NCT01687348

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2012

Typical duration for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2012

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 18, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2012

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 25, 2016

Status Verified

September 1, 2015

Enrollment Period

3 years

First QC Date

June 20, 2012

Last Update Submit

January 22, 2016

Conditions

Mastectomy

Outcome Measures

Primary Outcomes (1)

  • Peak Plasma Concentration (Cmax) of 'drug lidocaine'"

    during tumescent infiltrative anaesthesia for mastectomy.

    36 MONTHS

Secondary Outcomes (1)

  • analgesic postoperative efficacy

    36 MONTHS

Study Arms (1)

lidocaine

EXPERIMENTAL

lidocaine traitment

Drug: lidocaine aguettant

Interventions

lidocaine aguettantDRUG
lidocaine

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hopitaux de Marseille

Marseille, 13354, France

Location

Study Officials

  • BERNARD BELAIGUES

    Assistance Publique hôpitaux de Marseille

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 20, 2012

First Posted

September 18, 2012

Study Start

November 1, 2012

Primary Completion

November 1, 2015

Study Completion

December 1, 2015

Last Updated

January 25, 2016

Record last verified: 2015-09

Locations

FR(1)