竖脊肌平面阻滞与椎旁神经阻滞在 Nuss 手术后患儿术后镇痛中的比较：一项随机对照非劣效性临床试验研究方案。
Comparison of erector spinae plane and paravertebral nerve blocks for postoperative analgesia in children after the Nuss procedure: study protocol for a randomized controlled non-inferiority clinical trial.
机构信息
Department of Anesthesiology and National Clinical Research Center for Geriatrics, West China Hospital of Sichuan University, Chengdu, Sichuan Province, China.
Department of Biomedical Engineering, Northwestern University, Evanston, IL, USA.
出版信息
Trials. 2022 Feb 14;23(1):139. doi: 10.1186/s13063-022-06044-y.
BACKGROUND
Thoracic paravertebral block (TPVB) is a widely advocated regional technique for alleviating postoperative pain in children undergoing elective pectus excavatum repair. However, this technique is associated with some undesirable adverse events. Recently, the erector spinae plane block (ESPB) has been introduced as a practical alternative to the TPVB in thoracic surgery. This interfascial regional anesthesia technique interrupts pain sensation by injecting local anesthetics between the muscular layers of the thoracic wall. Several case series described it as an effective pain management technique following pectus excavatum repair. Therefore, this trial is designed to test the hypothesis that ESPB is non-inferior to TPVB in postoperative pain control after pectus excavatum repair.
METHODS
This is a prospective randomized double-blind non-inferiority trial. A total of 40 patients aged 4 to 18 years undergoing Nuss surgery will be randomly assigned to receive pain treatment with either ESPB or TPVB. All patients will receive additional systemic multimodal analgesia with an intravenous patient-controlled analgesia pump and acetaminophen. The primary outcome is the pain intensity at rest, 24 h postoperatively. Secondary outcomes include accumulated morphine-equivalent consumption, postoperative pain scores, emergence agitation incidence, time of the first mobilization, time to first rescue analgesia, complications related to pain treatment, and morphine-related adverse events.
DISCUSSION
This will the first randomized controlled trial to compare ESPB with TPVB for analgesia after pectus excavatum repair. This trial aims to provide important clinical evidence to elaborate on the analgesic mechanism of ESPB in children.
TRIAL REGISTRATION
ClinicalTrials.gov NCT05034601 . This trial was prospectively registered.
背景
胸椎旁神经阻滞（TPVB）是一种广泛倡导的区域技术，可减轻接受择期漏斗胸修复术的儿童的术后疼痛。然而，该技术与一些不理想的不良事件相关。最近，竖脊肌平面阻滞（ESPB）已被引入作为胸外科中 TPVB 的实用替代方法。这种筋膜间区域麻醉技术通过在胸壁的肌肉层之间注射局部麻醉剂来阻断疼痛感觉。几项病例系列研究将其描述为一种有效的漏斗胸修复术后疼痛管理技术。因此，本试验旨在检验 ESPB 在漏斗胸修复术后疼痛控制方面不劣于 TPVB 的假设。
方法
这是一项前瞻性随机双盲非劣效性试验。总共 40 名 4 至 18 岁接受 Nuss 手术的患者将被随机分配接受 ESPB 或 TPVB 进行疼痛治疗。所有患者将接受静脉患者自控镇痛泵和对乙酰氨基酚的额外全身性多模式镇痛。主要结局是术后 24 小时的静息时疼痛强度。次要结局包括累积吗啡等效消耗量、术后疼痛评分、苏醒期躁动发生率、首次活动时间、首次解救镇痛时间、与疼痛治疗相关的并发症以及与吗啡相关的不良事件。
讨论
这将是第一项比较 ESPB 与 TPVB 在漏斗胸修复术后镇痛效果的随机对照试验。本试验旨在提供重要的临床证据，阐述 ESPB 在儿童中的镇痛机制。
试验注册
ClinicalTrials.gov NCT05034601。本试验是前瞻性注册的。
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