Lidocaine Pharmacokinetics During Tumescent Infiltrative... | NCT01687348

Studies
Lidocaine Pharmacokinetics During Tumescent Infiltrative Anaesthesia for Mastectomy

NCT01687348

Sponsor

Assistance Publique Hopitaux De Marseille

Status

Completed

Last Update Posted

May 8, 2026Actual

Enrollment

6Actual

Phase

Phase 3

Conditions

Mastectomy

Interventions

lidocaine aguettant

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2012-05	Other Identifier	AP HM

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2012

Primary Completion Date

Nov 2015Actual

Completion Date

Feb 28, 2017Actual

First Submitted Date

Jun 20, 2012

First Submission Date that Met QC Criteria

Sep 17, 2012

First Posted Date

Sep 18, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 4, 2026

Last Update Posted Date

May 8, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

6Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
lidocaine	Experimental	lidocaine traitment	Drug: lidocaine aguettant

Interventions

Name	Type	Description	Arm Group Labels	Other Names
lidocaine aguettant	Drug		lidocaine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Peak Plasma Concentration (Cmax) of 'drug lidocaine'"	during tumescent infiltrative anaesthesia for mastectomy.	36 MONTHS

Secondary Outcomes

Measure	Description	Time Frame
analgesic postoperative efficacy		36 MONTHS

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Surgery carcinologique of the breast requiring a mastectomy under tumescente local anesthetic
Age: upper to 18 years
Weight: upper to 50 kg

Exclusion Criteria:

Cutaneous infection in the point of draining
Clinical Disorder(Confusion) of the coagulation
Retreat(Withdrawal) of the consent in the course of protocol
Unwanted Effect engraves(burns) requiring the stop(ruling) of the treatment(processing)

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
BERNARD BELAIGUES	Assistance Publique hôpitaux de Marseille	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assistance Publique Hopitaux de Marseille		Marseille		13354	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29909577	Result	Riff C, Bourgoin A, Marsot A, Allanioux L, Leone M, Blin O, Guilhaumou R. Population pharmacokinetic model for tumescent lidocaine in women undergoing breast cancer surgery. Eur J Clin Pharmacol. 2018 Oct;74(10):1309-1315. doi: 10.1007/s00228-018-2503-8. Epub 2018 Jun 16.