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Pharmacokinetic of levobupivacaïne After Sciatic Nerve Block in Children

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Assistance Publique Hopitaux De Marseille.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT00682344
First received: May 16, 2008
Last updated: January 26, 2010
Last verified: January 2010
History of Changes
  Purpose

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).


Condition Intervention Phase
Surgical Pathology of the Leg or the Foot.
 Drug: Levobupivacaïne
 Phase 3

Study Type: Interventional
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

Resource links provided by NLM:

MedlinePlus related topics: Foot Health
U.S. FDA Resources

Further study details as provided by Assistance Publique Hopitaux De Marseille:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 27
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)
Intervention Details:
    Drug: Levobupivacaïne
    1,75mg/kg
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.

  Eligibility

Ages Eligible for Study:   6 Months to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00682344

Contacts
Contact: Frédéric LACROIX, MD 33 4 91 38 68 42 frederic.lacroix@ap-hm.fr
Contact: Frédéric BLANC, MD 33 4 91 38 48 67 frederic.blanc@ap-hm.fr

Locations
France
Hôpital de la Timone - Pôle d'anesthésie réanimation pédiatrique Recruiting
Marseille, France, 13005
Contact: Frédéric LACROIX, MD     33 4 91 38 68 42        
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Principal Investigator: Frédéric LACROIX, MD ASSISTANCE PUBLIQUE DES HOPITAUX DE MARSEILLE
  More Information

No publications provided

Responsible Party: ASSISTANCE PUBLIQUE DES HOPITAUX DE MARSEILLE
ClinicalTrials.gov Identifier: NCT00682344     History of Changes
Other Study ID Numbers: 2007-000796-42, 2007-08
Study First Received: May 16, 2008
Last Updated: January 26, 2010
Health Authority: France: Ministry of Health

Additional relevant MeSH terms:
Levobupivacaine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
 Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013