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BMJ Open. 2017 Aug 4;7(8):e015286. doi: 10.1136/bmjopen-2016-015286.

Electroacupuncture to alleviate postoperative pain after a laparoscopic appendectomy: study protocol for a three-arm, randomised, controlled trial.

Lee S1, Nam D1,2, Kwon M1, Park WS3,4, Park SJ3,4.

Author information

1
Department of Acupuncture and Moxibustion Medicine, Kyung Hee University Korean Medicine Hospital, Seoul, South Korea.
2
Department of Acupuncture and Moxibustion, College of Korean Medicine, Kyung Hee University, Seoul, South Korea.
3
Department of Surgery, Kyung Hee University Hospital, Seoul, South Korea.
4
Department of Surgery, Kyung Hee University School of Medicine, Seoul, South Korea.

Abstract

BACKGROUND:

The purpose of this study is to evaluate the efficacy and safety of electroacupuncture (EA) for postoperative pain after laparoscopic appendectomy compared with sham electroacupuncture (SEA) and no acupuncture treatment.

METHODS AND ANALYSIS:

This study is a protocol for a three-arm, randomised, patient-assessor-blinded (to the type of acupuncture treatment), controlled, parallel trial. 138 participants diagnosed with appendicitis and scheduled for laparoscopic appendectomy will be randomly assigned to the EA group (n=46), SEA group (n=46) or control group (n=46). The EA group will receive acupuncture treatment at both regional and distal acupuncture points with electrostimulation. The SEA group will receive sham acupuncture treatment with mock electrostimulation. Both EA and SEA groups will receive a total of four treatments 1 hour preoperative, 1 hour postoperative and during the morning and afternoon the day after surgery with the same routine postoperative pain control. The control group will receive only routine postoperative pain control. The primary outcome is the 11-point Pain Intensity Numerical Rating Scale (PI-NRS) at 24 hours after surgery. The secondary outcomes are the PI-NRS, analgesic consumption, opioid-related side effects, time to first passing flatus, quality of life and adverse events evaluated 6, 12, 24 and 36 hours and 7 days after surgery.

ETHICS AND DISSEMINATION:

The study was planned in accordance with the Helsinki Declaration and the Korean Good Clinical Practice Guidelines to protect the participants and was approved by the institutional review board (IRB) of Kyung Hee University Medical Center (KMC IRB-1427-02). The results will be disseminated in peer-reviewed journals and presented at international conferences.

TRIAL REGISTRATION NUMBER:

Clinical Research Information Service (KCT0001328).

KEYWORDS:

appendectomy; appendicitis; electroacupuncture; laparoscopy; postoperativepain; randomised controlled trial

PMID:
28780543
PMCID:
PMC5724078
DOI:
10.1136/bmjopen-2016-015286
[Indexed for MEDLINE]
Free PMC Article

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