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关节内基于标志点的神经阻滞与关节周围浸润用于全膝关节置换术后镇痛的随机非劣效性试验。

Intraoperative landmark-based genicular nerve block versus periarticular infiltration for postoperative analgesia in total knee arthroplasty: a randomized non-inferiority trial.

机构信息

Department of Anesthesiology, King Chulalongkorn Memorial Hospital, Bangkok, Thailand.

Department of Orthopaedics, Chulalongkorn University, Bangkok, Thailand.

出版信息

Reg Anesth Pain Med. 2024 Sep 2;49(9):669-676. doi: 10.1136/rapm-2023-104563.

DOI:10.1136/rapm-2023-104563
PMID:37898482
Abstract

INTRODUCTION

Genicular nerve blocks (GNBs) are an emerging technique that have been used as a part of multimodal analgesia for total knee arthroplasty. The efficacy of intraoperative landmark-based GNBs, a recently introduced technique, has been established. We hypothesized that it would provide non-inferior postoperative analgesia compared with periarticular infiltration (PAI) when combined with continuous adductor canal block.

METHODS

This study randomized 140 patients undergoing total knee arthroplasty to receive either intraoperative landmark-based GNB (GNB group) or PAI (PAI group), with 139 completing the study. The primary outcomes were the pain scores at rest and during movement at 12 hours postoperatively on an 11-point Numerical Rating Scale; the non-inferiority margin was 1. Pain scores at additional time points, intravenous morphine consumption, time to first rescue analgesia, functional performance and muscle strength tests, and sleep disturbance were also assessed.

RESULTS

At 12 hours postoperatively, the PAI and GNB groups had median resting pain scores of 0 (0-2) and 0 (0-2), respectively. The median difference was 0 (95% CI -0.4 to 0.4, p=1), with the 95% CI upper limit below the prespecified non-inferiority margin. The median pain score during movement was 1.5 (0-2.3) and 2 (1-3.1) in the PAI and GNB groups, respectively. The median difference was 0.9 (95% CI 0.3 to 1.6, p=0.004), failing to demonstrate non-inferiority. The GNB group had higher intravenous morphine consumption at 12 hours postoperatively and a shorter time to first rescue analgesia.

CONCLUSIONS

GNB compared with PAI provides non-inferior resting pain relief. Non-inferiority was not established for pain during movement.

TRIAL REGISTRATION NUMBER

TCTR20220406001 (www.thaiclinicaltrials.org).

摘要

简介

关节神经阻滞(GNB)是一种新兴技术,已被用作全膝关节置换术多模式镇痛的一部分。最近引入的术中基于标志的 GNB 技术的疗效已经确立。我们假设,与关节周围浸润(PAI)联合使用时,与连续收肌管阻滞联合使用时,它将提供非劣效的术后镇痛。

方法

这项研究将 140 名接受全膝关节置换术的患者随机分为接受术中基于标志的 GNB(GNB 组)或 PAI(PAI 组),其中 139 名完成了研究。主要结局是术后 12 小时静息和运动时的 11 分数字评分量表疼痛评分;非劣效性边界为 1。还评估了其他时间点的疼痛评分、静脉吗啡消耗量、首次解救性镇痛时间、功能表现和肌肉力量测试以及睡眠障碍。

结果

术后 12 小时,PAI 和 GNB 组静息疼痛评分中位数分别为 0(0-2)和 0(0-2)。中位数差异为 0(95%CI-0.4 至 0.4,p=1),95%CI 上限低于预设的非劣效性边界。PAI 和 GNB 组运动时疼痛评分中位数分别为 1.5(0-2.3)和 2(1-3.1)。中位数差异为 0.9(95%CI0.3 至 1.6,p=0.004),未能显示非劣效性。GNB 组术后 12 小时静脉吗啡消耗量较高,首次解救性镇痛时间较短。

结论

与 PAI 相比,GNB 可提供非劣效的静息疼痛缓解。在运动时的疼痛方面未确立非劣效性。

试验注册号

TCTR20220406001(www.thaiclinicaltrials.org)。

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