The Minimum Effective Volume of Ropivacaine in Ultrasound-guided Supraclavicular Block
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- The Minimum Effective Volume of Ropivacaine in Ultrasound-guided Supraclavicular Block
研究概览
简要总结
The aim of this study is to determine the minimum effective volume of local anesthetic (ropivacaine 0.275% and 0.325%) required to produce an effective double-injection USG-SCB for surgical anesthesia in 90% of patients (MEV90) in young group (18-40 years) and in middle aged group (40-65 years) of patients scheduled for elective surgery of one upper limb distal to the shoulder.
详细描述
The study is based on biased coin design, and the volume of LA for the next patient is determined by the result of the last one. In the case of block failure, the volume will be increased by 2ml. Conversely, block success will result in either a reduction in volume by 2ml (probability 11%) or no change in volume (probability 89%). A blinded assistant will assess sensory and motor blockade in each nerve territory ( the median, radial, ulnar and musculocutaneous nerves) at 10-min intervals up to 30 min after completion of the block. Finally, MEV90 is calculated by isotonic regression.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18 and 65 years
- •body mass index between 18 and 35kg/m2
排除标准
- •inability to consent to the study
- •allergy to local anesthetics
- •preexisting neuropathy or coagulopathy
- •prior surgery in the supraclavicular region
研究组 & 干预措施
middle aged group
brachial plexus block with ropivacaine 0.275%, MEV90 for USG-SCB
干预措施: Ropivacaine (Drug)
young group
brachial plexus block with ropivacaine 0.325%, MEV90 for USG-SCB
干预措施: Ropivacaine (Drug)
结局指标
主要结局
The Minimum Effective Volume of Ropivacaine in Ultrasound-guided Supraclavicular Block
时间窗: up to 6 months
The Minimum Effective Volume (MEV) of Ropivacaine in Ultrasound-guided Supraclavicular Block is based on 55 measurements in 55 patients (secondary outcome measure: block success). MEV is determined by biased coin design method when all patients have been tested in the study.
次要结局
未报告次要终点
研究者
Fang Gang
Dr.
Huazhong University of Science and Technology