Zhang Hongye, Wu Jinyu, Miao Yongsheng, Yuan Ying, Qu Zongyang, Zhang Yaonan, Hua Zhen
Department of Anesthesiology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, China.
Department of Anesthesiology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing, China; and Graduate School of Peking Union Medical College, Chinese Academy of Medical Sciences, Beijing, China.
Anesthesiology. 2025 Jan 1;142(1):155-165. doi: 10.1097/ALN.0000000000005159.
A brachial plexus block plays an important role in providing perioperative analgesia for shoulder surgery; however, the inherent risk of phrenic nerve block and resulting hemidiaphragmatic paralysis may limit its use in patients with compromised pulmonary function. This study aimed to evaluate the safety, efficacy, maximum tolerated volume, and optimal biologic volume of 0.5% ropivacaine used in a single-injection retroclavicular brachial plexus block for arthroscopic shoulder surgery.
In this seamless single-arm exploratory phase I/II trial, a novel Bayesian optimal interval design was used to guide volume escalation for determination of the maximum tolerated volume, followed by sequential volume expansion using Bayesian optimal phase 2 design to establish the optimal biologic volume. Fifty-four patients who underwent arthroscopic shoulder surgery received a single-injection retroclavicular brachial plexus block with 0.5% ropivacaine ranging from 15 to 40 ml. The primary outcomes were complete or partial hemidiaphragmatic paralysis in phase I, measured using ultrasound 30 min after block completion, and the block success in phase II, defined as achieving a total sensorimotor score 12 points or greater and the total sensory score 3 points or greater, measured through manual sensorimotor testing.
The maximum tolerated volume for the single-injection retroclavicular brachial plexus block was determined to be 35 ml of 0.5% ropivacaine, with a hemidiaphragmatic paralysis rate of 0.09 (95% credible interval, 0 to 0.29). The optimal biologic volume was found to be 25 ml, with a block success rate of 1.0 (95% credible interval, 0.95 to 1.0) and a negligible hemidiaphragmatic paralysis rate of 0.01 (95% credible interval, 0 to 0.06).
A single-injection retroclavicular brachial plexus block using 25 ml of 0.5% ropivacaine produced consistent block success with a minimal hemidiaphragmatic paralysis rate, suggesting the need for further studies to confirm this result in arthroscopic shoulder surgery.
臂丛神经阻滞在为肩部手术提供围手术期镇痛方面发挥着重要作用；然而，膈神经阻滞及由此导致的半侧膈肌麻痹的固有风险可能会限制其在肺功能受损患者中的应用。本研究旨在评估0.5%罗哌卡因用于关节镜下肩部手术的单次注射锁骨后臂丛神经阻滞的安全性、有效性、最大耐受容量和最佳生物学容量。
在这项无缝单臂探索性I/II期试验中，采用了一种新颖的贝叶斯最优区间设计来指导容量递增以确定最大耐受容量，随后使用贝叶斯最优2期设计进行序贯容量扩展以确定最佳生物学容量。54例行关节镜下肩部手术的患者接受了单次注射锁骨后臂丛神经阻滞，使用0.5%罗哌卡因，容量范围为15至40毫升。主要结局在I期为完全或部分半侧膈肌麻痹，在阻滞完成30分钟后使用超声测量；在II期为阻滞成功，定义为通过手动感觉运动测试获得的总感觉运动评分为12分或更高且总感觉评分为3分或更高。
单次注射锁骨后臂丛神经阻滞的最大耐受容量确定为35毫升0.5%罗哌卡因，半侧膈肌麻痹率为0.09（95%可信区间，0至0.29）。发现最佳生物学容量为25毫升，阻滞成功率为1.0（95%可信区间，0.95至1.0），半侧膈肌麻痹率可忽略不计，为0.01（95%可信区间，0至0.06）。
使用25毫升0.5%罗哌卡因进行单次注射锁骨后臂丛神经阻滞产生了一致的阻滞成功，且半侧膈肌麻痹率最低，提示需要进一步研究以在关节镜下肩部手术中证实这一结果。
