Pharmacokinetic of levobupivacaïne After Sciatic Nerve Block in Children

Phase 3

Terminated

• Conditions: Surgical Pathology of the Leg or the Foot.

• Registration Number: NCT00682344
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

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).

Detailed Description

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.

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-05-16
• Study First Submitted QC: 2008-05-20
• Study First Posted: 2008-05-22
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-27
• Last Update Posted: 2014-08-28

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 7

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.	24 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Hôpital de la Timone - Pôle d'anesthésie réanimation pédiatrique; 🇫🇷 Marseille, France