Pharmacokinetic of levobupivacaïne After Sciatic Nerve Block in Children

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00682344

Enrollment

Registered

2008-05-22

Start date

2008-01-31

Completion date

2012-01-31

Last updated

2014-08-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Surgical Pathology of the Leg or the Foot.

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.

Interventions

DRUGLevobupivacaïne

1,75mg/kg

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Months to 12 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026