Lidocaine Pharmacokinetics During Tumescent Infiltrative Anaesthesia for Mastectomy.

NCT01687348 Phase 3 COMPLETED

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.

Details

Lead sponsor	Assistance Publique Hopitaux De Marseille
Phase	Phase 3
Status	COMPLETED
Enrolment	6
Start date	2012-11
Completion	2017-02-28

Conditions

• Mastectomy

Interventions

• lidocaine aguettant

Primary outcomes

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

Countries

France