Costoclavicular vs Paracoracoid Approach to Infraclavicular Brachial Plexus Block: a Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Block onset time
研究概览
简要总结
Patients for upper limb surgeries who are candidates for infraclavicular block will be screened. Two techniques of infraclavicular block will be compared. Measured outcomes are performance times, block onset times, patient satisfaction, quality of block, and requirement for supplementary analgesia.
详细描述
Infraclavicular brachial plexus block under ultrasound guidance is used for surgeries on the upper limb. Traditionally, the block is performed at the lateral infraclavicular fossa where the cords are variable in position relative to the axillary artery. A recently introduced technique is the costoclavicular approach where the cords are viewed as relatively more superficial and clustered together compared to the traditional technique. Those meeting the inclusion criteria and will consent to participate in the study will be randomized to have either an infraclavicular block in the paracoracoid approach (Group 1) or an infraclavicular block in the costoclavicular approach (Group 2). All groups will have the same injectable volume (35 mls) and local anesthetic concentration (ropivacaine 0.5%). There will be 35 study patients for each group for a total of 70 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Ambulatory elective surgery of the upper limb
- •ASA (American Society of Anesthesiologists physical status classification system) 1-4
- •Suitable for procedure to be carried out under infraclavicular block
排除标准
- •Inability to give informed consent, Allergy to local anesthetics, morphine or fentanyl
- •Ongoing major medical or psychiatric problems
- •Narcotic abuse
- •Peripheral neuropathy or major neurological problems
- •Scarring in area of blockade
- •Inability to co-operate with post-operative evaluation
- •Major coagulopathy
- •Pregnancy and breast-feeding
- •Women of childbearing age who are not taking adequate contraceptive precautions
研究组 & 干预措施
Costoclavicular
Ultrasound-guided infraclavicular block using Ropivacaine 0.5% 35 mL using the costoclavicular approach
干预措施: Ropivacaine (Drug)
Costoclavicular
Ultrasound-guided infraclavicular block using Ropivacaine 0.5% 35 mL using the costoclavicular approach
干预措施: Ultrasound (Device)
Paracoracoid
Ultrasound-guided infraclavicular block using Ropivacaine 0.5% 35 mL using the paracoracoid or standard approach
干预措施: Ropivacaine (Drug)
Paracoracoid
Ultrasound-guided infraclavicular block using Ropivacaine 0.5% 35 mL using the paracoracoid or standard approach
干预措施: Ultrasound (Device)
结局指标
主要结局
Block onset time
时间窗: 1 hour
From the time needle is removed from the patient's skin up to the time when block is considered adequate for surgery
次要结局
- Procedure duration(1 hour)
- Quality of block(1 hour)
- Patient satisfaction(1 day)
- Requirement for supplemental analgesia or anesthesia(1 day)
研究者
Shalini Dhir
Dr.
Lawson Health Research Institute