Ultrasound Guided Distal Sciatic Nerve Block - a Randomised Comparison With Nerve Stimulator Technique
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 250
- 主要终点
- Success Rate Without Supplementation
研究概览
简要总结
For distal sciatic nerve block this prospective, randomised comparison with ultrasound guided distal subepineural block tested the hypothesis, that intraepineural injection of local anesthetic using nerve stimulation technique is common and associated with high success rate.
详细描述
Classical methods for nerve localization (loss of resistance, cause of paresthesias, nerve stimulation technique)assumed that the target is a close approximation to the nerve, without epineural perforation. Intraneural injections were considered as evitable, with high risk for nerve damages.
Ultrasound guidance provided for the first time a real-time visualization of the spread of local anesthetic. Some recent studies proved, that an intraneural injection using nerve stimulator technique is common and not necessarily accompanied with nerve damages.
In the ultrasound group (group US) the investigators tested the hypothesis, that an intraneural injection of local anesthetic generate a high success rate and a short onset time without clinical apparent nerve damages.
In the nerve-stimulation group (group NS) the investigators tested the hypothesis, that an intraneural injection of local anesthetic is common, and in case of intraneural injection accompanied likewise with high success rate and shorter onset time.
For the sciatic division the investigators tested the hypothesis, that classical methods of nerve localization (nerve-stimulation technique, cause of paresthesias) are not able to avoid epineural perforation.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •elective surgery on the foot or ankle
- •tourniquet distal of the knee
- •adult patients, 18-75 years old
- •ASA-risk-groups I-III (American Society of Anesthesiologists)
- •informed consent
排除标准
- •severe coagulopathy
- •systemic inflammatory response
- •ASA-risk-groups > III (American Society of Anesthesiologists)
- •drug allergy: local anesthetics
- •pregnancy, lactation period
- •participation in other studies
- •addiction to drugs or alcohol
- •non-cooperative patients
研究组 & 干预措施
group US
Ultrasound guided block :
20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)
干预措施: midazolam (Drug)
group US
Ultrasound guided block :
20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)
干预措施: Prilocaine 1% (Drug)
group US
Ultrasound guided block :
20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)
干预措施: Ropivacaine 0.75% (Drug)
group US
Ultrasound guided block :
20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)
干预措施: ultrasound guidance (Device)
group NS
Nerve stimulation technique:
20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)
干预措施: midazolam (Drug)
group NS
Nerve stimulation technique:
20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)
干预措施: Prilocaine 1% (Drug)
group NS
Nerve stimulation technique:
20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)
干预措施: Ropivacaine 0.75% (Drug)
group NS
Nerve stimulation technique:
20ml Prilocaine 1% and 10ml Ropivacaine 0.75% (30ml Prilocaine 1% in outpatients)
干预措施: nerve stimulation technique (Device)
结局指标
主要结局
Success Rate Without Supplementation
时间窗: within 30-60 minutes after injection of the local anesthetic
After injection of local anesthetic a waiting period of 30-60 minutes was defined before completing a failed block. 1. success without supplementation = no additional analgetics or rescue blocks required (success rate without supplementation, outcome measure 1) 2. success with supplementation = analgetics or selective rescue blocks distal of the sciatic division required (success rate without supplementation and additionally all supplemented blocks, outcome measure 3) 3. failed block = change of anesthetic procedure (general, spinal) or rescue blocks proximal of the sciatic division
Time Until Readiness for Surgery (Minutes)
时间窗: within 60 minutes after injection of the local anesthetic
Success Rate With Supplementation
时间窗: later than 30-60 minutes after injection of the local anesthetic
After injection of local anesthetic a waiting period of 30-60 minutes was defined before completing a failed block. 1. success without supplementation = no additional analgetics or rescue blocks required (success rate without supplementation, outcome measure 1) 2. success with supplementation = analgetics or selective rescue blocks distal of the sciatic division required (success rate without supplementation and additionally all supplemented blocks, outcome measure 3) 3. failed block = change of anesthetic procedure (general, spinal) or rescue blocks proximal of the sciatic divisionSucces rate with supplementation
次要结局
未报告次要终点
研究者
Dr.med.Ronald Seidel
Dr.med.Ronald Seidel
Helios Research Center