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NCT01687348 Clinical Trial

Lidocaine Pharmacokinetics During Tumescent Infiltrative Anaesthesia for Mastectomy

Mastectomy Clinical Trial

Official title:
Lidocaine Pharmacokinetics During Tumescent Infiltrative Anaesthesia for Mastectomy.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01687348
Other study ID # 2012-000817-36
Secondary ID 2012-05
Status Completed
Phase Phase 3
First received June 20, 2012
Last updated January 22, 2016
Start date November 2012
Est. completion date December 2015

Study information
Verified date September 2015
Source Assistance Publique Hopitaux De Marseille
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date December 2015
Est. primary completion date November 2015
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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)

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• lidocaine aguettant

Locations
Country Name City State
France Assistance Publique Hopitaux de Marseille Marseille

Sponsors (1)
Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Peak Plasma Concentration (Cmax) of 'drug lidocaine'" during tumescent infiltrative anaesthesia for mastectomy. 36 MONTHS No
Secondary analgesic postoperative efficacy 36 MONTHS No
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