Single-shot Versus Slow Infusion Interscalene Block and Its Impact on Diaphragmatic Function in Patients Undergoing Shoulder Surgery, a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Complete phrenic nerve block defined as > 75% reduction in diaphragmatic excursion
研究概览
简要总结
Interscalene brachial plexus block is a commonly chosen anesthetic technique for shoulder and proximal arm surgery yet it carry several risks including phrenic nerve block.
Researchers assumed that slow administration of local anesthetic would reduce incidence of phrenic nerve block
详细描述
patients will be randomly allocated into one of 2 groups ( single shot group) and slow administration group . single shot will receive a 10 ml bolus of 0.5% bupivacaine the other group will receive 10 ml 0.5 % bupivacaine over 10 minutes (at a rate of 1ml/minute) using syringe pump An experienced operator who will be blinded to method of administration will conducted diaphragmatic excursion of ipsilateral hemidiaphragm using curved probe at baseline and at 10 minutes interval for 30 minutes Complete phrenic will be defined as 75% or more reduction in DE, while partial failure as 25%-50% reduction in DE
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA I or II undergoing shoulder surgery under GA
排除标准
- 未提供
研究组 & 干预措施
Slow administration group
They will receive 10 ml of 0.5% bupivacaine over 10 minutes
干预措施: Diaphragmatic excursion evaluation (Device)
Single shot
They will receive a 10 ml of 0.5 % bupivacaine as a single shot
干预措施: Diaphragmatic excursion evaluation (Device)
结局指标
主要结局
Complete phrenic nerve block defined as > 75% reduction in diaphragmatic excursion
时间窗: baseline and 30 minutes after the block
defined as \> 75% reduction in diaphragmatic excursion
次要结局
- partial phrenic block(baseline and 30 minutes after the block)
研究者
Mina Adolf Helmy
Lecturer of anesthesia, Cairo university
Cairo University