Lidocaine Pharmacokinetics During Tumescent Infiltrative Anaesthesia for Mastectomy
|ClinicalTrials.gov Identifier: NCT01687348|
Recruitment Status : Completed
First Posted : September 18, 2012
Last Update Posted : January 25, 2016
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 or disease||Intervention/treatment||Phase|
|Mastectomy||Drug: lidocaine aguettant||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Lidocaine Pharmacokinetics During Tumescent Infiltrative Anaesthesia for Mastectomy.|
|Study Start Date :||November 2012|
|Primary Completion Date :||November 2015|
|Study Completion Date :||December 2015|
|Drug: lidocaine aguettant|
- Peak Plasma Concentration (Cmax) of 'drug lidocaine'" [ Time Frame: 36 MONTHS ]during tumescent infiltrative anaesthesia for mastectomy.
- analgesic postoperative efficacy [ Time Frame: 36 MONTHS ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01687348
|Assistance Publique Hopitaux de Marseille|
|Marseille, France, 13354|
|Study Director:||BERNARD BELAIGUES||Assistance Publique hôpitaux de Marseille|