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临床试验/NCT00956709
NCT00956709终止4 期

Regional Anesthesia for Major Surgery of the Foot. Levobupivacaïne Ropivacaine 0.5% Versus 0.5% in the Sciatic Block Through médiofémorale

Nantes University Hospital1 个研究点 分布在 1 个国家目标入组 35 人开始时间: 2008年12月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
入组人数
35
试验地点
1
主要终点
Compare the Onset of Action of Ropivacaine 0.5% and levobupivacaïne 0.5 % for Sciatic Nerve Block Guided in Major Surgery of the Foot

研究概览

简要总结

Ropivacaine 0.5% and 0.5% in levobupivacaïne are used in regional anesthesia for major surgery of the foot. The literature does not highlight a significant difference in terms of onset of action between these two molecules to block the sciatic nerve [4]. Our hypothesis is that this lack of difference is due to the use of a neurostimulator for locating the injection site (indiscriminate nature of the anatomical approach to the sciatic nerve). Indeed, the sensitivity of neurostimulation is low compared with ultrasound [58] and ultrasound, for accurate visualization of the deposit of the local anesthetic around the nerve to improve the quality of the block and reduce the onset of action of local anesthetic [46, 47].

The investigators propose to make a comparative trial between levobupivacaïne 0.5% ropivacaine and 0.5% under the control of the ultrasound as part of a sciatic nerve block. The use of ultrasound will reduce the variability of results because the changes would be linked exclusively to the local anesthetic. The investigators test the hypothesis that levobupivacaïne gives better results in terms of onset of action than ropivacaine.

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 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with unilateral major surgery of the foot: hallux valgus (not ambulatory), claw toes, fusion-Astragalo calcaneum, complex syntheses of tarsus-aged over 18 years .
  • Male and female
  • ASA 1 or 2
  • Insured Social
  • Informed Consent

排除标准

  • Intoxication-alcoholic chronic
  • Allergy to local anesthetics
  • Hemostasis disorders
  • Hepatic failure
  • Chronic pain syndrome

研究组 & 干预措施

Ropivacaïne 0,5%

Active Comparator

干预措施: ropivacaïne 0,5 % (Drug)

Levobupivacaïne 0,5 %

Active Comparator

干预措施: levobupivacaïne 0,5 % (Drug)

结局指标

主要结局

Compare the Onset of Action of Ropivacaine 0.5% and levobupivacaïne 0.5 % for Sciatic Nerve Block Guided in Major Surgery of the Foot

时间窗: 72 hours

次要结局

  • Evaluate the Relative Position of the Tibial and Contigent Fibulaire Common in the Sciatic Nerve.(72 hours)
  • Duration of Motor Sciatic Block (h)(72 hours)
  • Duration of Sensory Sciatic Block (h)(72 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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