Pharmacokinetic of levobupivacaïne After Sciatic Nerve Block in Children
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- The purpose of this work is to describe the pharmacokinetics characteristics by the levobupivacaine after peripheral block by using the principle of the pharmacology of population, this allowing fewer sampling of blood by patients.
研究概览
简要总结
Levobupivacaïne (Chirocaine®) is a new local anaesthetic recently marketed in France. The goal of this prospective work is to study the pharmacokinetic aspect of this drug after injection around the sciatic nerve (subgluteal way).
详细描述
The originality of this work is to call upon a modelling of pharmacokinetic by using the principle of the pharmacology of population.
This work also proposes to appreciate a dynamic aspect since data of effectiveness and tolerance will be collected with regular intervals during the first 24 hours after the beginning of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 6 Months 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Surgical pathology of the leg or the foot with garot tyre of thigh
- •Age included between 6 months and 12 years
- •Status ASA I or II
排除标准
- •Bilateral or one-sided surgical gesture realized without garot tyre
- •Cutaneous infection in the point of draining
- •Clinical confusion of the coagulation
- •Allergy informed in the local anesthesics of amino-acid class
- •Evolutionary neurological pathology of the operated limb
- •Renal, respiratory, cardiac or hepatic insufficiency.
结局指标
主要结局
The purpose of this work is to describe the pharmacokinetics characteristics by the levobupivacaine after peripheral block by using the principle of the pharmacology of population, this allowing fewer sampling of blood by patients.
时间窗: 24 months
次要结局
- Appreciation, by the anaesthetist in charge of the patient, of the quality of the "surgical" analgesia during the surgery by: very effective, effective, ineffective. Measure of the delay of appeal of the first one bolus of morphine.(24 months)