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:||June 2012|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||June 2015 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01687348
|Contact: Bernard firstname.lastname@example.org|
|Assistance Publique Hopitaux de Marseille||Recruiting|
|Marseille, France, 13354|
|Contact: bernard bruguerolle email@example.com|
|Principal Investigator: bernard bruguerolle|
|Study Director:||BERNARD BELAIGUES||Assistance Publique hôpitaux de Marseille|