<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01687348</url>
  </required_header>
  <id_info>
    <org_study_id>2012-000817-36</org_study_id>
    <secondary_id>2012-05</secondary_id>
    <nct_id>NCT01687348</nct_id>
  </id_info>
  <brief_title>Lidocaine Pharmacokinetics During Tumescent Infiltrative Anaesthesia for Mastectomy</brief_title>
  <official_title>Lidocaine Pharmacokinetics During Tumescent Infiltrative Anaesthesia for Mastectomy.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique Hopitaux De Marseille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique Hopitaux De Marseille</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective, monocentric, open-label study conducted in women requiring mastectomy and&#xD;
      eligible for tumescent infiltrative anaesthesia.&#xD;
&#xD;
      Blood samples will be collected during 48h after start of infiltration. Total and free&#xD;
      lidocaine concentrations measurements will be determined by gas chromatography. Visual&#xD;
      analogic scale scores to evaluate postoperative pain and all data concerning analgesic drugs&#xD;
      and adverse effects will be collected.&#xD;
&#xD;
      Population pharmacokinetic parameters will be estimated using NONMEM software and covariates&#xD;
      influence on parameters variability will be tested.&#xD;
&#xD;
      Primary outcome value: Population pharmacokinetic parameters with possible covariates&#xD;
      influence on variability.&#xD;
&#xD;
      Patients and period of study: n=30 patients enrolled during 24 months, total study duration:&#xD;
      30 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Peak Plasma Concentration (Cmax) of 'drug lidocaine'&quot;</measure>
    <time_frame>36 MONTHS</time_frame>
    <description>during tumescent infiltrative anaesthesia for mastectomy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>analgesic postoperative efficacy</measure>
    <time_frame>36 MONTHS</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Mastectomy</condition>
  <arm_group>
    <arm_group_label>lidocaine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>lidocaine traitment</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>lidocaine aguettant</intervention_name>
    <arm_group_label>lidocaine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Surgery carcinologique of the breast requiring a mastectomy under tumescente local&#xD;
             anesthetic&#xD;
&#xD;
          -  Age: upper to 18 years&#xD;
&#xD;
          -  Weight: upper to 50 kg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cutaneous infection in the point of draining&#xD;
&#xD;
          -  Clinical Disorder(Confusion) of the coagulation&#xD;
&#xD;
          -  Retreat(Withdrawal) of the consent in the course of protocol&#xD;
&#xD;
          -  Unwanted Effect engraves(burns) requiring the stop(ruling) of the&#xD;
             treatment(processing)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>BERNARD BELAIGUES</last_name>
    <role>Study Director</role>
    <affiliation>Assistance Publique hôpitaux de Marseille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Assistance Publique Hopitaux de Marseille</name>
      <address>
        <city>Marseille</city>
        <zip>13354</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>June 20, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <last_update_submitted>January 22, 2016</last_update_submitted>
  <last_update_submitted_qc>January 22, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 25, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01687348
org study id: 2012-000817-36
secondary id: 2012-05
nct id: NCT01687348
lead sponsor: 
has dmc: No
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.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Peak Plasma Concentration (Cmax) of 'drug lidocaine'"
time frame: 36 MONTHS
description: during tumescent infiltrative anaesthesia for mastectomy.
measure: analgesic postoperative efficacy
time frame: 36 MONTHS
arm group label: lidocaine
arm group type: Experimental
description: lidocaine traitment
intervention type: Drug
intervention name: lidocaine aguettant
arm group label: lidocaine
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: BERNARD BELAIGUES
role: Study Director
affiliation: Assistance Publique hôpitaux de Marseille
facility: 
country: France
responsible party type: Sponsor
mesh term: Lidocaine