Onset Time of Brachial Plexus Anesthesia With the Axillary or Infraclavicular Approach Under Real-Time Ultrasound Guidance: a Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Onset time of brachial plexus sensory block
研究概览
简要总结
This study aims to detect differences in onset time of brachial plexus (i.e., arm) anesthesia using two different nerve block techniques.
Using ultrasound guidance, axillary (i.e., at the armpit) and infraclavicular (i.e., below the collarbone) blocks will be performed to patients undergoing upper limb surgery.
The investigators will analyze how long it takes for anesthesia to be adequate for pain-free surgery, thus determine the optimal technique for this kind of surgery.
详细描述
Real-time ultrasound guidance has substantially reduced the risk of pneumothorax and/or vascular puncture during infraclavicular brachial plexus blocks. The role of this technique has thus been expanded to overlap those procedures for which an axillary nerve block would be commonly considered as first choice.
A reference block for upper limb surgery thanks to its safety profile and clinical efficacy, the axillary approach may be more painful or unpleasant for some patients.
The investigators aim to determine possible differences in onset time and patient acceptance between the two techniques.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA Physical Status Class <4
- •Scheduled upper extremity orthopedic surgery
排除标准
- •Psychiatric or cognitive disorder
- •Allergy to study drugs
- •Contraindication to nerve block at the assigned site
研究组 & 干预措施
Infraclavicular
This group will receive an ultrasound-guided infraclavicular brachial plexus block.
干预措施: Midazolam (Drug)
Infraclavicular
This group will receive an ultrasound-guided infraclavicular brachial plexus block.
干预措施: Ropivacaine (Drug)
Infraclavicular
This group will receive an ultrasound-guided infraclavicular brachial plexus block.
干预措施: Fentanyl (Drug)
Infraclavicular
This group will receive an ultrasound-guided infraclavicular brachial plexus block.
干预措施: General anesthesia (Procedure)
Infraclavicular
This group will receive an ultrasound-guided infraclavicular brachial plexus block.
干预措施: Infraclavicular brachial plexus block (Procedure)
Axillary
This group will receive an ultrasound-guided axillary brachial plexus block.
干预措施: Midazolam (Drug)
Axillary
This group will receive an ultrasound-guided axillary brachial plexus block.
干预措施: Ropivacaine (Drug)
Axillary
This group will receive an ultrasound-guided axillary brachial plexus block.
干预措施: Fentanyl (Drug)
Axillary
This group will receive an ultrasound-guided axillary brachial plexus block.
干预措施: General anesthesia (Procedure)
Axillary
This group will receive an ultrasound-guided axillary brachial plexus block.
干预措施: Axillary brachial plexus nerve block (Procedure)
结局指标
主要结局
Onset time of brachial plexus sensory block
时间窗: q5min up to 30 min after the block
次要结局
- Rescue analgesic requirements during surgery(During surgery)
- Anesthesia-related procedural pain (0-10 numerical rating scale)(End of block placement)
- Onset of brachial plexus motor block(q5min up to 30 min after the block)
- Patient satisfaction (3-point scale)(End of surgery)