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局部麻醉下有无正中神经远端阻滞的腕管松解术:双盲随机临床试验

Carpal tunnel release under local anesthesia with or without distal median nerve block: Double-blind randomized clinical trial.

作者信息

Heikkinen Noora, Nietosvaara Yrjänä, Reito Aleksi, Sirola Joonas, Hytönen Mikael, Savolainen Aukusti, Räisänen Mikko P

机构信息

University of Eastern Finland, (BM) Yliopistonranta 1, Kuopio 70211, Finland.

University of Eastern Finland, Kuopio, Finland.

出版信息

Scand J Surg. 2025 Mar;114(1):13-21. doi: 10.1177/14574969241277028. Epub 2024 Sep 19.

Abstract

BACKGROUND

Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy of the upper extremity, and its surgical treatment is carpal tunnel release (CTR). It is mostly performed in local anesthesia. There are no clinical randomized controlled trials (RCTs) comparing local infiltration anesthesia with or without a distal median nerve block in CTR. The aim of the PERSONNEL trial (carPal tunnEl ReleaSe lOcal iNfiltratioN mEdian bLockade) is to assess whether a distal median nerve block reduces pain during and after the procedure in addition to local anesthesia.

METHODS

This is a single-center randomized clinical superiority trial comparing local anesthesia alone and local anesthesia with a distal median nerve block for CTR in patients with CTS. Adult patients will be randomized in one university hospital in Finland, and the intended sample size is 118. The primary outcome is the mean pain level after the procedure during 72 h using a visual analogue scale (VAS). The secondary outcomes include expected pain; pain during the injection of the anesthetic solution caused by pressure, burning, needle sting, and total pain; worst pain during the surgery; duration of anesthesia; number of experienced needle stings; Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ); pain killer consumption;, patient satisfaction using Net Promoter Score (NPS); and complications.

DISCUSSION

Patient satisfaction is a crucial factor in modern healthcare. A distal median nerve block may reduce pain during and after CTR, potentially increasing patient satisfaction with the given treatment. It can also be hypothesized that better postoperative pain control may prevent complications, for example, complex regional pain syndrome. However, we lack adequate evidence to justify the use of distal median nerve block, which can itself predispose patients to complications, for example, median nerve injury. Therefore, there is a need for adequate RCTs to assess its efficacy. The results of this study can be used to optimize anesthesia for carpal tunnel surgery, improve patient satisfaction, and possibly prevent complications.

REGISTRATION

ClinicalTrials.gov NCT05372393.

摘要

背景

腕管综合征(CTS)是上肢最常见的卡压性神经病变,其外科治疗方法是腕管松解术(CTR)。该手术大多在局部麻醉下进行。目前尚无比较CTR中局部浸润麻醉加或不加正中神经远端阻滞的临床随机对照试验(RCT)。PERSONNEL试验(腕管松解局部浸润正中神经阻滞)的目的是评估正中神经远端阻滞除局部麻醉外是否能减轻手术期间及术后的疼痛。

方法

这是一项单中心随机临床优效性试验,比较单纯局部麻醉与局部麻醉加正中神经远端阻滞用于CTS患者CTR的效果。成年患者将在芬兰的一家大学医院进行随机分组,预期样本量为118例。主要结局是术后72小时内使用视觉模拟量表(VAS)评估的平均疼痛水平。次要结局包括预期疼痛;注射麻醉溶液时因压力、烧灼感、针刺感引起的疼痛及总疼痛;手术期间的最严重疼痛;麻醉持续时间;经历的针刺次数;波士顿腕管综合征问卷(BCTSQ);止痛药消耗量;使用净推荐值(NPS)评估的患者满意度;以及并发症。

讨论

患者满意度是现代医疗保健中的一个关键因素。正中神经远端阻滞可能减轻CTR期间及术后的疼痛,有可能提高患者对既定治疗的满意度。还可以推测,更好的术后疼痛控制可能预防并发症,例如复杂性区域疼痛综合征。然而,我们缺乏充分的证据来证明使用正中神经远端阻滞的合理性,因为其本身可能使患者易发生并发症,例如正中神经损伤。因此,需要进行充分的RCT来评估其疗效。本研究结果可用于优化腕管手术的麻醉方法,提高患者满意度,并可能预防并发症。

注册信息

ClinicalTrials.gov NCT05372393

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