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Complementary medicine
Protocol
Electroacupuncture to alleviate postoperative pain after a laparoscopic appendectomy: study protocol for a three-arm, randomised, controlled trial
  1. Seunghoon Lee1,
  2. Dongwoo Nam1,2,
  3. Minsoo Kwon1,
  4. Won Seo Park3,4,
  5. Sun Jin Park3,4
  1. 1 Department of Acupuncture and Moxibustion Medicine, Kyung Hee University Korean Medicine Hospital, Seoul, South Korea
  2. 2 Department of Acupuncture and Moxibustion, College of Korean Medicine, Kyung Hee University, Seoul, South Korea
  3. 3 Department of Surgery, Kyung Hee University Hospital, Seoul, South Korea
  4. 4 Department of Surgery, Kyung Hee University School of Medicine, Seoul, South Korea
  1. Correspondence to Professor Sun Jin Park; gsdrpark{at}naver.com

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).

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

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2016-015286

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    Footnotes

    • Contributors SL and SJP planned the overall study protocol. SL drafted the manuscript. SL, DN, MK, WSP and SJP participated in critical revision of the manuscript. SJP had the final responsibility for the decision to submit for publication. All of the authors have read and approved the final manuscript.

    • Funding This work was supported by a grant from Kyung Hee University in 2014 (KHU-20140706).

    • Competing interests None declared.

    • Patient consent Obtained.

    • Ethics approval The institutional review board (IRB) of Kyung Hee University Medical Center (KMC IRB-1427-02).

    • Provenance and peer review Not commissioned; externally peer reviewed.

    • Data sharing statement We will share the data after the trial is finished. The full data set will be available by an author contact when this trial is completed and published.