The Efficacy of Retroclavicular Versus Supraclavicular Brachial Plexus Block in Patients Undergoing Forearm and Hand Surgery: a Randomized Controlled Double-blinded Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Success rate (loss of sensation to pinprick in the forearm and hand)
研究概览
简要总结
Patients will be randomized to one of two groups:
- Supraclavicular group: supraclavicular brachial plexus block performed with the aid of ultrasound;
- Retroclavicular group: retroclavicular brachial plexus block performed with the aid of ultrasound.
详细描述
The study will be proposed to all patients undergoing formarm or hand surgery under brachial plexus block. Patients will be randomized to one of two groups The first group - supraclavicular group - will receive an ultrasound-guided brachial plexus block via the supraclavicular approach, by injection of 30 ml of a mixture of ropivacaine 0.5 % + mepivacaine 1 %. The second group - retroclavicular group - will receive an ultrasound-guided brachial plexus block via the retroclavicular approach, by injection of 30 ml of a mixture of ropivacaine 0.5 % + mepivacaine 1 %. Primary outcome is success rate at 30 minutes after the injection defined as loss of sensation to pinprick in the forearm and hand. Secondary outcomes are: needling time, time to first analgesic request, postoperative opioid consumption, pain scores at 12 and 24 hours postoperatively, block-related complications, and patient satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Adult patients who undergo forearm or hand surgery under brachial plexus block.
排除标准
- •History of allergic reaction to local anaesthetics
- •Peripheral neuropathy
- •Renal or hepatic insufficiency
- •Coagulation disorders
研究组 & 干预措施
supraclavicular
patients receive a supraclavicular block for forearm or hand surgery with 30 ml of a mixture of ropivacaine 0.5 % and mepivacaine 1 %
干预措施: supraclavicular block (Procedure)
retroclavicular block
patients receive a retroclavicular block for forearm or hand surgery with 30 ml of a mixture of ropivacaine 0.5 % and mepivacaine 1 %
干预措施: retroclavicular block (Procedure)
结局指标
主要结局
Success rate (loss of sensation to pinprick in the forearm and hand)
时间窗: 30 minutes after the injection
次要结局
- Patient satisfaction as assessed by numerical rating scale(24 hours)
- Time to first analgesic request(24 hours)
- Pain scores at 12 hours postoperatively(12 hours)
- Pain scores on postoperative day 1(24 hours)
- Needling time in seconds(15 min)
- Block-related complications(24 hours)
- Postoperative opioid consumption on postoperative day 1(24 hours)