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临床试验/NCT00567450
NCT00567450已完成4 期

Ropivacaine 0.75% vs Ropivacaine 0.75% Plus Mepivacaine 1.5% for Subgluteal Sciatic Bloc: a Prospective Double Blind Randomized Controlled Study

Centre Hospitalier Universitaire, Amiens1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2007年9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
已完成
入组人数
30
试验地点
1
主要终点
Time of installation of a sensitive block compatible with surgery in the sciatic territory nerve

研究概览

简要总结

In loco regional anesthesia, much more than for general anesthesia, the choice of the product is largely left at the discretion of the practitioner. Two categories of local anesthetics are distinguished according to their pharmacodynamic characteristics: products with a short time of installation and a short duration period, and products with a longer delay of installation of the sensitive and motor block, but with a long-term duration. Indeed, the combined use of two products pharmacodynamically different seems to be of a practical interest.

This study provides a comparison of the onset of action of 30 ml of ropivacaine 0.75% and 30ml of a mixture of ropivacaïne 0.75% associated with mepivacaïne 1.5% for the subgluteal sciatic nerve block. This is a prospective randomized double-blind study where the main criterion of judgment is the time of installation of a sensitive block compatible with surgery in the sciatic territory nerve. Fifteen patients per group were calculated to detect a 50% decrease of the onset of action in the combination group with a power of 90% and alpha to 5%, according to a previous pilot study. The secondary endpoints are the intensity and time of installation of the motor block, the duration of sensitive and motor block, the total dose of morphine administered within 48 hours, as well as its possible side effects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Double (Participant, Care Provider)

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

  • age > 18 years
  • surgery of the foot under sciatic block

排除标准

  • no indication of locoregional anesthesia
  • polyneuropathy or any neurological disease
  • know hypersensitivity to local anesthetics
  • porphyria
  • atrio-ventricular block
  • not controlled epilepsia
  • hypovolemia
  • pregnancy
  • anticoagulant treatment

研究组 & 干预措施

B

Active Comparator

30ml of a mixture of ropivacaïne 0.75% associated with mepivacaïne 1.5%

干预措施: ropivacaine plus mepivacaine (Drug)

A

Experimental

30 ml of ropivacaine 0.75%

干预措施: ropivacaine (Drug)

结局指标

主要结局

Time of installation of a sensitive block compatible with surgery in the sciatic territory nerve

时间窗: 4h

次要结局

  • intensity and time of installation of the motor block, the duration of sensitive and motor block, the total dose of morphine administered within 48 hours, and its side effects.(48h)

研究者

申办方类型
Other

研究点 (1)

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