脂质体布比卡因与罗哌卡因加两种辅助剂用于电视辅助胸腔镜手术的前锯肌平面阻滞的疗效和安全性：一项单中心、随机、双盲试验方案

Efficacy and safety of liposomal bupivacaine versus ropivacaine with two adjuncts in serratus anterior plane block for video-assisted thoracoscopic surgery: a protocol for a single-centre, randomised, double-blinded trial.

作者信息

Yang Ziwei, Li Siyue, Shen Mengting, Lei Weiping, Huang Yaqin, Sun Jianliang, Cheng Yuan, Lu Xinlei

机构信息

Department of Anaesthesiology, Affiliated Hangzhou First People's Hospital, School of Medicine, Westlake University, Hangzhou, China.

Zhejiang University School of Medicine, Hangzhou First People's Hospital, Hangzhou, China.

出版信息

BMJ Open. 2025 Sep 17;15(9):e102326. doi: 10.1136/bmjopen-2025-102326.

DOI:10.1136/bmjopen-2025-102326

PMID:40967653

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12458678/

Abstract

INTRODUCTION

Ultrasound-guided serratus anterior plane block (SAPB) is commonly used for postoperative pain management in video-assisted thoracoscopic surgery (VATS). However, the choice of local anaesthetics for SAPB remains controversial. This study aims to compare the efficacy and safety of liposomal bupivacaine versus ropivacaine combined with two local anaesthetic adjuncts (dexamethasone and dexmedetomidine) for postoperative pain relief in VATS patients.

METHODS AND ANALYSIS

This is a single-centre, double-blinded, randomised controlled trial conducted at the Hangzhou First People's Hospital Affiliated to Westlake University School of Medicine in Hangzhou, China. A total of 120 adult patients scheduled for VATS will be randomly assigned in a 1:1:1 ratio to one of the following three groups: liposomal bupivacaine (group L), ropivacaine combined with dexamethasone (group D) and ropivacaine combined with dexmedetomidine (group R). The primary outcome is the Numeric Rating Scale pain score at rest at 24, 48 and 72 hours postoperatively. Secondary outcomes include opioid consumption, adverse events, Quality of Recovery-15 scores, patient satisfaction and length of hospital stay.

ETHICS AND DISSEMINATION

The study was approved by the Ethics Committee of the Hangzhou First People's Hospital Affiliated to Westlake University School of Medicine (approval number IIT-2024405-01) on 6 November 2024. The protocol was registered in the Chinese Clinical Trial Registry on 9 January 2025. The planned study period is from 1 January 2025 to 31 December 2027, with participant recruitment scheduled from 1 March 2025 to 31 December 2026. Recruitment has not yet started. All participants will provide written informed consent. The results will be disseminated through peer-reviewed journals and academic conferences.

TRIAL REGISTRATION NUMBER

ChiCTR2500095609.

摘要

引言

超声引导下前锯肌平面阻滞（SAPB）常用于电视胸腔镜手术（VATS）后的疼痛管理。然而，SAPB局部麻醉药的选择仍存在争议。本研究旨在比较脂质体布比卡因与罗哌卡因联合两种局部麻醉辅助药物（地塞米松和右美托咪定）在VATS患者术后镇痛中的疗效和安全性。

方法与分析

这是一项在中国杭州西湖大学医学院附属杭州市第一人民医院进行的单中心、双盲、随机对照试验。总共120例计划接受VATS的成年患者将按1:1:1的比例随机分配到以下三组之一：脂质体布比卡因组（L组）、罗哌卡因联合地塞米松组（D组）和罗哌卡因联合右美托咪定组（R组）。主要结局是术后24、48和72小时静息时的数字评定量表疼痛评分。次要结局包括阿片类药物消耗量、不良事件、恢复质量-15评分、患者满意度和住院时间。

伦理与传播

该研究于2024年11月6日获得西湖大学医学院附属杭州市第一人民医院伦理委员会批准（批准号IIT-2024405-01）。该方案于2025年1月9日在中国临床试验注册中心注册。计划研究期为2025年1月1日至2027年12月31日，参与者招募计划于2025年3月1日至2026年12月31日进行。招募尚未开始。所有参与者将提供书面知情同意书。研究结果将通过同行评审期刊和学术会议进行传播。