Lidocaine Pharmacokinetics During Tumescent Infiltrative Anaesthesia for Mastectomy

Phase 3

Completed

• Conditions: Mastectomy
• Interventions: Drug: lidocaine aguettant

• Registration Number: NCT01687348
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-06-20
• Study First Submitted QC: 2012-09-17
• Study First Posted: 2012-09-18
• Study Start: 2012-11
• Status Verified: 2015-09
• Primary Completion: 2015-11
• Study Completion: 2015-12
• Last Update Submitted: 2016-01-22
• Last Update Posted: 2016-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
lidocaine	lidocaine aguettant	lidocaine traitment

Primary Outcome Measures

Name	Time	Method
Peak Plasma Concentration (Cmax) of 'drug lidocaine'"	36 MONTHS	during tumescent infiltrative anaesthesia for mastectomy.

Secondary Outcome Measures

Name	Time	Method
analgesic postoperative efficacy	36 MONTHS

Trial Locations

Locations (1)

Assistance Publique Hopitaux de Marseille; 🇫🇷 Marseille, France