Evaluation of Diaphragmatic Function After Interscalene Brachial Plexus Block With Liposomal Bupivacaine: A Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Identification the recovery time of diaphragmatic function after diaphragmatic paralysis caused by interscalene brachial plexus block
研究概览
简要总结
The study aims to evaluation the effects of Liposomal Bupivacaine on diaphragmatic function in patients undergoing upper limb surgery who receive Interscalene Brachial Plexus Block. A total of 120 eligible patients will be enrolled and divided into two groups: Group A will receive 20ml of 0.5% Hydrochloride Bupivacaine , while Group B will receive 10ml of 0.5% Hydrochloride Bupivacaine plus 10ml of Liposomal Bupivacaine. Assessments of diaphragmatic function, pulmonary function, and pain intensity will be performed before the block and at different time points after the block, with follow-up for adverse events. The study is scheduled to run from September 2025 to September 2026, with strict adherence to privacy protection and ethical guidelines.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
Patients and all outcome assessors responsible for diaphragmatic electromyography, pulmonary function testing, and pain score assessment were blinded to group allocation. Anesthesiologists performing the interscalene brachial plexus block and administering the study solutions were not blinded, due to the distinguishable appearance of the study formulations and the nature of the interventional procedure.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing upper limb surgery scheduled for interscalene brachial plexus block
- •Aged ≥ 18 years
- •American Society of Anesthesiologists (ASA) physical status I-III
排除标准
- •Known allergy or intolerance to amide local anesthetics
- •Nerve injury in the upper limb on the surgical side
- •Coagulopathy
- •Used opioid medications continuously for more than 3 weeks before surgery
- •History of pulmonary disease and a pulse oxygen saturation (SpO₂) < 95% (measured after 5 minutes of rest at room temperature without oxygen supplementation, using a transcutaneous pulse oximeter)
- •Refuse to participate or are deemed unsuitable for this trial by the researchers
- •Withdrawal Criteria:
- •Patients voluntarily withdrew their informed consent
- •Surgery was canceled or the anesthesia method was changed due to surgical factors before interscalene brachial plexus block
研究组 & 干预措施
Experimental Group: 0.5% Hydrochloride Bupivacaine (10ml) + Liposomal Bupivacaine (10ml) for ISBPB
ISBPB block group receiving combined administration of two drugs
干预措施: 0.5% Hydrochloride Bupivacaine 10ml (Drug)
0.5% Hydrochloride Bupivacaine (20ml) for ISBPB
ISBPB block control group receiving single administration of a single drug
干预措施: 0.5% Hydrochloride Bupivacaine 20ml (Drug)
Experimental Group: 0.5% Hydrochloride Bupivacaine (10ml) + Liposomal Bupivacaine (10ml) for ISBPB
ISBPB block group receiving combined administration of two drugs
干预措施: Liposomal Bupivacaine 10mL (Drug)
结局指标
主要结局
Identification the recovery time of diaphragmatic function after diaphragmatic paralysis caused by interscalene brachial plexus block
时间窗: From the initiation of interscalene brachial plexus block to the recovery of diaphragmatic function (within approximately 72 hours)
次要结局
- Identification the recovery time of pulmonary function after diaphragmatic paralysis(From the initiation of interscalene brachial plexus block to the recovery of pulmonary function (within approximately 72 hours))
- Identification the Incidence of hemidiaphragmatic paralysis at different time points(From the initiation of interscalene brachial plexus block to the recovery of diaphragmatic function (within approximately 72 hours))
- Identification the Proportion of pulmonary function recovery(Time Frame: From the initiation of interscalene brachial plexus block to the recovery of pulmonary function (within approximately 72 hours))
研究者
Diansan Su
Chair of the Department of Anesthesiology
Zhejiang University