Lidocaine Pharmacokinetics During Tumescent Infiltrative Anaesthesia for Mastectomy
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.
|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.|
- Peak Plasma Concentration (Cmax) of 'drug lidocaine'" [ Time Frame: 36 MONTHS ] [ Designated as safety issue: No ]during tumescent infiltrative anaesthesia for mastectomy.
- analgesic postoperative efficacy [ Time Frame: 36 MONTHS ] [ Designated as safety issue: No ]
|Study Start Date:||November 2012|
|Study Completion Date:||December 2015|
|Primary Completion Date:||November 2015 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01687348
|Assistance Publique Hopitaux de Marseille|
|Marseille, France, 13354|
|Study Director:||BERNARD BELAIGUES||Assistance Publique hôpitaux de Marseille|