Drops | ______% ______Total Drops | ______% ______Total Drops | ______% ______Total Drops | ______% ______Total Drops | ______% ______Total Drops | ______% ______Total Drops |
| 35G. Other Topical Agent (specify) | ______% ______Total Drops | ______% ______Total Drops | ______% ______Total Drops | ______% ______Total Drops | ______% ______Total Drops | ______% ______Total Drops | ______% ______Total Drops |
36.
| Intracameral Lidocaine | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
|
0.5%
1.0%
2.0% |
0.5%
1.0%
2.0% |
0.5%
1.0%
2.0% |
0.5%
1.0%
2.0% |
0.5%
1.0%
2.0% |
0.5%
1.0%
2.0% |
0.5%
1.0%
2.0% |
37.
| Topical Anesthesia Comments: |
|---|
38. Study design included planned sedation .................
Yes .....
No .....
Can't Tell → (If No, or Can't Tell Go To Question 42, page 22)
| 39. Route of administration. | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
|
IV
PCA
ORAL
IM
Other, Specify
______________ |
IV
PCA
ORAL
IM
Other, Specify
______________ |
IV
PCA
ORAL
IM
Other, Specify
______________ |
IV
PCA
ORAL
IM
Other, Specify
______________ |
IV
PCA
ORAL
IM
Other, Specify
______________ |
IV
PCA
ORAL
IM
Other,Specify
______________ |
IV
PCA
ORAL
IM
Other, Specify
______________ |
40. Agent and Dose (for each agent, indicate mean total dose).
| GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G | |
|---|---|---|---|---|---|---|---|
| 40A. Oral Diazepam (Valium) Mean Total Dose |
<5.0mg
6-10 mg
>10mg
can't tell |
<5.0mg
6-10 mg
>10mg
can't tell |
<5.0mg
6-10 mg
>10mg
can't tell |
<5.0mg
6-10 mg
>10mg
can't tell |
<5.0mg
6-10 mg
>10mg
can't tell |
<5.0mg
6-10 mg
>10mg
can't tell |
<5.0mg
6-10 mg
>10mg
can't tell |
| 40B. Benadryl Mean Total Dose |
<25mg
26-50mg
>50mg
can't tell |
<25mg
26-50mg
>50mg
can't tell |
<25mg
26-50mg
>50mg
can't tell |
<25mg
26-50mg
>50mg
can't tell |
<25mg
26-50mg
>50mg
can't tell |
<25mg
26-50mg
>50mg
can't tell |
<25mg
26-50mg
>50mg
can't tell |
| 40C. Clonidine Mean Total Dose |
0.1mg
0.2mg
0.3mg
can't tell |
0.1mg
0.2mg
0.3mg
can't tell |
0.1mg
0.2mg
0.3mg
can't tell |
0.1mg
0.2mg
0.3mg
can't tell |
0.1mg
0.2mg
0.3mg
can't tell |
0.1mg
0.2mg
0.3mg
can't tell |
0.1mg
0.2mg
0.3mg
can't tell |
| 40D. Lorazepam Mean Total Dose |
<1mg
1.1-2mg
>2mg
can't tell |
<1mg
1.1-2mg
>2mg
can't tell |
<1mg
1.1-2mg
>2mg
can't tell |
<1mg
1.1-2mg
>2mg
can't tell |
<1mg
1.1-2mg
>2mg
can't tell |
<1mg
1.1-2mg
>2mg
can't tell |
<1mg
1.1-2mg
>2mg
can't tell |
| 40E. Other Oral Preoperative Medication(Specify):_______________________ Mean Total Dose | |||||||
| 40F. Other Oral Preoperative Medication (specify):_______________________ Mean Total Dose | |||||||
| 40G. Other Oral Preoperative Medication (specify):_______________________ Mean Total Dose |
41.
| Preoperative Oral Medication Comments: |
|---|
42.
Study design included use of planned intravenous or intramuscular sedation..........................
Yes .....
No .....
Can't Tell → (If No, or Can't Tell Go To Question 48, page 26)
Intravenous or Intramuscular Medications Used, for each agent used, indicate total dose.
43.
BENZODIAZEPINES
| GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G | |
|---|---|---|---|---|---|---|---|
| 43B. Diazepam (Valium) Mean Total Dose |
< 5mg
5-9.9mg
> 10mg
can't tell |
< 5mg
5-9.9mg
> 10mg
can't tell |
< 5mg
5-9.9mg
> 10mg
can't tell |
< 5mg
5-9.9mg
> 10mg
can't tell |
< 5mg
5-9.9mg
> 10mg
can't tell |
< 5mg
5-9.9mg
> 10mg
can't tell |
< 5mg
5-9.9mg
> 10mg
can't tell |
| 43C. Lorazepam (Ativan) Mean Total Dose |
< 1mg
1.1-2mg
>2mg
can't tell |
< 1mg
1.1-2mg
>2mg
can't tell |
< 1mg
1.1-2mg
>2mg
can't tell |
< 1mg
1.1-2mg
>2mg
can't tell |
< 1mg
1.1-2mg
>2mg
can't tell |
< 1mg
1.1-2mg
>2mg
can't tell |
< 1mg
1.1-2mg
>2mg
can't tell |
| 43D. Midazolam (Versed) Mean Total Dose |
< 2mg
2.1-5mg
>5mg
can't tell |
< 2mg
2.1-5mg
>5mg
can't tell |
< 2mg
2.1-5mg
>5mg
can't tell |
< 2mg
2.1-5mg
>5mg
can't tell |
< 2mg
2.1-5mg
>5mg
can't tell |
< 2mg
2.1-5mg
>5mg
can't tell |
<2mg
2.1-5mg
>5mg
can't tell |
| 43E. Other Benzodiazepines: (specify) | ________ mg | ________ mg | ________ mg | ________ mg | ________ mg | ________ mg | ________ mg |
| 43F. Other Benzodiazepines: (specify) | ________ mg | ________ mg | ________ mg | ________ mg | ________ mg | ________ mg | ________ mg |
44.
BARBITURATES
| GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G | |
|---|---|---|---|---|---|---|---|
| 44A. Methohexital (Brevital) Mean Total Dose |
< 50mg
>50mg
can't tell |
< 50mg
>50mg
can't tell |
< 50mg
>50mg
can't tell |
< 50mg
>50mg
can't tell |
< 50mg
>50mg
can't tell |
< 50mg
>50mg
can't tell |
< 50mg
>50mg
can't tell |
| 44B. Thiopentothal (Pentothal) Mean Total Dose | __________mg | __________mg | __________mg | __________mg | __________mg | __________mg | __________mg |
| 44C. Other Barbiturates: (specify) Mean Total Dose | __________mg | __________mg | __________mg | __________mg | __________mg | __________mg | __________mg |
| 44D. Other Barbiturates: (specify) Mean Total Dose | __________mg | __________mg | __________mg | __________mg | __________mg | __________mg | __________mg |
45.
ANALGESICS
| GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G | |
|---|---|---|---|---|---|---|---|
| 45A. Alfentanyl (Alfenta) Mean Total Dose |
< 500 mcg
> 500 mcg |
< 500 mcg
> 500 mcg |
< 500 mcg
> 500 mcg |
< 500 mcg
> 500 mcg |
< 500 mcg
> 500 mcg |
< 500 mcg
> 500 mcg |
< 500 mcg
> 500 mcg |
| 45B. Fentanyl (Sublimaze) Mean Total Dose |
< 100 mcg
101-250 mcg
> 250 mcg |
< 100 mcg
101-250 mcg
> 250 mcg |
< 100 mcg
101-250 mcg
> 250 mcg |
< 100 mcg
101-250 mcg
> 250 mcg |
< 100 mcg
101-250 mcg
> 250 mcg |
< 100 mcg
101-250 mcg
> 250 mcg |
< 100 mcg
101-250 mcg
> 250 mcg |
| 45C. Ketorolac (Toradol) Mean Total Dose |
30mg_______
60mg_______ |
30mg_______
60mg_______ |
30mg_______
60mg_______ |
30mg_______
60mg_______ |
30mg_______
60mg_______ |
30mg_______
60mg_______ |
30mg_______
60mg_______ |
| 45D. Morphine (Roxanol) Mean Total Dose |
< 5mg
5-10mg |
< 5mg
5-10mg |
< 5mg
5-10mg |
< 5mg
5-10mg |
< 5mg
5-10mg |
< 5mg
5-10mg |
< 5mg
5-10mg |
| 45E. Propofol (Diprivan) Mean Total Dose |
< 100mg
101-200mg
200mg |
< 100mg
101-200mg
200mg |
< 100mg
101-200mg
200mg |
< 100mg
101-200mg
200mg |
< 100mg
101-200mg
200mg |
< 100mg
101-200mg
200mg |
< 100mg
101-200mg
200mg |
| 45F. Other Analgesics: (specify) Mean Total Dose | |||||||
| 45G. Other Analgesics: (specify) Mean Total Dose |
46.
Other Intravenous Medications
| GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G | |
|---|---|---|---|---|---|---|---|
| 46A. Clonidine (Catapres, Combipress, Duralion) Mean Total Dose |
0.1mg
0.2mg
0.3mg |
0.1mg
0.2mg
0.3mg |
0.1mg
0.2mg
0.3mg |
0.1mg
0.2mg
0.3mg |
0.1mg
0.2mg
0.3mg |
0.1mg
0.2mg
0.3mg |
0.1mg
0.2mg
0.3mg |
| 46B. Diphenhydramine (Benadryl) Mean Total Dose |
< 25mg
25-50mg
> 50mg |
< 25mg
25-50mg
> 50mg |
< 25mg
25-50mg
> 50mg |
< 25mg
25-50mg
> 50mg |
< 25mg
25-50mg
> 50mg |
< 25mg
25-50mg
> 50mg |
< 25mg
25-50mg
> 50mg |
| 46C. Clorazepate -Dipotassium (Tranxene,Gen-xene) Mean Total Dose |
3.75mg
7.5mg |
3.75mg
7.5mg |
3.75mg
7.5mg |
3.75mg
7.5mg |
3.75mg
7.5mg |
3.75mg
7.5mg |
3.75mg
7.5mg |
| 46D. Droperidol Mean Total Dose |
0.625 mg
1.75 mg
> 2.5 mg |
0.625 mg
1.75 mg
> 2.5 mg |
0.625 mg
1.75 mg
> 2.5 mg |
0.625 mg
1.75 mg
> 2.5 mg |
0.625 mg
1.75 mg
> 2.5 mg |
0.625 mg
1.75 mg
> 2.5 mg |
0.625 mg
1.75 mg
> 2.5 mg |
| 46E. Ondansetron (Zofran) Mean Total Dose |
Yes
No |
Yes
No |
Yes
No |
Yes
No |
Yes
No |
Yes
No |
Yes
No |
| 46F. Promazine Mean Total Dose | |||||||
| 46G. Saline Placebo |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
Yes |
| 46H. Other Mean Total Dose | |||||||
| 46I. Other Mean Total Dose | |||||||
| 46J. Other Mean Total Dose |
47.
| Intravenous Medication Comments: |
|---|
48. Was unplanned sedation used?.................
Yes
No
Can't Tell (If No or Can't Tell go to Question 50, page 27)
48a. For each agent used, indicate number of patients receiving agent in each group.
| GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G | |
|---|---|---|---|---|---|---|---|
| 49A. Unplanned, Supplemental Benzodiazepines | |||||||
| 49B. Unplanned, Supplemental Barbiturates | |||||||
| 49C. Unplanned, Supplemental Propofol | |||||||
| 49D. Unplanned, Supplemental Benadryl | |||||||
| 49E. Other ________________ | |||||||
| 49F. Unplanned, Supplemental Analgesics (specify) | |||||||
| 49G. Unplanned, Supplemental Anti-emetics (specify) |
49H.
| Unplanned Sedation Comments: |
|---|
50. Did study design include any supplemental interventions? .........
Yes........
No......
Can't Tell (If No or Can't Tell go to Question 52, page 28) If yes, specify intervention received by group.
| GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|
51.
| Supplemental Interventions Comments: | ||||||
|---|---|---|---|---|---|---|
| 52. | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| 52A. Number of subjects | |||||||
| 52B. Age (mean) | |||||||
| 52C. Number of eyes | |||||||
| 52D. Number of male subjects | |||||||
| 52E. Number of white subjects | |||||||
| 52F. Number of subjects with diabetes | |||||||
| 52G. Number of smokers | |||||||
| 52H. Number of subjects with hypertension | |||||||
| 52I. Number of subjects with CAD | |||||||
| 52J. Number of subjects with CHF | |||||||
| 52K. Number of subjects with COPD | |||||||
| 52L. Mean ASA score | |||||||
| 52M. Median ASA score | |||||||
| 52N. Number of subjects with ASA score > 3 | |||||||
| 52O. Other comorbidity index |
52P.
| Baseline Patient Demographics Comments: | |||||||
|---|---|---|---|---|---|---|---|
53. Monitoring Used
53A. Electrocardiogram .............................
Yes.....
No......
Can't Tell
53B. ST Segment Monitoring .....................
Yes.....
No......
Can't Tell
53C. Blood Pressure ......................................
Yes......
No.......
Can't Tell
53D. Oxygen Saturation ..............................
Yes.....
No......
Can't Tell
53E. End-tidal Carbon Dioxide ..................
Yes.....
No......
Can't Tell
53F. Respiratory Rate .................................
Yes.....
No......
Can't Tell
54. Primary Monitoring Individual (check one)
Anesthesiologist...................
CRNA ..................................
RN .......................................
PA .........................................
Ophthalmologist ..............
No One ................................
Can't Tell ............................
55. Country in which study performed (specify):_____________________________________________________________
56. Specify location of surgery:
Free Standing ASC
Hospital
Office
Can't Tell
| 57. | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Routine Supplemental Oxygen |
Yes
No
Can't Tell |
Yes
No
Can't Tell |
Yes
No
Can't Tell |
Yes
No
Can't Tell |
Yes
No
Can't Tell |
Yes
No
Can't Tell |
Yes
No
Can't Tell |
| 58. | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| OR Time in minutes (also includes total operative time) | Mean__________ Median_________ | Mean__________ Median_________ | Mean__________ Median_________ | Mean__________ Median_________ | Mean__________ Median_________ | Mean__________ Median_________ | Mean__________ Median_________ |
| 59. | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Surgical Time in minutes | Mean___________ Median___________ | Mean___________ Median___________ | Mean___________ Median___________ | Mean___________ Median___________ | Mean___________ Median___________ | Mean___________ Median___________ | Mean___________ Median___________ |
| 60. | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Predominant Surgical Technique (check one only) |
PE
PE Clear Cornea
ECCE
ICCE
Can't Tell |
PE
PE Clear Cornea
ECCE
ICCE
Can't Tell |
PE
PE Clear Cornea
ECCE
ICCE
Can't Tell |
PE
PE Clear Cornea
ECCE
ICCE
Can't Tell |
PE
PE Clear Cornea
ECCE
ICCE
Can't Tell |
PE
PE Clear Cornea
ECCE
ICCE
Can't Tell |
PE
PE Clear Cornea
ECCE
ICCE
Can't Tell
|
| 61. | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Axial Length | Number >25mm__________ | Number >25mm__________ | Number >25mm__________ | Number >25mm__________ | Number >25mm__________ | Number >25mm__________ | Number >25mm__________ |
| 62. | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Assessment of Akinesia During Surgery (number of patients) | Complete________
Moderate________
Poor__________
Can't Tell
| Complete________
Moderate________
Poor__________
Can't Tell
| Complete________
Moderate________
Poor__________
Can't Tell
| Complete________
Moderate________
Poor__________
Can't Tell
| Complete________
Moderate________
Poor__________
Can't Tell
| Complete________
Moderate________
Poor__________
Can't Tell
| Complete________
Moderate________
Poor__________
Can't Tell
|
63.
| Comments on Akinesia During Surgery: | |||||||
|---|---|---|---|---|---|---|---|
64. Were complications of regional anesthesia reported? .....................
Yes .....
No → (If No, Go To Question 76, page 33)
| 65. | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Supplemental Regional Anesthesia Given (number of patients receiving) |
Drops_____
Sub-conjunctival_____
Sub-Tenon's_____
Peribulbar_____
Retrobulbar_____
Can't Tell_____ |
Drops_____
Sub-conjunctival_____
Sub-Tenon's_____
Peribulbar_____
Retrobulbar_____
Can't Tell_____ |
Drops_____
Sub-conjunctival_____
Sub-Tenon's_____
Peribulbar_____
Retrobulbar_____
Can't Tell_____ |
Drops_____
Sub-conjunctival_____
Sub-Tenon's_____
Peribulbar_____
Retrobulbar_____
Can't Tell_____ |
Drops_____
Sub-conjunctival_____
Sub-Tenon's_____
Peribulbar_____
Retrobulbar_____
Can't Tell_____ |
Drops_____
Sub-conjunctival_____
Sub-Tenon's_____
Peribulbar_____
Retrobulbar_____
Can't Tell_____ |
Drops_____
Sub-conjunctival_____
Sub-Tenon's_____
Peribulbar_____
Retrobulbar_____
Can't Tell_____
|
| GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G | |||
|---|---|---|---|---|---|---|---|---|---|
| |||||||||
| |||||||||
|
| GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G | |||
|---|---|---|---|---|---|---|---|---|---|
| |||||||||
| |||||||||
| |||||||||
| |||||||||
| |||||||||
|
75.
| Comments on Supplemental Regional Anesthesia: | |||||||
|---|---|---|---|---|---|---|---|
| 76. | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Surgeon Assessment of adequate cooperation (number of patients) |
| 77. | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Anesthesiologist/Observer assessment of adequate cooperation (number of patients) |
| 78. | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Assessment of Physician Satisfaction with the pain management technique (number of patients) | Excellent __________ Very Good _________ Good___________ Fair _______________ Poor ______________ | Excellent __________ Very Good _________ Good___________ Fair _______________ Poor ______________ | Excellent __________ Very Good _________ Good___________ Fair _______________ Poor ______________ | Excellent __________ Very Good _________ Good___________ Fair _______________ Poor ______________ | Excellent __________ Very Good _________ Good__________ Fair ________________ Poor ______________ | Excellent __________ Very Good _________ Good__________ Fair ________________ Poor ______________ | Excellent __________ Very Good _________ Good___________ Fair _______________ Poor ______________ |
79.
| Comments on Assessment of Physician Satisfaction: | |||||||
|---|---|---|---|---|---|---|---|
80. The Block
| GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G | |
|---|---|---|---|---|---|---|---|
| Recall of Block (at time of first measurement) (number of patients) | |||||||
| Pain During Block (10 point scale) | None 0 _________ Mild 1-2 ________ Moderate 3-5 ____ Severe >5 _______ | None 0 _________ Mild 1-2 ________ Moderate 3-5 ____ Severe >5 _______ | None 0 _________ Mild 1-2 ________ Moderate 3-5 ____ Severe >5 _______ | None 0 _________ Mild 1-2 ________ Moderate 3-5 ____ Severe >5 _______ | None 0 _________ Mild 1-2 ________ Moderate 3-5 ____ Severe >5 _______ | None 0 _________ Mild 1-2 ________ Moderate 3-5 ____ Severe >5 _______ | None 0 _________ Mild 1-2 ________ Moderate 3-5 ____ Severe >5 _______ |
| Pain During Block (mean) | |||||||
| Pain During Block (median) |
81. Surgical Pain
| GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G | |
|---|---|---|---|---|---|---|---|
| Recall of Surgery (at time of first measurement) (number of patients) | |||||||
| Pain During Surgery (10 point scale) | None 0 _______ Mild 1-2 ______ Moderate 3-5__ Severe >5_____ Mean ________ Median _______ | None 0 _______ Mild 1-2 ______ Moderate 3-5__ Severe >5 _____ Mean ________ Median _______ | None 0 _______ Mild 1-2 ______ Moderate 3-5__ Severe >5 _____ Mean ________ Median _______ | None 0 _______ Mild 1-2 ______ Moderate 3-5__ Severe >5 _____ Mean ________ Median _______ | None 0 _______ Mild 1-2 ______ Moderate 3-5__ Severe >5 _____ Mean ________ Median _______ | None 0 _______ Mild 1-2 ______ Moderate 3-5__ Severe >5 _____ Mean ________ Median _______ | None 0 _______ Mild 1-2 ______ Moderate 3-5__ Severe >5 _____ Mean ________ Median _______ |
| Surgical Pain: Post-op day of surgery (10 point scale), (first measurement) | None 0 _______ Mild 1-2 ______ Moderate 3-5__ Severe >5 _____ Mean ________ Median _______ | None 0 _______ Mild 1-2 ______ Moderate 3-5__ Severe >5 _____ Mean ________ Median _______ | None 0 _______ Mild 1-2 ______ Moderate 3-5__ Severe >5 _____ Mean ________ Median _______ | None 0 _______ Mild 1-2 ______ Moderate 3-5__ Severe >5 _____ Mean ________ Median _______ | None 0 _______ Mild 1-2 ______ Moderate 3-5__ Severe >5 _____ Mean ________ Median _______ | None 0 _______ Mild 1-2 ______ Moderate 3-5__ Severe >5 _____ Mean ________ Median _______ | None 0 _______ Mild 1-2 ______ Moderate 3-5__ Severe >5 _____ Mean ________ Median _______ |
| Surgical Pain: measured post-op 1 day post surgery (10 point scale) | None 0 _______ Mild 1-2 ______ Moderate 3-5__ Severe >5 _____ Mean ________ Median _______ | None 0 _______ Mild 1-2 ______ Moderate 3-5__ Severe >5 _____ Mean ________ Median _______ | None 0 _______ Mild 1-2 ______ Moderate 3-5__ Severe >5 _____ Mean ________ Median _______ | None 0 _______ Mild 1-2 ______ Moderate 3-5__ Severe >5 _____ Mean ________ Median _______ | None 0 _______ Mild 1-2 ______ Moderate 3-5__ Severe >5 _____ Mean ________ Median _______ | None 0 _______ Mild 1-2 ______ Moderate 3-5__ Severe >5 _____ Mean ________ Median _______ | None 0 _______ Mild 1-2 ______ Moderate 3-5__ Severe >5 _____ Mean ________ Median _______ |
82. Postoperative Pain
| GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G | |
|---|---|---|---|---|---|---|---|
| Postoperative Pain (number of patients) | |||||||
| Post-op Pain on day of surgery (10 point scale) (first measurement) | None 0 _______ Mild 1-2 ______ Moderate 3-5 __ Severe >5 _____ Mean ________ Median _______ | None 0 _______ Mild 1-2 ______ Moderate 3-5 __ Severe >5 _____ Mean ________ Median _______ | None 0 _______ Mild 1-2 ______ Moderate 3-5 __ Severe >5 _____ Mean ________ Median _______ | None 0 _______ Mild 1-2 ______ Moderate 3-5 __ Severe >5 _____ Mean ________ Median _______ | None 0 _______ Mild 1-2 ______ Moderate 3-5 __ Severe >5 _____ Mean ________ Median _______ | None 0 _______ Mild 1-2 ______ Moderate 3-5 __ Severe >5 _____ Mean ________ Median _______ | None 0 _______ Mild 1-2 ______ Moderate 3-5 __ Severe >5 _____ Mean ________ Median _______ |
| Post-op Pain measured > 1 day post surgery (10 point scale) | None 0 _______ Mild 1-2 ______ Moderate 3-5 __ Severe >5 _____ Mean ________ Median _______ | None 0 _______ Mild 1-2 ______ Moderate 3-5 __ Severe >5 _____ Mean ________ Median _______ | None 0 _______ Mild 1-2 ______ Moderate 3-5 __ Severe >5 _____ Mean ________ Median _______ | None 0 _______ Mild 1-2 ______ Moderate 3-5 __ Severe >5 _____ Mean ________ Median _______ | None 0 _______ Mild 1-2 ______ Moderate 3-5 __ Severe >5 _____ Mean ________ Median _______ | None 0 _______ Mild 1-2 ______ Moderate 3-5 __ Severe >5 _____ Mean ________ Median _______ | None 0 _______ Mild 1-2 ______ Moderate 3-5 __ Severe >5 _____ Mean ________ Median _______ |
| 83. Pain Assessment Technique ........... |
VAS _________________Low Anchor, _____________High Anchor |
|
Ordinal _________________Low Anchor, __________High Anchor | |
|
Other (specify)__________________________________________ |
84.
| Comments on Pain Assessment: | |||||||
|---|---|---|---|---|---|---|---|
| 85. | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Anxiety Assessment (number of patients) | None 0______ Mild 1-2______ Moderate 3-5______ Severe >5______ Mean______ Median______ | None 0______ Mild 1-2______ Moderate 3-5______ Severe >5______ Mean______ Median______ | None 0______ Mild 1-2______ Moderate 3-5______ Severe >5______ Mean______ Median______ | None 0______ Mild 1-2______ Moderate 3-5______ Severe >5______ Mean______ Median______ | None 0______ Mild 1-2______ Moderate 3-5______ Severe >5______ Mean______ Median______ | None 0______ Mild 1-2______ Moderate 3-5______ Severe >5______ Mean______ Median______ | None 0______ Mild 1-2______ Moderate 3-5______ Severe >5______ Mean______ Median______ |
| 86. Anxiety Assessment Technique ........ |
VAS _______________Low Anchor,_______________High Anchor |
|
Ordinal_____________Low Anchor,_______________High Anchor | |
|
Other (specify)_________________________________________ |
87.
| Comments on Anxiety Assessment Technique: | |||||||
|---|---|---|---|---|---|---|---|
| 88. | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Patient satisfaction with anesthesia management assessed immediate post-op (number of patients) | Excellent_______ Very Good_______ Good_______ Fair_______ Poor_______ | Excellent _______ Very Good _______ Good_______ Fair _______ Poor_______ | Excellent _______ Very Good _______ Good_______ Fair _______ Poor_______ | Excellent _______ Very Good _______ Good_______ Fair _______ Poor_______ | Excellent _______ Very Good _______ Good_______ Fair _______ Poor_______ | Excellent _______ Very Good _______ Good_______ Fair _______ Poor_______ | Excellent _______ Very Good _______ Good_______ Fair _______ Poor_______ |
89.
| Comments on Patient Satisfaction Assessment (immediate): | |||||||
|---|---|---|---|---|---|---|---|
| 90. | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Patient satisfaction with anesthesia management assessed one or more days post-op (number of patients) | Excellent _______ Very Good _______ Good_______ Fair _______ Poor_______ | Excellent _______ Very Good _______ Good_______ Fair _______ Poor_______ | Excellent _______ Very Good _______ Good_______ Fair _______ Poor_______ | Excellent _______ Very Good _______ Good_______ Fair _______ Poor_______ | Excellent _______ Very Good _______ Good_______ Fair _______ Poor_______ | Excellent _______ Very Good _______ Good_______ Fair _______ Poor_______ | Excellent _______ Very Good _______ Good_______ Fair _______ Poor_______ |
91.
| Comments on Patient Satisfaction Assessment (1+ days postop): | |||||||
|---|---|---|---|---|---|---|---|
| 92. | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Patient desires management strategy again (number of patients) |
93.
| Comments on Patient Pain and Satisfaction Assessment: | |||||||
|---|---|---|---|---|---|---|---|
94. Medical Outcomes Reported?.......................................
Yes .....
No → (If No, Go To Question 96, page 40) For each, record number of patients in each group.
| GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G | |||
|---|---|---|---|---|---|---|---|---|---|
| 94A. Myocardial Infarction | |||||||||
| 94B. New or Worsened CHF | |||||||||
| |||||||||
| |||||||||
| 94E. Stroke | |||||||||
| 94F. TIA | |||||||||
| 94G. Respiratory Failure | |||||||||
|
95.
| Adverse Medical Outcomes Comments: | |||||||
|---|---|---|---|---|---|---|---|
Complications of sedation reported? ................................
Yes .....
No → (If No, Go To Question 98, page 41) For each, record number of patients.
| GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G | |||
|---|---|---|---|---|---|---|---|---|---|
| |||||||||
| |||||||||
| |||||||||
| |||||||||
| |||||||||
| |||||||||
| 96G. Cardioversion | |||||||||
| 96H. CPR | |||||||||
| 96I. Seizure |
97.
| Complications of Sedation Comments: | |||||||
|---|---|---|---|---|---|---|---|
| 98. | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Psychomotor Scores (number of patients) | Immediate < 60 minutes________ Delayed > 60 minutes________ | Immediate < 60 minutes________ Delayed > 60 minutes________ | Immediate < 60 minutes________ Delayed > 60 minutes________ | Immediate < 60 minutes________ Delayed > 60 minutes________ | Immediate < 60 minutes________ Delayed > 60 minutes________ | Immediate < 60 minutes________ Delayed > 60 minutes________ | Immediate < 60 minutes________ Delayed > 60 minutes________ |
| 99. | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Patient Readiness for Discharge | Immediate < 60 minutes________ Delayed > 60 minutes________ | Immediate < 60 minutes________ Delayed > 60 minutes________ | Immediate < 60 minutes________ Delayed > 60 minutes________ | Immediate < 60 minutes________ Delayed > 60 minutes________ | Immediate < 60 minutes________ Delayed > 60 minutes________ | Immediate < 60 minutes________ Delayed > 60 minutes________ | Immediate < 60 minutes________ Delayed > 60 minutes________ |
| 100. | GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G |
|---|---|---|---|---|---|---|---|
| Nausea/Vomiting (number of patients) |
101.
| Recovery Characteristics Comments: | |||||||
|---|---|---|---|---|---|---|---|
102. Hemodynamics Reported?..........
Yes..........
No
| GROUP A | GROUP B | GROUP C | GROUP D | GROUP E | GROUP F | GROUP G | |||
|---|---|---|---|---|---|---|---|---|---|
| |||||||||
| |||||||||
| |||||||||
| |||||||||
|
103.
| Comments on Hemodynamics: | |||||||
|---|---|---|---|---|---|---|---|
104.
| Bottom Line Based on Article Assessment: | |||||||
|---|---|---|---|---|---|---|---|
105. Local and IV analgesia is superior, to a clinically significant degree, to local alone? .....
Supports ...
Refutes ....
No Data/Doesn't Address
106. Use of IV sedation is superior, to a clinically significant degree, to not using IV sedation for:
Patient pain anxiety and satisfaction.....................
Supports ...
Refutes ...
No Data/Doesn't Address
Effect on patient physiology (metabolic or hemodynamics)......................
Supports ...
Refutes ...
No Data/Doesn't Address
Effect on patient outcomes..............................
Supports ...
Refutes ...
No Data/Doesn't Address
Is there a difference between peribulbar and retrobulbar anesthetic block in achieving akinesia?
Is there a difference between retrobulbar and subconjunctival/sub-Tenon's anesthetic blocks in achieving akinesia?
Is there a difference between peribulbar and subconjunctival/sub-Tenon's anesthetic block in achieving akinesia?
Summary of the evidence regarding peribulbar injection and akinesia.
Summary of the evidence regarding retrobulbar anesthesia and akinesia.
Is there evidence of the effectiveness of a subconjunctival/sub-Tenon's block in producing akinesia?
Is there evidence that adding hyaluronidase to local blocks produces better akinesia than not adding hyaluronidase?
Is there evidence that certain anesthetic agents used in local blocks produce better akinesia?
Is there evidence that the volume of anesthetic used and speed of injection affect akinesia or pain during the block or surgery?
Is there evidence that the retrobulbar block technique is more or less painful than peribulbar block during administration of the block?
Is there evidence that retrobulbar block techniques are more painful for the patient while being administered than subconjunctival/sub-Tenon's block techniques?
Is there evidence that peribulbar techniques are more painful for the patient while being administered than subconjunctival/sub-Tenon's block techniques?
Summary of evidence on pain during administration of peribulbar block.
Summary of evidence regarding pain during administration of retrobulbar block.
Summary of evidence regarding pain during administration of subconjunctival/sub-Tenon's block.
Is there evidence that retrobulbar block is more or less painful for the patient during administration than topical block?
Is there evidence that peribulbar block is more or less painful for the patient during administration than topical block?
Is there evidence that subconjunctival/sub-Tenon's block is more or less painful for the patient during administration than topical block?
Is there evidence that retrobulbar block results in more or less pain than peribulbar block during cataract surgery?
Is there evidence that retrobulbar block results in more or less pain than subconjunctival/sub-Tenon's block during cataract surgery?
Is there evidence that peribulbar block results in more or less pain than subconjunctival/sub-Tenon's block during cataract surgery?
Summary of the evidence regarding pain during cataract surgery after peribulbar block.
Summary of the evidence regarding pain control during cataract surgery after retrobulbar block.
Summary of the evidence regarding pain during cataract surgery after subconjunctival/sub-Tenon's injection.
Is there evidence that retrobulbar block results in more or less pain during cataract surgery than topical block?
Is there evidence that peribulbar block results in more or less pain than topical block during cataract surgery?
Is there evidence that subconjunctival/sub-Tenon's block results in more or less pain during cataract surgery than topical anesthesia?
Summary of the evidence regarding pain during surgery after topical anesthesia.
Is there evidence that hyaluronidase added to the block decreases the pain experienced during the block?
Is there evidence that certain anesthetic agents used in local blocks produce better control of pain during cataract surgery?
Is there evidence that warming the anesthetic results in better akinesia, less pain during the block, or less pain during the operation than not warming the agents?
Is there evidence that raising the pH of the local anesthetic yields more effective or more comfortable local blocks?
Summary of the data on ocular and systemic complications reported with retrobulbar, peribulbar, subconjunctival/sub-Tenon's, and topical anesthesia.
Is intravenous or intramuscular sedation superior to local anesthesia alone for pain control, patient cooperation, anxiety control, and patient satisfaction?
Summary of evidence on the effectiveness and safety of oral and intramuscular sedation.
Summary of the evidence on the effectiveness of intravenous sedation regarding patient cooperation, pain, anxiety, satisfaction, and medical and hemodynamic complications.
Is one class of sedative associated with improved outcome compared to another class?
Is patient-controlled analgesia safe and effective?
Are the inclusion/exclusion criteria for both the search strategy and the literature abstraction clinically reasonable and clearly stated?
Yes
No, if no, please comment.
Are the questions addressed by the review clearly articulated?
Yes
No, if no, please comment.
Is it clear what patient populations are being discussed?
Yes
No, if no, please comment.
Is it clear what interventions are being discussed?
Yes
No, if no, please comment.
Is it clear what outcomes are being discussed?
Yes
No, if no, please comment.
Have we captured the important aspect of quality of studies in our assessment?
Yes
No, if no, please comment.
Were important areas overlooked?
Yes
No, if yes, please comment.
Given the ways the data were presented in the articles, was the evidence synthesized in a reasonably understandable way?
Yes
No, if no, please comment.
Was the literature content clearly summarized?
Yes
No, if no, please comment.
Is the report clear enough about the strength of the evidence available for clinical decisionmaking on the most common strategies used for anesthesia management during cataract surgery?
Yes
No, if no, please comment.
Do the conclusions flow from the evidence (strength or weakness) that is reviewed?
Yes
No, if no, please comment.
Are there any assumptions or gaps that need to be more clearly described?
Yes
No, if yes, please comment.
Are the results of this report presented in a manner that will be useful for organizations making guidelines or policy?
Yes
No, if no, please comment.
Can you think of additional research implications beyond those raised?
Yes
No, if yes, please comment.
Signature:_________________________________________ Date:_______________________
| Source | Search strategy | Date | Number of citations | ||
|---|---|---|---|---|---|
| Retrieved | Unique (included in abstract review process) | Included in article review process | |||
| PubMed | Preliminary | Dec 23, 1998 | 283 | 283 | 163 |
| CENTRAL Issue 1 1999 | CENTRAL core | Feb 1, 1999 | 192 | 16 | 4 |
| PubMed | PubMed core | Feb 9, 1999 | 529 | 182 | 9 |
| PubMed | PubMed core | Apr 5, 1999 | 537 | 14 | 1 |
| Hand search | Table of contents of priority journals and reference lists of key reviews | Apr 8, 1999 | 22 | 13 | 3 |
| PubMed | Expanded | May 3, 1999 | 294 | 231 | 1 15 |
| Total | -- | -- | 1,857 | 739 | 195 |
Includes one citation for which abstract review could not be completed (full article review required; citation not received).
Note: Cataract trials database currently contains 195 records.
Citations deleted during abstract review process:
| Reason for Removal | Number of Citations |
|---|---|
| Both reviewers agreed to delete | 193 |
| Both reviewers agreed citation not applicable | 237 |
| One reviewer deleted, one said not applicable | 105 |
| Duplicates | 9 |
| TOTAL deleted during abstract review: | 544 |
See footnotes on next page.
Reviewers did not have to agree; total number of reasons will be more than the 544 citations deleted.
Includes three citations not received by end of article abstraction.
Reviewers may select multiple topics and need not agree on classification; number of citations by topic is, therefore, greater than total number of citations being reviewed in article review process.
Reasons for deletion:
| Reason for Deletion | Number of Citations1 |
|---|---|
| Fewer than 100 cases (for case series only) | 181 |
| Only address general anesthesia | 52 |
| No original data | 27 |
| Adults not part of study population | 25 |
| Did not address human data | 4 |
| Removed, not applicable | 237 |
| Other | 39 |
See footnotes on next page.
Reviewers did not have to agree; total number of reasons will be more than the 544 citations deleted.
Citations Kept (included in article review process)
| Total number kept: | 1952 |
| Classification by topic: | |
| Topic | Number of Citations3 |
|---|---|
| Regional anesthesia | 157 |
| Sedation | 45 |
| Patient characteristics | 2 |
| Regional anesthesia and sedation | 1 |
See footnotes on next page.
Includes three citations not received by end of article abstraction.
Reviewers may select multiple topics and need not agree on classification; number of citations by topic is, therefore, greater than total number of citations being reviewed in article review process.
Aboul-Eish E. Is general anaesthesia better than local analgesia for cataract extraction? Bull Ophthalmol Soc Egypt 1968;61(65):263-5.
Abrahamson IA, Scioville G. Intravenous diazepam as an adjunct to local anesthesia in ophthalmic surgery. Ann Ophthalmol 1975 Apr;7(4):567-70.
Ali-Melkkila TM, Virkkila M, Jyrkkio H. Regional anesthesia for cataract surgery: Comparison of retrobulbar and peribulbar techniques. Reg Anesth 1992 Jul;17(4):219-22.
Arnold PN. Prospective study of a single-injection peribulbar technique. J Cataract Refract Surg 1992 Mar;18(2):157-61.
Barker JP, Vafidis GC, Robinson PN, et al. Plasma catecholamine response to cataract surgery: A comparison between general and local anaesthesia. Anaesthesia 1991 Aug;46(8):642-5.
Barker JP, Vafidis GC, Hall GM. Postoperative morbidity following cataract surgery. A comparison of local and general anaesthesia. Anaesthesia 1996 May;51(5):435-7.
Behndig A, Linden C. Aqueous humor lidocaine concentrations in topical and intracameral anesthesia. J Cataract Refract Surg 1998 Dec;24(12):1598-601.
Beri S, Biswas NR, Shende DR, et al. Injectable centbucridine and lidocaine hydrochloride for intraocular surgery. Ophthalmic Surg Lasers 1997 Dec;28(12):1027-9.
Bloomberg LB, Pellican KJ. Topical anesthesia using the Bloomberg SuperNumb Anesthetic Ring. J Cataract Refract Surg 1995 Jan;21(1):16-20.
Brady MD, Hustead RR, Robinson RH, et al. Dilution of proparacaine in balanced salt solution reduces pain of anesthetic instillation in the eye. Reg Anesth 1994 May;19(3):196-8.
Brahma AK, Pemberton CJ, Ayeko M, et al. Single medial injection peribulbar anaesthesia using prilocaine. Anaesthesia 1994 Nov;49(11):1003-5.
Brydon CW, Basler M, Kerr WJ. An evaluation of two concentrations of hyaluronidase for supplementation of peribulbar anaesthesia. Anaesthesia 1995 Nov;50(11):998-1000.
Campbell DN, Lim M, Muir MK, et al. A prospective randomised study of local versus general anaesthesia for cataract surgery. Anaesthesia 1993 May;48(5):422-8.
Campbell IT, Sparrow CH, Duthie AM. Ophthalmic anaesthesia under gamma-hydroxybutyrate and local analgesia. A method for developing countries. Anaesthesia 1972 Jul;27(3): 319-26.
Chapu BA, Ahmed M, Dhar CL. Mandrax as a premedication in cataract surgery. Indian J Ophthalmol 1977 Apr;25(1):33-4.
Chopdar A. Sedation for cataract surgery. Comparison of Carbrital and neuroleptanalgesia. Br J Ophthalmol 1970 Oct;54(10):687-9.
Coelho ET, Gomes EB, Martins HS, et al. Prilocaine: An old anesthetic agent and a new ophthalmic procedure. Ophthalmic Surg 1993 Sep;24(9):612-6.
Crawford M, Kerr WJ. The effect of hyaluronidase on peribulbar block. Anaesthesia 1994 Oct;49(10):907-8.
Cummings AB, Konig HL. Effect of oxygen and air inhalation during cataract surgery on blood gas parameters. J Cataract Refract Surg 1996 Nov;22(9):1236-9.
Dempsey GA, Barrett PJ, Kirby IJ. Hyaluronidase and peribulbar block. Br J Anaesth 1997 Jun;78(6):671-4.
Erb T, Sluga M, Hampl KF, et al. Preoperative anxiolysis with minimal sedation in elderly patients: Bromazepam or clorazepate-dipotassium? Acta Anaesthesiol Scand 1998 Jan;42(1):97-101.
Fichman RA. Use of topical anesthesia alone in cataract surgery. J Cataract Refract Surg 1996 Jun;22(5):612-4.
Forrest JB, Lam L, Woo J, et al. Oxygen desaturation in elderly patients during cataract surgery. Can J Anaesth 1990 May;37(4 Pt 2):S50.
Forrest JB, Lam L, Woo J, et al. Recovery after neuroleptanalgesia for cataract surgery. Can J Anaesth 1990 May;37(4 Pt 2):S82.
Francis IC, Schumacher RS, Haylen MJ. Assisted local anaesthesia for cataract surgery (ALACS). Aust N Z J Ophthalmol 1987 Aug;15(3):185-91.
Ghanchi FD, Khan MY. Sublingual lorazepam as premedication in peribulbar anesthesia. J Cataract Refract Surg 1997 Dec;23(10):1581-4.
Gills JP, Rudisill JE. Bupivacaine in cataract surgery. Ophthalmic Surg 1974 Dec;5(4):67-70.
Hamilton RC. Retrobulbar block revisited and revised. J Cataract Refract Surg 1996 Nov;22(9):1147-50.
Hulquist CR. Painless wakeful peribulbar block achieved safely with a single transconjunctival injection. Ophthalmic Surg 1995 May;26(3):200-4.
Karhunen U, Jonn G. A comparison of memory function following local and general anaesthesia for extraction of senile cataract. Acta Anaesthesiol Scand 1982 Aug;26(4):291-6.
Kennerdell JS, Rydze D, Robertson M. Comparison of retrobulbar Marcaine and combined Marcaine-carbocaine in ophthalmic surgery. Ann Ophthalmol 1976 Oct;8(10):1236-40.
Laaka V, Nikki P, Tarkkanen A. Comparison of bupivacaine with and without adrenalin and mepivacaine with adrenalin in intraocular surgery. Acta Ophthalmol (Copenh) 1972;50(2):229-39.
Meyer D, Hamilton RC, Loken RG, et al. Effect of combined peribulbar and retrobulbar injection of large volumes of anesthetic agents on the intraocular pressure. Can J Ophthalmol 1992 Aug;27(5):230-2.
Neatrour GP, Lederman IR. Reducing fire hazard during ophthalmic surgery by using compressed air. Ophthalmic Surg 1989 Jun;20(6):430-2.
Nicoll JM, Treuren B, Acharya PA, et al. Retrobulbar anesthesia: The role of hyaluronidase. Anesth Analg 1986 Dec;65(12):1324-8.
Palve H, Ali-Melkkila T. Oxygenation during local anaesthesia for cataract surgery. Acta Anaesthesiol Scand 1991 Feb;35(2):181-4.
Polkinghorne PJ. Inadvertent perforation of the globe during regional anaesthesia. Aust N Z J Ophthalmol 1996 Feb;24(1):43-5.
Rauz S, Subramaniam S. Sub-Tenon's anesthesia and orbicularis oculi function. Ophthalmic Surg Lasers 1997 Sep;28(9):727-30.
Rinkoff JS, Doft BH, Lobes LA. Management of ocular penetration from injection of local anesthesia preceding cataract surgery. Arch Ophthalmol 1991 Oct;109(10):1421-5.
Risdall JE, Geraghty IF. Oxygenation of patients undergoing ophthalmic surgery under local anaesthesia. Anaesthesia 1997 May;52(5):492-5.
Roman SJ, Chong Sit DA, Boureau CM, et al. Sub-Tenon's anaesthesia: an efficient and safe technique. Br J Ophthalmol 1997 Aug;81(8):673-6.
Sanford DK, Minoso Y, Belyea DA. Response of intraocular pressure to retrobulbar and peribulbar anesthesia. Ophthalmic Surg Lasers 1998 Oct;29(10):815-7.
Suzuki R, Kawata K, Kuroki S, et al. A comparison of blood pressure changes in phacoemulsification surgery with topical and retrobulbar block local anesthesia: Part II. Ophthalmologica 1997;211(6):327-31.
Suzuki R, Kuroki S, Fujiwara N, et al. The effects of phacoemulsification cataract surgery via local anesthesia on preoperative and postoperative blood pressure levels. Ophthalmology 1997 Feb;104(2):216-22.
Teichmann KD, Uthoff D. Retrobulbar (intraconal) anesthesia with a curved needle: Technique and results. J Cataract Refract Surg 1994 Jan;20(1):54-60.
van Rij G, Renardel de Lavalette JG, Baarsma GS, et al. Effect of oxybuprocaine 0.4% in preventing surgically induced miosis. Br J Ophthalmol 1984 Apr;68(4):248-51.
Virkkila M, Ali-Melkkila T, Soini H, et al. Pharmacokinetics and effects of i.m. alfentanil as premedication for day-case ophthalmic surgery in elderly patients. Br J Anaesth 1993 Oct;71(4):507-11.
Walker AK. Neuroleptanalgesia for intra-ocular surgery: experience in a developing country. Anaesthesia 1976 Jun;31(5):690-4.
Walters G, McKibbin M. The value of pre-operative investigations in local anaesthetic ophthalmic surgery. Eye 1997;11(Pt 6):847-9.
Wang HS. Peribulbar anesthesia for ophthalmic procedures. J Cataract Refract Surg 1988 Jul;14(4):441-3.
Wood G, Simpson T. The effect of hyaluronidase on the speed of onset of retrobulbar anaesthesia. Can J Anaesth 1990 May;37(4 Pt 2):S62.
| Reason for Exclusion | Percent of Excluded Articles (N=51) |
|---|---|
| Did not address human data | 0.0 |
| Did not address anesthesia management for cataract surgery | 3.8 |
| Did not report data separately for cataract surgery | 28.9 |
| Only addressed general anesthesia | 0.0 |
| Adults were not part of the population studied | 0.0 |
| No original data | 9.6 |
| Was not controlled trial or case series > 100 patients | 19.2 |
| Data not extractable as reported | 3.8 |
| Meeting abstract | 5.7 |
| Outcomes reported not directly relevant to study priorities | 17.3 |
| Regional anesthesia technique reported not relevant to 1999 | 1.9 |
| Sedation technique reported not relevant to 1999 | 9.6 |
| Variable | Baseline value | Plausible range |
|---|---|---|
| Cost of admission | $595 | $500-700 |
| Anesthesiologist cost | $100 | $75-150 |
| Anesthesiologist cost, on call | $25 | $9.30-37.50 |
| Cost of conversion from topical to block anesthesia | $5 | $1-9 |
| Cost of general anesthesia | $50 | $25-150 |
| Cost of anesthesia supplies | $65 | $20-100 |
| Cost of preoperative tests | $120 | $70-180 |
| Cost of treating intraoperative cardiovascular instability | $5 | $1-9 |
| Cost of treating postoperative nausea and vomiting | $15 | $10-20 |
| Cost of oral sedation | $5 | $1-9 |
| Cost of intravenous sedation | $30 | $15-50 |
| Cost of topical anesthesia (including intracameral block) | $5 | $1-9 |
| Cost of peribulbar or retrobulbar block anesthesia | $5 | $1-9 |
In the decision model, the overall preference value for situations where one or more complications occurred was determined by multiplying the baseline preference of the anesthesia management strategy by the disutility factor(s) of the complication(s) that occurred. Disutility factors represent the preference value assigned to a scenario with a complication divided by the preference value assigned to a scenario without the complication.
The lowest value of the plausible range for a given disutility factor was based on the lowest disutility factor assigned by an expert to the complication, and the highest value of the plausible range was based on the highest value assigned by an expert.
| Baseline scenarios for anesthesia management | Preference value | Plausible range |
|---|---|---|
| Baseline scenarios for anesthesia management | Preference value | Plausible range |
| Block anesthesia with intravenous sedation administered by an anesthesiologist | 0.89 | 0.80-0.98 |
| Topical anesthesia with intravenous sedation administered by an anesthesiologist | 0.66 | 0.30-0.95 |
| Block anesthesia with oral sedation preoperatively, with an anesthesiologist on call for additional sedation | 0.75 | 0.50-0.95 |
| Block anesthesia with oral sedation preoperatively, with no anesthesiologist on call for additional sedation | 0.62 | 0.20-0.85 |
| Topical anesthesia with oral sedation preoperatively, with an anesthesiologist on call for additional sedation | 0.56 | 0.10-0.90 |
| Topical anesthesia with oral sedation preoperatively, with no anesthesiologist on call for additional sedation | 0.50 | 0.50-0.90 |
| Complication | Disutility factor1 | Plausible range2 |
|---|---|---|
| Complication | Disutility factor1 | Plausible range2 |
| Being admitted postoperatively | 0.63 | 0.31-0.80 |
| Being converted from topical to block anesthesia | 0.90 | 0.42-0.94 |
| Experiencing cardiovascular instability intraoperatively | 0.81 | 0.71-0.90 |
| Being converted to general anesthesia from block anesthesia | 0.47 | 0.30-0.55 |
| Being converted from topical anesthesia to general anesthesia | 0.86 | 0.44-1.0 |
| Experiencing nausea and vomiting postoperatively | 0.72 | 0.42-0.75 |
In the decision model, the overall preference value for situations where one or more complications occurred was determined by multiplying the baseline preference of the anesthesia management strategy by the disutility factor(s) of the complication(s) that occurred. Disutility factors represent the preference value assigned to a scenario with a complication divided by the preference value assigned to a scenario without the complication.
The lowest value of the plausible range for a given disutility factor was based on the lowest disutility factor assigned by an expert to the complication, and the highest value of the plausible range was based on the highest value assigned by an expert.
| Variable | Baseline value | Plausible range |
|---|---|---|
| Probability of admission postsurgery with intravenous sedation | 0.006 | 0.0047-0.0072 |
| Probability of admission postsurgery with oral sedation | 0.0098 | 0.003-0.017 |
| Probability of being converted from topical to block anesthesia | 0.06 | 0.02-0.1 |
| Probability of being converted to general anesthesia from initial intravenous sedation | 0.0036 | 0.0001-0.1 |
| Probability of being converted to general anesthesia from initial oral sedation and topical anesthesia | 0.0065 | 0.0001-0.03 |
| Probability of experiencing cardiovascular instability intraoperatively while receiving intravenous sedation | 0.0277 | 0.0251-0.0304 |
| Probability of experiencing cardiovascular instability intraoperatively while receiving oral sedation | 0.0125 | 0.0067-0.0206 |
| Probability of nausea and vomiting postoperatively after having received intravenous sedation intraoperatively | 0.044 | 0.0408-0.0475 |
| Probability of nausea and vomiting postoperatively after having received oral sedation intraoperatively | 0.0347 | 0.0213-0.0481 |
| Rank (lowest to highest cost) | Strategy | Expected cost |
|---|---|---|
| 1 | Strategy 3 (block anesthesia with oral sedation preoperatively, with no anesthesiologist on call for additional sedation) | $17.16 |
| 2 | Strategy 6 (topical anesthesia with oral sedation preoperatively, with no anesthesiologist on call for additional sedation) | $17.46 |
| 3 | Strategy 2 (block anesthesia with oral sedation preoperatively, with an anesthesiologist on call for additional sedation) | $42.16 |
| 4 | Strategy 5 (topical anesthesia with oral sedation preoperatively, with an anesthesiologist on call for additional sedation) | $42.46 |
| 5 | Strategy 1 (block anesthesia with intravenous sedation administered by an anesthesiologist) | $324.55 |
| 6 | Strategy 4 (topical anesthesia with intravenous sedation administered by an anesthesiologist) | $324.85 |
| Rank (greatest to least utility) | Strategy | Expected net preference value |
|---|---|---|
| 1 | Strategy 1 (block anesthesia with intravenous sedation administered by an anesthesiologist) | 0.874 |
| 2 | Strategy 2 (block anesthesia with oral sedation preoperatively, with an anesthesiologist on call for additional sedation) | 0.736 |
| 3 | Strategy 4 (topical anesthesia with intravenous sedation administered by an anesthesiologist) | 0.644 |
| 4 | Strategy 3 (block anesthesia with oral sedation preoperatively, with no anesthesiologist on call for additional sedation) | 0.603 |
| 5 | Strategy 5 (topical anesthesia with oral sedation preoperatively, with an anesthesiologist on call for additional sedation) | 0.550 |
| 6 | Strategy 6 (topical anesthesia with oral sedation preoperatively, with no anesthesiologist on call for additional sedation) | 0.484 |
| Procedure | Inpatient hospital | Outpatient hospital | Ambulatory surgery center | Office-based surgery |
|---|---|---|---|---|
| Procedure | Inpatient hospital | Outpatient hospital | Ambulatory surgery center | Office-based surgery |
| Number of procedures | 1,754 | 81,643 | 52,414 | 2,773 |
| Readmission within 1 day of surgery (per 1,000 cases) | 15.39 | 1.34 | 1.05 | 2.88 |
| Readmission within 7 days of surgery (per 1,000 cases) | 19.95 | 3.56 | 2.82 | 4.69 |
| Risk factor | P value | Odds ratio |
|---|---|---|
| Risk factor | P value | Odds ratio |
| Age 80-84 | <0.01 | 1.209 |
| Age > 85 | <0.01 | 1.645 |
| Female | 0.02 | 0.889 |
| Prior admission to a hospital | <0.01 | 1.754 |
| Charleson Index | <0.01 | 1.083 |
| Inpatient hospital | <0.01 | 2.54 |
| Ambulatory surgery center | <0.01 | 0.849 |
| Office-based setting | 0.144 | 1.26 |
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