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竖脊肌平面阻滞与腹横肌平面阻滞在机器人腹股沟疝修补术中的比较:一项盲法、主动对照、随机试验。

Erector Spinae Plane Block versus Transversus Abdominis Plane Block for Robotic Inguinal Hernia Repair: A Blinded, Active-Controlled, Randomized Trial.

机构信息

Department of Surgery, Ospedale Regionale Bellinzona e Valli, Bellinzona, Switzerland; Department of Surgery, Spital Limmattal, Switzerland.

Department of Anesthesiology, Ospedale Regionale Bellinzona e Valli, Bellinzona, Switzerland.

出版信息

Pain Physician. 2024 Jan;27(1):27-34.

PMID:38285028
Abstract

BACKGROUND

Regional anesthetic nerve blocks are widely used in the treatment of pain after outpatient surgery to reduce opioid consumption. Erector spinae plane (ESP) block is a recently described technique with promising results in different scenarios.

OBJECTIVES

To compare ESP block efficacy with the commonly used transversus abdominis plane (TAP) block in patients undergoing robot-assisted inguinal hernia repair.

STUDY DESIGN

This was a randomized, blinded, active controlled, superiority trial with 2 parallel groups. The study was approved by the local ethics committee. Registration took place on; www.

CLINICALTRIALS

gov with the identifier NCT04750512.

SETTING

Adults undergoing robotic inguinal hernia repair were recruited between January 2021 and April 2022 in a single referral center of southern Switzerland.

METHODS

To ensure blinding, the study employed a "double dummy" design, where all patients underwent both TAP and ESP blocks, but only one block was therapeutically active. The therapeutic block contained ropivacaine 0.2%, while the other infiltration contained placebo. The therapeutic intervention varied between groups, with one group receiving the TAP block as the active treatment and the other group receiving the ESP block as the active treatment. Computer generated 1:1 randomization determined allocation, which took place immediately prior to the intervention. As a result, blinding included patients, anesthesia, and surgery providers, outcome assessors and statistical analysts. The main outcome measure was the highest reported pain score on a Visual Analog Scale (VAS) during the 6 hours following the end of general anesthesia. Secondary outcomes included pain scores at set intervals, analgesic consumption, and complications.

RESULTS

A total of 50 patients (25 per arm) were enrolled and included in the analysis. The study found no significant difference in the mean maximal VAS scores between the 2 groups (TAP block 22.2, ESP block 20, difference 2.2, 95% CI is -12.1 to 16.5). Secondary endpoints, including VAS pain scores at different time points, use of rescue analgesics, time to first walk, duration of stay, and frequency of adverse events, did not show any significant differences between the 2 groups. However, post-hoc analysis suggested a more stable effect over time for the ESP block compared to the TAP block.

LIMITATIONS

The main limitation is a higher variance in VAS scores than expected in the power calculations.

CONCLUSIONS

ESP block was not superior to TAP block in the treatment of post-operative pain among patients undergoing robotic inguinal hernia repair.

摘要

背景

区域麻醉神经阻滞在减少阿片类药物消耗方面被广泛用于门诊手术后的疼痛治疗。竖脊肌平面(ESP)阻滞是一种最近描述的技术,在不同情况下具有良好的效果。

目的

比较 ESP 阻滞在机器人辅助腹股沟疝修补术中与常用的腹横肌平面(TAP)阻滞的疗效。

研究设计

这是一项随机、盲法、主动对照、优效性试验,有 2 个平行组。该研究得到了当地伦理委员会的批准。注册网址为:www.clinicaltrials.gov,标识符为 NCT04750512。

研究地点

2021 年 1 月至 2022 年 4 月,瑞士南部一家转诊中心招募了接受机器人腹股沟疝修补术的成年人。

方法

为了确保盲法,该研究采用了“双盲剂”设计,所有患者均接受 TAP 和 ESP 阻滞,但只有一种阻滞具有治疗作用。治疗性阻滞含有 0.2%罗哌卡因,而另一种浸润含有安慰剂。治疗性干预在组间有所不同,一组接受 TAP 阻滞作为治疗性干预,另一组接受 ESP 阻滞作为治疗性干预。计算机生成的 1:1 随机化决定了分组,分组发生在干预之前。因此,包括患者、麻醉师和手术提供者、结果评估者和统计分析师在内的所有人员都被设盲。主要观察指标是全身麻醉结束后 6 小时内报告的最高视觉模拟评分(VAS)。次要结局指标包括设定时间间隔的疼痛评分、镇痛药物消耗和并发症。

结果

共有 50 名患者(每组 25 名)入组并纳入分析。研究发现两组之间平均最大 VAS 评分无显著差异(TAP 阻滞 22.2,ESP 阻滞 20,差异 2.2,95%CI 为-12.1 至 16.5)。次要终点,包括不同时间点的 VAS 疼痛评分、解救性镇痛药的使用、首次行走时间、住院时间和不良事件的频率,两组之间均无显著差异。然而,事后分析表明,ESP 阻滞的效果比 TAP 阻滞更稳定。

局限性

主要局限性是在计算效力时,VAS 评分的方差高于预期。

结论

在机器人辅助腹股沟疝修补术中,ESP 阻滞在治疗术后疼痛方面并不优于 TAP 阻滞。

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