关键词: Clinical Trial Paediatric anaesthesia Pain management

Mesh : Humans Cerebral Palsy / complications surgery Anesthesia, General / methods Nerve Block / methods Child Rhizotomy / methods Emergence Delirium Ultrasonography, Interventional / methods Pain, Postoperative / drug therapy prevention & control Male Ropivacaine / administration & dosage therapeutic use Female Child, Preschool Randomized Controlled Trials as Topic Anesthetics, Local / administration & dosage China Adolescent

来  源:   DOI:10.1136/bmjopen-2023-082533

Abstract:
BACKGROUND: 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: 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.
BACKGROUND: 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.
BACKGROUND: ChiCTR2300076397.
摘要:
背景:选择性后根切断术(SPR)是缓解痉挛的脑瘫患儿的首选方法,但它与严重疼痛和明显的出现躁动(EA)有关。胸腰椎筋膜平面(TLIP)阻滞可有效阻断脊神经的背支。我们假设TLIP阻滞可能是缓解接受SPR的脑瘫患儿EA和术后疼痛评分的有效工具。
方法:本研究是单中心,随机化,在北京进行的平行对照试验,中国。总共50名计划进行SPR的小儿脑瘫患者以1:1的比例随机分配,接受0.2%罗哌卡因0.5mL/kg的双侧TLIP阻滞或对照。TLIP组患者接受全麻联合TLIP阻滞,而对照组患者仅接受全身麻醉,没有TLIP块。主要结果是小儿麻醉出现谵妄评分。次要结果是EA的发生率,Wong-Baker面临疼痛评定量表,围手术期血流动力学,术中瑞芬太尼和丙泊酚的用量,拔管时间和恢复时间,和不良反应。
背景:本研究经东直门医院伦理委员会批准,北京中医药大学,2023年9月21日(2023DZMEC-379-02)。书面知情同意书从每个患者的法定监护人获得。这项研究的结果将发表在同行评审的国际期刊上。
背景:ChiCTR2300076397。
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