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Trials. 2020 Feb 11;21(1):163. doi: 10.1186/s13063-020-4064-2.

Electroacupuncture for postoperative pain after nasal endoscopic surgery: study protocol for a pilot randomized controlled trial.

Author information

1
Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200071, China.
2
Shanghai Jingan District Zhabei Central Hospital, Shanghai, 200070, China.
3
Department of Biostatistics, School of Public Health, Fudan University, Shanghai, 200032, China.
4
School of Chinese Medicine, The University of Hong Kong, Hong Kong, China.
5
Virginia University of Integrative Medicine, Fairfax, VA, 22031, USA.
6
Shanghai Research Institute of Acupuncture and Meridian, Shanghai University of Traditional Chinese Medicine, Shanghai, 200030, China. wuhuangan@126.com.
7
Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200071, China. xu_teacher2006@126.com.

Abstract

BACKGROUND:

Postoperative pain is common after nasal endoscopic surgery. It interferes with the quality of sleep and delays postoperative recovery. Acupuncture is an effective tool for pain management. However, electroacupuncture specifically for the relief of postoperative pain after nasal endoscopic surgery has not yet been studied in a randomized controlled trial.

METHODS/DESIGN:

This randomized sham-controlled patient- and assessor-blind pilot trial has been designed to evaluate the efficacy and safety of electroacupuncture in managing postoperative pain following nasal endoscopic surgery to treat sinusitis due to nasal polyps. Altogether, 30 participants will be randomly allocated to an electroacupuncture or non-invasive sham control in a 1:1 ratio. Treatment will occur within 2 h before the operation, immediately after the operation upon arrival in the recovery ward, and once daily for 3 days. The primary outcome is the pain numerical rating scale, which will be analyzed using the area under the curve. The secondary outcome measures include heart rate and blood pressure after the operation, sleep quality during the hospital stay (actigraph), quality of recovery, and the 36-item short form health survey. This trial will use an intention-to-treat analysis.

DISCUSSION:

This pilot randomized controlled trial will explore the feasibility of the further clinical application of electroacupuncture for the management of postoperative pain. It will inform the design of a further full-scale trial.

TRIAL REGISTRATION:

Chinese Clinical Trial Registry, ChiCTR1900024183. Registered on 29 June 2019.

KEYWORDS:

Electroacupuncture; RCT; clinical trial; nasal endoscopic surgery; postoperative pain; randomized controlled trial

PMID:
32046764
DOI:
10.1186/s13063-020-4064-2
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