Format

Send to

Choose Destination
J Pain. 2019 Mar 4. pii: S1526-5900(18)30519-4. doi: 10.1016/j.jpain.2019.02.010. [Epub ahead of print]

Perioperative pregabalin and intraoperative lidocaine infusion to reduce persistent neuropathic pain after breast cancer surgery: a multicenter, factorial, randomized controlled pilot trial.

Author information

1
Department of Anesthesia, University of Toronto, Toronto, Ontario, Canada. Electronic address: james.khan@medportal.ca.
2
Department of Surgery, McMaster University, Hamilton, Ontario, Canada.
3
Department of Anesthesia, University of Toronto, Toronto, Ontario, Canada; Sunnybrook Health Sciences Center, Toronto, Ontario, Canada.
4
Department of Anesthesia, McMaster University, Hamilton, Ontario, Canada.
5
Sunnybrook Health Sciences Center, Toronto, Ontario, Canada; Department of Surgery, University of Toronto, Toronto, Ontario, Canada.
6
Department of Anesthesia, McMaster University, Hamilton, Ontario, Canada; Michael G. DeGroote Institute for Pain Research and Care, McMaster University, Hamilton, Ontario, Canada; Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada.
7
Department of Anesthesiology & Perioperative Medicine, Queen's University, Kingston, Ontario, Canada.
8
Department of Anesthesia, McMaster University, Hamilton, Ontario, Canada; Michael G. DeGroote Institute for Pain Research and Care, McMaster University, Hamilton, Ontario, Canada.
9
Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada; School of Nursing, McMaster University, Hamilton, Ontario, Canada.
10
Department of Anesthesia, University of Toronto, Toronto, Ontario, Canada; Toronto General Hospital, University Health Network, Toronto, Ontario, Canada.
11
Department of Anesthesia, University of Toronto, Toronto, Ontario, Canada; Department of Psychology, York University, Toronto, Ontario, Canada.
12
Division of Pain Medicine, Department of Anesthesiology, Perioperative, and Pain Medicine, Stanford University, Palo Alto, California, USA.
13
Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada.
14
Department of Health Research Methods, Evidence and Impact, McMaster University, Hamilton, Ontario, Canada; Population Health Research Institute, McMaster University, Hamilton, Ontario, Canada; Department of Medicine, McMaster University, Hamilton, Ontario, Canada.

Abstract

Persistent post-surgical pain is defined as pain localized to the area of surgery of at least 2-month duration and is unfortunately a common complication after breast cancer surgery. While there is insufficient evidence to support any preventative strategy, prior literature suggests possible efficacy of intravenous lidocaine and perioperative pregabalin in preventing persistent pain after surgery. To determine feasibility of conducting a larger definitive trial, we conducted a multicenter 2-by-2 factorial randomized placebo-controlled pilot trial of 100 female patients undergoing breast cancer surgery. Patients were randomized to receive an intraoperative lidocaine infusion (1.5 mg/kg bolus followed by 2 mg/kg/hr) or placebo and perioperative pregabalin (300 mg preoperatively, 75 mg twice daily for nine days) or placebo. All feasibility criteria were surpassed; recruitment of 100 patients within 42-weeks, follow-up rate of 100%, and study-drug compliance of ≥80%. At 3-months, 53% of patients reported persistent neuropathic pain. While there was no interaction between lidocaine and pregabalin, lidocaine reduced the development of persistent neuropathic pain (43.1% vs 63.3%; RR 0.68, 95% CI 0.47-1.0). Pregabalin did not reduce persistent pain (60% vs 46%; RR 1.3, 95% CI 0.90 to 1.90) and neither pregabalin nor lidocaine impacted acute postoperative pain, opioid consumption, pain interference, or quality of life. Our pilot trial successfully demonstrated feasibility and provided promising data for conducting further trials of intraoperative lidocaine infusions in breast cancer surgeries. Clinical trial number: NCT02240199 Perspectives: This article reports the findings of a pilot randomized controlled trial evaluating the effects of perioperative pregabalin and intraoperative lidocaine infusions in patients undergoing breast cancer surgery. This trial demonstrated feasibility of conducting a larger trial and provided promising data that these interventions may reduce the development of persistent pain.

KEYWORDS:

acute pain; chronic pain; clinical trial; pain; perioperative; surgery

Supplemental Content

Full text links

Icon for Elsevier Science
Loading ...
Support Center