Lidocaine Pharmacokinetics During Tumescent Infiltrative Anaesthesia for Mastectomy

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Assistance Publique Hopitaux De Marseille
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier:
NCT01687348
First received: June 20, 2012
Last updated: August 27, 2014
Last verified: August 2014
  Purpose

Prospective, monocentric, open-label study conducted in women requiring mastectomy and eligible for tumescent infiltrative anaesthesia.

Blood samples will be collected during 48h after start of infiltration. Total and free lidocaine concentrations measurements will be determined by gas chromatography. Visual analogic scale scores to evaluate postoperative pain and all data concerning analgesic drugs and adverse effects will be collected.

Population pharmacokinetic parameters will be estimated using NONMEM software and covariates influence on parameters variability will be tested.

Primary outcome value: Population pharmacokinetic parameters with possible covariates influence on variability.

Patients and period of study: n=30 patients enrolled during 24 months, total study duration: 30 months.


Condition Intervention Phase
Mastectomy
Drug: lidocaine aguettant
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Lidocaine Pharmacokinetics During Tumescent Infiltrative Anaesthesia for Mastectomy.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Peak Plasma Concentration (Cmax) of 'drug lidocaine'" [ Time Frame: 36 MONTHS ] [ Designated as safety issue: No ]
    during tumescent infiltrative anaesthesia for mastectomy.


Secondary Outcome Measures:
  • analgesic postoperative efficacy [ Time Frame: 36 MONTHS ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: June 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: lidocaine Drug: lidocaine aguettant

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Surgery carcinologique of the breast requiring a mastectomy under tumescente local anesthetic
  • Age: upper to 18 years
  • Weight: upper to 50 kg

Exclusion Criteria:

  • Cutaneous infection in the point of draining
  • Clinical Disorder(Confusion) of the coagulation
  • Retreat(Withdrawal) of the consent in the course of protocol
  • Unwanted Effect engraves(burns) requiring the stop(ruling) of the treatment(processing)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01687348

Contacts
Contact: Bernard bruguerolle bernard.bruguerolle@ap-hm.fr

Locations
France
Assistance Publique Hopitaux de Marseille Recruiting
Marseille, France, 13354
Contact: bernard bruguerolle       bernard.bruguerolle@ap-hm.fr   
Principal Investigator: bernard bruguerolle         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
Study Director: BERNARD BELAIGUES Assistance Publique hôpitaux de Marseille
  More Information

No publications provided

Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT01687348     History of Changes
Other Study ID Numbers: 2012-000817-36, 2012-05
Study First Received: June 20, 2012
Last Updated: August 27, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Lidocaine
Anesthetics
Anesthetics, Local
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on October 23, 2014