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超声引导下胸腰段筋膜平面阻滞联合全身麻醉与单纯全身麻醉对接受选择性后根切断术的脑瘫患儿苏醒期躁动的影响:一项随机对照临床试验方案

Effects of ultrasound-guided thoracolumbar interfascial plane block combined with general anaesthesia versus general anaesthesia alone on emergence agitation in children with cerebral palsy undergoing selective posterior rhizotomy: protocol for a randomised controlled clinical trial.

作者信息

Li Xueyang, Huang Xiao, Xu Kai, Zan Jingwei, Liu Guokai, Sun Yuan, Ren Huilong

机构信息

Department of Anesthesiology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.

Department of Anesthesiology, Dongzhimen Hospital, Beijing University of Chinese Medicine, Beijing, China.

出版信息

BMJ Open. 2024 Aug 7;14(8):e082533. doi: 10.1136/bmjopen-2023-082533.

Abstract

INTRODUCTION

Selective posterior rhizotomy (SPR) is a preferred procedure for relieving spastic children with cerebral palsy, but it is associated with severe pain and significant emergence agitation (EA). The thoracolumbar interfascial plane (TLIP) block provides an effective blockade to the dorsal branch of the spinal nerve. We hypothesise that the TLIP block may be an effective tool to alleviate EA and postoperative pain scores in children with cerebral palsy undergoing SPR.

METHODS AND ANALYSIS

This study is a single-centre, randomised, parallel-controlled trial being conducted in Beijing, China. A total of 50 paediatric patients with cerebral palsy scheduled for SPR are randomised in a 1:1 ratio to receive bilateral TLIP block with 0.2% ropivacaine 0.5 mL/kg or control. Patients in the TLIP group receive general anaesthesia combined with TLIP block, while patients in the control group receive only general anaesthesia, without a TLIP block. The primary outcome is the Paediatric Anaesthesia Emergence Delirium Score. The secondary outcomes are the incidence of EA, the Wong-Baker Faces Pain-rating Scale, the perioperative haemodynamics, the intraoperative remifentanil and propofol dosage, the extubation time and recovery time, and adverse reactions.

ETHICS AND DISSEMINATION

This study was approved by the Ethics Committee of Dongzhimen Hospital, Beijing University of Chinese Medicine on 21 September 2023 (2023DZMEC-379-02). Written informed consent is obtained from the legal guardian of each patient. The results of this study will be published in peer-reviewed international journals.

TRIAL REGISTRATION NUMBER

ChiCTR2300076397.

摘要

引言

选择性后根切断术(SPR)是缓解痉挛型脑瘫患儿症状的首选手术,但该手术会引发严重疼痛和明显的苏醒期躁动(EA)。胸腰段筋膜间平面(TLIP)阻滞可有效阻滞脊神经后支。我们推测,TLIP阻滞可能是减轻接受SPR手术的脑瘫患儿EA及术后疼痛评分的有效方法。

方法与分析

本研究是在中国北京进行的一项单中心、随机、平行对照试验。共有50例计划接受SPR手术的脑瘫患儿按1:1比例随机分组,分别接受双侧0.2%罗哌卡因0.5 mL/kg的TLIP阻滞或对照组处理。TLIP组患者接受全身麻醉联合TLIP阻滞,而对照组患者仅接受全身麻醉,不进行TLIP阻滞。主要观察指标为小儿麻醉苏醒期谵妄评分。次要观察指标包括EA的发生率、面部表情疼痛评分量表、围手术期血流动力学、术中瑞芬太尼和丙泊酚用量、拔管时间和恢复时间以及不良反应。

伦理与传播

本研究于2023年9月21日获得北京中医药大学东直门医院伦理委员会批准(2023DZMEC - 379 - 02)。已获得每位患者法定监护人的书面知情同意。本研究结果将发表在同行评审的国际期刊上。

试验注册号

ChiCTR2300076397。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3e8f/11404198/8a6885195894/bmjopen-14-8-g001.jpg

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