NCT01687348

Lidocaine Pharmacokinetics During Tumescent Infiltrative Anaesthesia for Mastectomy

Lidocaine Pharmacokinetics During Tumescent Infiltrative Anaesthesia for Mastectomy.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Assistance Publique Hopitaux De Marseille · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Mastectomy

Interventions

Type	Name	Description
DRUG	lidocaine aguettant

Timeline

• Start date: 2012-11-01
• Primary completion: 2015-11-01
• Completion: 2015-12-01
• First posted: 2012-09-18
• Last updated: 2016-01-25

Locations

1 site across 1 country: France