Comparison of Ultrasound-Guided Single Injection Infraclavicular Block or Ultrasound-Guided Double Injection Axillary Block : A Non-inferiority Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 224
- 试验地点
- 4
- 主要终点
- Number of Patients With Complete Sensory Block
研究概览
简要总结
The purpose of this study is to compare the rate of complete sensory block at 30 minutes following ultrasound-guided single injection infraclavicular block and ultrasound-guided double injection axillary block. The investigators research hypothesis is that both blocks will show comparable rates of complete sensory block at 30 minutes.
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
- Single (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
- •18 years or older
- •American Society of Anesthesiologists Class 1 to 3
- •Undergoing a surgery at the elbow, forearm, wrist or hand under regional anesthesia
排除标准
- •Age less than 18 years
- •Body mass index more than 40 kg/m2
- •Weight less than 45 kg
- •Patient refusal
- •Contraindication to regional anesthesia (coagulopathy, local infection at the puncture site, systemic infection)
- •Previous neurological deficit in the operated arm
- •Severe renal or hepatic failure
- •Prior surgery in the axillary or infraclavicular area
- •Pregnancy or breast-feeding
研究组 & 干预措施
Ultrasound-guided axillary block
Ultrasound-guided double injection axillary block
干预措施: Ultrasound-guided axillary block (Procedure)
Ultrasound-guided infraclavicular block
Ultrasound-guided single injection infraclavicular block
干预措施: Ultrasound-guided infraclavicular block (Procedure)
结局指标
主要结局
Number of Patients With Complete Sensory Block
时间窗: 30 minutes after block completion
Complete sensory block is defined by anesthesia to cold sensation in the ulnar, radial, median and musculocutaneous nerves territories.
次要结局
- Procedure-related Pain on a Visual Analog Pain Scale(After the nerve block procedure ended, up to 5 minutes.)
- Number of Patients With Postoperative Adverse Events Related to Nerve Block(1 month after surgery)
- Number of Patients With Complete Motor Blocks(30 minutes after block completion)
- Time to Complete Sensory Block.(5, 10, 15, 20, 25 and 30 minutes after block completion)
- Time to Complete Motor Block(5, 10, 15, 20, 25 and 30 minutes after block completion)
- Surgical Block Success Rate(End of surgery)
- Performance Time of the Nerve Block(During the performance of the block)
- Duration of Surgery(The end of surgery)
- Tourniquet Use(The end of surgery)
- Duration of Tourniquet(The end of surgery)
研究者
Ariane Boivin
MD
CHU de Quebec-Universite Laval