Shanghai Municipal Hospital of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine, Shanghai, 200071, China.
Shanghai Jingan District Zhabei Central Hospital, Shanghai, 200070, China.
Trials. 2020 Feb 11;21(1):163. doi: 10.1186/s13063-020-4064-2.
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.
背景:鼻内镜手术后常见的是术后疼痛。它会干扰睡眠质量,并延迟术后恢复。针灸是疼痛管理的有效工具。然而,专门针对鼻内镜手术后缓解术后疼痛的电针对尚未在随机对照试验中进行研究。
方法/设计:本随机假对照患者和评估者盲法试验旨在评估电针对治疗鼻息肉引起的鼻窦炎的鼻内镜手术后管理术后疼痛的疗效和安全性。总共将有 30 名参与者以 1:1 的比例随机分配到电针或非侵入性假对照组。治疗将在手术前 2 小时内、手术后立即到达恢复病房时以及每天一次进行 3 天。主要结局是疼痛数字评分量表,将使用曲线下面积进行分析。次要结局指标包括手术后的心率和血压、住院期间的睡眠质量(活动记录仪)、恢复质量以及 36 项简短健康调查。本试验将采用意向治疗分析。
讨论:本试验的随机对照试验将探索电针对管理术后疼痛的进一步临床应用的可行性。它将为进一步的全面试验设计提供信息。
试验注册:中国临床试验注册中心,ChiCTR1900024183。于 2019 年 6 月 29 日注册。
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