直视下经弓状韧带低位胸段椎旁阻滞对活体供肾移植腹腔镜供肾切除术后恢复质量的影响:一项前瞻性、盲法、随机对照临床试验的研究方案

Effect of Low Thoracic Paravertebral Block via the Arcuate Ligament Under Direct Visualization on the Quality of Postoperative Recovery After Laparoscopic Donor Nephrectomy for Living-Donor Kidney Transplantation: Study Protocol for a Prospective, Blinded, Randomized Controlled Clinical Trial.

作者信息

Cui Lingli, Zhu Yichen, Liu Shen, Zhang Liang, Zhu Qian, Wang Yun, Ma Danxu

机构信息

Department of Anesthesiology, Beijing Friendship Hospital, Capital Medical University, Beijing, 100050, People's Republic of China.

Department of Urology, Beijing Friendship hospital, Capital Medical University, Beijing, 100050, People's Republic of China.

出版信息

J Pain Res. 2025 May 13;18:2409-2416. doi: 10.2147/JPR.S516772. eCollection 2025.

Abstract

INTRODUCTION

Laparoscopic donor nephrectomy (LDN) is the standard procedure for donor nephrectomy for living kidney transplantation. Compared with traditional open surgery, the laparoscopic techniques have been developed to significantly reduce postoperative pain and accelerate postoperative recovery; however, most donors still experience more than moderate pain after surgery. Ensuring maximum perioperative safety and postoperative pain control for donors remains a top priority for LDN. Our group reported a novel blockade technique that allows local anesthetic to be injected directly to reach the low thoracic paravertebral space under direct laparoscopic observation via the arcuate ligament to achieve somatic and visceral pain analgesia; this technique has been successfully applied to patients undergoing retroperitoneal laparoscopic nephrectomy. We hypothesized that compared with the transversus abdominis plane (TAP) block, low thoracic paravertebral block (TPVB) via the arcuate ligament under direct vision would reduce the consumption of postoperative opioids and improve the quality of postoperative recovery of donors after LDN.

METHODS/ANALYSIS: This study is a prospective blind, randomized, controlled clinical trial with a concealed allocation of donors scheduled to undergo elective LDN 1:1 to receive either a low TPVB via the arcuate ligament under direct vision or a TAP block. This study will recruit a total of 82 living kidney donors. The primary outcome is the 15-item recovery quality scale (QoR-15) score at 24 hours after surgery.

ETHICS AND DISSEMINATION

This trial was approved by the Ethics Committee of Beijing Friendship Hospital, Capital Medical University. This trial study protocol was approved on 30 November 2024. The trial started recruiting patients after being registered on the Chinese Clinical Trial Registry.

TRIAL REGISTRATION NUMBER

ChiCTR2400094612.

摘要

引言

腹腔镜供肾切除术(LDN)是活体肾移植供肾切除术的标准术式。与传统开放手术相比,腹腔镜技术的发展显著减轻了术后疼痛并加速了术后恢复;然而,大多数供者术后仍经历中度以上疼痛。确保供者围手术期的最大安全性和术后疼痛控制仍是LDN的首要任务。我们团队报道了一种新型阻滞技术,该技术可在腹腔镜直视下经弓状韧带将局麻药直接注入到胸段低位椎旁间隙,以实现躯体和内脏痛觉镇痛;该技术已成功应用于接受腹膜后腹腔镜肾切除术的患者。我们推测,与腹横肌平面(TAP)阻滞相比,直视下经弓状韧带的胸段低位椎旁阻滞(TPVB)可减少LDN术后供者阿片类药物的用量,并改善术后恢复质量。

方法/分析:本研究是一项前瞻性、盲法、随机对照临床试验,将计划接受择期LDN的供者按1:1进行隐蔽分组,分别接受直视下经弓状韧带的低位TPVB或TAP阻滞。本研究共招募82名活体肾供者。主要结局指标为术后24小时的15项恢复质量量表(QoR-15)评分。

伦理与传播

本试验已获得首都医科大学附属北京友谊医院伦理委员会批准。本试验研究方案于2024年11月30日获批。该试验在中国临床试验注册中心注册后开始招募患者。

试验注册号

ChiCTR2400094612。

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