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0.25%罗哌卡因预防90%肩关节镜手术患者半膈肌麻痹的最大有效剂量:一项超声引导下臂丛上干阻滞的偏倚硬币上下序贯分配试验

Maximum effective volume of 0.25% ropivacaine for preventing hemidiaphragmatic paralysis in 90% of patients undergoing shoulder arthroscopy: a biased coin up-and-down sequential allocation trial for ultrasound-guided superior trunk block.

作者信息

Wang Kai, Zhu Hongwei, Zhou Yangyang, Gui Shukai, Li Yonghua

机构信息

Department of Anesthesiology, Second Affiliated Hospital, Changzheng Hospital, Naval Medical University, Shanghai, China.

出版信息

BMC Anesthesiol. 2025 Jul 30;25(1):381. doi: 10.1186/s12871-025-03273-x.

Abstract

BACKGROUND

Compared to interscalene block (ISB), the superior trunk block (STB) lowers the incidence of hemidiaphragmatic paralysis (HDP) without compromising analgesic efficacy, making it a valuable alternative. However, the lack of consensus on the optimal local anesthetic (LA) dose for STB limits its standardized clinical application. This study employed a dose-finding protocol to determine the maximum effective volume of 0.25% ropivacaine required to prevent HDP in 90% of patients (MEV90) undergoing shoulder arthroscopy with ultrasound-guided STB.

METHODS

A biased coin design was used for volume assignment. All patients except the first one received a LA volume determined by the response observed in the immediately preceding participant. In case of "failure" (defined as the presence of HDP after STB), the subsequent patient received a lower volume (2 mL less than the previous dose). In case of "success" (absence of HDP), subsequent patients were randomly allocated to received either: (1) an increased volume (2 ml higher than the previous dose) with an 11% probability, or (2) the same volume with an 89% probability.

RESULTS

The study cohort comprised 52 patients indicated for shoulder arthroscopy finally. Using isotonic regression with bootstrapped confidence intervals (CIs), the MEV90 of 0.25% ropivacaine for ultrasound-guided STB was estimated at 7.6 mL (95% CI: 6.5-8.5 mL).

CONCLUSIONS

The MEV90 of 0.25% ropivacaine for ultrasound-guided superior trunk block to prevent hemidiaphragmatic paralysis was 7.6 mL.

TRIAL REGISTRATION

Chinese Clinical Trial Registry (ChiCTR2200059042); first registered 23/04/2022.

摘要

背景

与肌间沟阻滞(ISB)相比,臂丛上干阻滞(STB)在不影响镇痛效果的情况下降低了半膈肌麻痹(HDP)的发生率,使其成为一种有价值的替代方法。然而,对于STB的最佳局部麻醉药(LA)剂量缺乏共识,限制了其标准化的临床应用。本研究采用剂量探索方案,以确定在超声引导下进行肩关节镜检查的患者中,90%的患者预防HDP所需的0.25%罗哌卡因的最大有效体积(MEV90)。

方法

采用偏倚硬币设计进行体积分配。除第一名患者外,所有患者接受的LA体积由前一名参与者的反应决定。若出现“失败”(定义为STB后出现HDP),则随后的患者接受较低体积(比前一剂量少2 mL)。若出现“成功”(无HDP),则随后的患者被随机分配接受以下两种情况之一:(1)以11%的概率接受增加的体积(比前一剂量高2 mL),或(2)以89%的概率接受相同体积。

结果

该研究队列最终包括52例拟行肩关节镜检查的患者。使用带有自抽样置信区间(CIs)的等渗回归,估计超声引导下STB的0.25%罗哌卡因的MEV90为7.6 mL(95% CI:6.5 - 8.5 mL)。

结论

超声引导下臂丛上干阻滞预防半膈肌麻痹的0.25%罗哌卡因的MEV90为7.6 mL。

试验注册

中国临床试验注册中心(ChiCTR2200059042);首次注册于2022年4月23日。

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