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临床试验/NCT02721290
NCT02721290Unknown不适用

Comparison of the Sensitive Cutaneous Block Distribution Following Femoral Nerve Block Using an Ultrasound Plus Neurostimulator Technique Versus an Approach Based on the Localization of the Femoral Artery.

Maisonneuve-Rosemont Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2016年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
80
试验地点
1
主要终点
Sensitive cutaneous block distribution area for the two techniques

研究概览

简要总结

In this study, we will be comparing two approaches to the femoral block. The first or classical approach and one that is the most popular in our institution is used by combining ultrasound guidance and neurostimulator to do the block. The second is performed with the ultrasound alone aiming at the inferolateral aspect of the femoral artery with the needle and injecting. The primary endpoint of the study is the sensitive cutaneous block distribution using both 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 (Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients scheduled for an elective surgery for which the anesthesiologist planned to do a single shot or continuous femoral nerve block.

排除标准

  • Any contraindication to the femoral nerve block (coagulopathy, infection, pre-existing neuropathy, local anesthetic allergy and refusal of local anesthesia).
  • Refusal to participate in the study
  • Inability to understand or communicate the effect of local anesthesia secondary to the femoral nerve bloc.

研究组 & 干预措施

Femoral nerve block using Ultrasound and neurostimulator

Active Comparator

Femoral block using the standard technique of ultrasound for femoral nerve identification and neurostimulator set at between 0.3-0.5 mA with quads muscle response for needle placement confirmation before injecting 20cc of Ropivacaine 0.5%.

干预措施: Femoral nerve block using Ultrasound and neurostimulator (Procedure)

Femoral nerve block using Ultrasound and neurostimulator

Active Comparator

Femoral block using the standard technique of ultrasound for femoral nerve identification and neurostimulator set at between 0.3-0.5 mA with quads muscle response for needle placement confirmation before injecting 20cc of Ropivacaine 0.5%.

干预措施: Ropivacaine 0.5% (Drug)

Femoral nerve block using femoral artery target

Experimental

Femoral block using the alternate technique of aiming for the inferolateral aspect of the femoral artery and injecting 20cc of Ropivacaine 0.5%.

干预措施: Femoral nerve block using Ultrasound (Procedure)

Femoral nerve block using femoral artery target

Experimental

Femoral block using the alternate technique of aiming for the inferolateral aspect of the femoral artery and injecting 20cc of Ropivacaine 0.5%.

干预措施: Ropivacaine 0.5% (Drug)

结局指标

主要结局

Sensitive cutaneous block distribution area for the two techniques

时间窗: 45 minutes

After performance of a femoral nerve block, ice will be applied on the skin to plot the anesthetized area at times 15, 30 and 45 mn. The sensation will be compared on a scale from 0 (no sensation) to 2 (no anesthesia) with the contralateral leg. An area in cm2 will be calculated for each of the patients and the two techniques will then be compared.

次要结局

  • Time of block completion(45 minutes)
  • Patient Satisfaction(45 minutes)
  • Ease of ultrasound visualization of the femoral artery(45 minutes)
  • Numbers of needle redirection(45 minutes)
  • Ease of ultrasound visualization of the femoral nerve(45 minutes)
  • Vascular puncture(45 minutes)
  • Paresthesia(45 minutes)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Issam TANOUBI

Associate professor

Maisonneuve-Rosemont Hospital

研究点 (1)

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