膈神经麻痹、呼吸功能和经肌间沟臂丛阻滞术后疼痛：接受关节镜肩关节手术患者使用 10ml 左旋布比卡因 0.25%与 20ml 剂量的比较：随机对照双盲 REDOLEV 研究方案。
Diaphragmatic paralysis, respiratory function, and postoperative pain after interscalene brachial plexus block with a reduced dose of 10 ml levobupivacaine 0.25% versus a 20 ml dose in patients undergoing arthroscopic shoulder surgery: study protocol for the randomized controlled double-blind REDOLEV study.
机构信息
Morphological Madrid Research Center Investigator, Department of Anesthesiology, Critical Care and Pain Management, Lozano Blesa University Clinical Hospital, Aragon Institute for Health Research, Avda. San Juan Bosco, 15 50009, Zaragoza, Spain.
Division of Regional Anesthesia, Department of Anesthesiology, Critical Care and Pain Management, Miguel Servet University Hospital, Zaragoza, Spain.
出版信息
Trials. 2021 Apr 19;22(1):287. doi: 10.1186/s13063-021-05216-6.
BACKGROUND
Arthroscopic shoulder surgery causes severe postoperative pain. An interscalene brachial plexus block provides adequate analgesia, but unintended spread of the local anesthetic administered may result in a phrenic nerve block, usually associated with a nonnegligible incidence of acute hemidiaphragmatic paralysis. The main purpose of this trial will be to analyze the incidence of hemidiaphragmatic paralysis ensuing after interscalene brachial plexus block in patients undergoing arthroscopic shoulder surgery administered a standard volume (20 ml) vs. a low volume (10 ml) of levobupivacaine 0.25%.
METHODS
This will be a prospective double-blind randomized controlled single-center two-arm comparative trial. Forty-eight patients will be included. The primary goal will be to ultrasonographically determine the incidence of hemidiaphragmatic paralysis by calculating the diaphragmatic thickness ratio in each group. The secondary goals will be to compare the two arms in terms of (1) decrease in forced vital capacity and (2) in forced expiratory volume at 1 s by spirometry; (3) decrease in diaphragmatic excursion by ultrasound; (4) 24-h total intravenous morphine consumption; (5) time to first opioid request of a patient-controlled analgesia pump; and (6) postoperative complications.
DISCUSSION
This trial will demonstrate that a low-volume interscalene brachial plexus block decreases hemidiaphragmatic paralysis following arthroscopic shoulder surgery according to spirometry and ultrasound measurements and does not provide inferior postoperative analgesia to the standard volume, as measured by opioid requirements.
TRIAL REGISTRATION
EudraCT and Spanish Trial Register (REec) registration number: 2019-003855-12 (registered on 7 January 2020). ClinicalTrials.gov identification number: NCT04385966 (retrospectively registered on 8 May 2020). Ethics Committee approval: EC19/093 (18 December 2019).
背景
关节镜肩关节手术会引起严重的术后疼痛。经肌间沟臂丛神经阻滞可提供充分的镇痛效果，但局麻药的意外扩散可能导致膈神经阻滞，通常与相当比例的急性膈肌麻痹相关。本试验的主要目的是分析在接受关节镜肩关节手术的患者中，给予标准容量（20ml）和低容量（10ml）左旋布比卡因 0.25%的经肌间沟臂丛神经阻滞时，膈神经阻滞的发生率。
方法
这将是一项前瞻性、双盲、随机、对照、单中心、双臂比较试验。将纳入 48 例患者。主要目标是通过计算每组的膈肌厚度比，经超声确定膈神经麻痹的发生率。次要目标是比较两组（1）肺活量的下降；（2）通过肺活量计测量的 1 秒用力呼气量；（3）超声测量的膈肌活动度下降；（4）24 小时静脉吗啡总消耗量；（5）患者自控镇痛泵首次请求阿片类药物的时间；（6）术后并发症。
讨论
本试验将证明，与标准容量相比，低容量经肌间沟臂丛神经阻滞可降低关节镜肩关节手术后的膈神经麻痹发生率，通过肺活量计和超声测量，且在阿片类药物需求方面，并不提供较差的术后镇痛效果。
试验注册
EudraCT 和西班牙试验注册（REec）注册号：2019-003855-12（2020 年 1 月 7 日注册）。ClinicalTrials.gov 识别号：NCT04385966（2020 年 5 月 8 日回顾性注册）。伦理委员会批准：EC19/093（2019 年 12 月 18 日）。
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