Pharmacokinetic of levobupivacaïne After Sciatic Nerve Block in Children
Recruitment status was Recruiting
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).
Surgical Pathology of the Leg or the Foot.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Pharmacokinetic of levobupivacaïne After Sciatic Nerve Block in Children|
- 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. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
- 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. [ Time Frame: 24 months ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2008|
|Estimated Study Completion Date:||July 2012|
|Estimated Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00682344
|Contact: Frédéric LACROIX, MD||33 4 91 38 68 email@example.com|
|Contact: Frédéric BLANC, MD||33 4 91 38 48 firstname.lastname@example.org|
|Hôpital de la Timone - Pôle d'anesthésie réanimation pédiatrique||Recruiting|
|Marseille, France, 13005|
|Contact: Frédéric LACROIX, MD 33 4 91 38 68 42|
|Principal Investigator:||Frédéric LACROIX, MD||ASSISTANCE PUBLIQUE DES HOPITAUX DE MARSEILLE|