Bilateral erector spinae plane block on opioid-sparing effect in upper abdominal surgery: study protocol for a bi-center prospective randomized controlled trial.

IF 2 4区医学 Q3 MEDICINE, RESEARCH & EXPERIMENTAL Trials Pub Date : 2024-11-13 DOI:10.1186/s13063-024-08612-w

Changzhen Geng, Li Wang, Yaping Shi, Xinnan Shi, Hanyi Zhao, Ya Huang, Qiufang Ji, Yuanqiang Dai, Tao Xu

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Abstract

Background: Erector spinae plane block (ESPB) is a promising technique for effective analgesia. It is still uncertain if ESPB offers the same opioid-sparing effect as thoracic paravertebral block (PVB) in midline incision for upper abdominal surgery.

Methods: The study is a prospective, bi-center, randomized, controlled, non-inferior trial. One hundred fifty-eight patients scheduled for upper abdominal surgery will be randomly assigned to receive bilateral ESPB or PVB before surgery. The primary outcome will be the equivalent cumulative analgesia dosage of sufentanil during the surgery, which is defined as the total dosage of sufentanil from anesthesia induction to tracheal extubation. The main secondary outcomes include postoperative complications and the quality of recovery-15 score at 24 h, 48 h, and 30 days after surgery.

Discussion: This study will assess the opioid-sparing efficacy of ESPB and PVB, complications, and the quality of recovery of two blocks.

Trial registration: ChiCTR2300073030 ( https://www.chictr.org.cn/ ). Registered on 30 June 2023.

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上腹部手术中双侧竖脊肌平面阻滞对阿片类药物节约效果的影响：双中心前瞻性随机对照试验的研究方案。

背景：脊柱后凸面阻滞（ESPB）是一种很有前途的有效镇痛技术。在上腹部手术的中线切口中，ESPB是否能提供与胸椎旁阻滞（PVB）相同的阿片类药物节省效果，目前仍不确定：该研究是一项前瞻性、双中心、随机对照、非劣效试验。158 名计划接受上腹部手术的患者将被随机分配到接受双侧 ESPB 或 PVB。主要结果是手术期间舒芬太尼的等效累积镇痛剂量，即从麻醉诱导到气管拔管期间舒芬太尼的总剂量。主要次要结果包括术后并发症和术后24小时、48小时和30天的恢复质量-15评分：本研究将评估ESPB和PVB两种阻滞的阿片类药物节省效果、并发症和恢复质量：ChiCTR2300073030 ( https://www.chictr.org.cn/ )。注册日期：2023年6月30日。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Trials 医学-医学：研究与实验

CiteScore

3.80

自引率

4.00%

发文量

966

审稿时长

6 months

期刊介绍： Trials is an open access, peer-reviewed, online journal that will encompass all aspects of the performance and findings of randomized controlled trials. Trials will experiment with, and then refine, innovative approaches to improving communication about trials. We are keen to move beyond publishing traditional trial results articles (although these will be included). We believe this represents an exciting opportunity to advance the science and reporting of trials. Prior to 2006, Trials was published as Current Controlled Trials in Cardiovascular Medicine (CCTCVM). All published CCTCVM articles are available via the Trials website and citations to CCTCVM article URLs will continue to be supported.