腹腔镜根治性肾切除术术后镇痛的锯下肌前平面阻滞vs胸椎旁阻滞:一项随机对照、双盲、非劣效性临床试验方案

IF 2.5 3区 医学 Q2 CLINICAL NEUROLOGY
Journal of Pain Research Pub Date : 2025-03-25 eCollection Date: 2025-01-01 DOI:10.2147/JPR.S506226
Jianghuai Lin, Huanghui Wu, Zhibin Wen, Yangyi Li, Changcheng Jiang, Binghong Lin, Yu Gu
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引用次数: 0

摘要

胸椎旁神经阻滞(TPVB)是一种广泛应用于腹部手术的区域麻醉技术。尽管锯下肌前平面阻滞(SSAPB)已显示出在上腹部手术中提供镇痛的有效性,但目前尚不清楚SSAPB是否能在腹膜后腹腔镜肾切除术中提供与TPVB相当的镇痛效果。方法与分析:本研究是一项前瞻性、随机对照、双盲、单中心、非劣效性试验,共纳入106例经腹膜后腹腔镜肾切除术患者。参与者将按1:1的比例随机分配到SSAPB组或TPVB组。超声引导的SSAPB和TPVB均涉及在麻醉诱导前以0.4 mL/kg的剂量给予0.375%的罗哌卡因。随后,将在手术中使用阿片类药物麻醉。每位患者将接受标准化的患者控制静脉镇痛(PCIA),无需背景输液。主要结局指标将是术后24小时阿片类药物的使用情况。次要结局包括术后48小时内不同预定时间点的疼痛视觉模拟量表(VAS)评分、术中和术后镇痛药消耗、首次给药时间、围手术期心肺不良事件发生率、阻滞特征评估、恢复质量、下床时间和开始口服饮食时间、以及在术后麻醉护理病房(PACU)和医院的住院时间。此外,炎症标志物的水平,包括白细胞介素-6 (IL-6)和c反应蛋白(CRP),将在预定义的时间点进行评估。讨论:本方案概述了第一项前瞻性、随机对照、双盲、非劣效性临床试验,比较了sssapb与TPVB在不使用阿片类药物麻醉下行腹膜后腹腔镜肾切除术患者围手术期镇痛疗效和安全性。该研究的目的是产生初步的见解,以优化区域麻醉策略围手术期疼痛管理的手术队列。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Subserratus Anterior Plane Block vs Thoracic Paravertebral Block for Postoperative Analgesia in Laparoscopic Radical Nephrectomy: Protocol for a Randomized Controlled, Double-Blind, Non-Inferiority Clinical Trial.

Introduction: Thoracic paravertebral nerve block (TPVB) is a widely used regional anesthesia technique employed in opioid-sparing anesthesia for abdominal surgery. Although the subserratus anterior plane block (SSAPB) has shown effectiveness in providing analgesia in upper abdominal surgery, it remains unclear whether the SSAPB offers comparable analgesic effects to the TPVB for retroperitoneal laparoscopic nephrectomy.

Methods and analysis: This study is designed as a prospective, randomized controlled, double-blind, single-center, non-inferiority trial involving a total of 106 patients undergoing retroperitoneal laparoscopic nephrectomy. Participants will be randomly assigned to either the SSAPB group or the TPVB group in a 1:1 ratio. Both ultrasound-guided SSAPB and TPVB will involve the administration of 0.375% ropivacaine at a dose of 0.4 mL/kg prior to anesthesia induction. Subsequently, opioid-sparing anesthesia will be utilized during surgery. Each patient will receive standardized patient-controlled intravenous analgesia (PCIA) without a background infusion. The primary outcome measure will be the 24-hour postoperative consumption of rescue opioids. Secondary outcomes will include pain visual analogue scale (VAS) scores at various predefined time points within 48 hours post-surgery, analgesic consumption during and after surgery, time to first administration of rescue analgesics, incidence of perioperative cardiopulmonary adverse events, assessment of block characteristics, quality of recovery, time to ambulation and initiation of an oral diet, and length of stay in both the postoperative anesthesia care unit (PACU) and the hospital. Additionally, levels of inflammatory markers, including interleukin-6 (IL-6) and C-reactive protein (CRP), will be assessed at predefined time points.

Discussion: This protocol outlines the first prospective, randomized controlled, double-blinded, non-inferiority clinical trial comparing perioperative analgesic efficacy and safety of SSAPB versus TPVB in patients undergoing retroperitoneal laparoscopic nephrectomy under opioid-sparing anesthesia. The study is designed to generate preliminary insights into optimizing regional anesthesia strategies for perioperative pain management in this surgical cohort.

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来源期刊
Journal of Pain Research
Journal of Pain Research CLINICAL NEUROLOGY-
CiteScore
4.50
自引率
3.70%
发文量
411
审稿时长
16 weeks
期刊介绍: Journal of Pain Research is an international, peer-reviewed, open access journal that welcomes laboratory and clinical findings in the fields of pain research and the prevention and management of pain. Original research, reviews, symposium reports, hypothesis formation and commentaries are all considered for publication. Additionally, the journal now welcomes the submission of pain-policy-related editorials and commentaries, particularly in regard to ethical, regulatory, forensic, and other legal issues in pain medicine, and to the education of pain practitioners and researchers.
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