<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/NCT01719796</url>
  </required_header>
  <id_info>
    <org_study_id>KTAP</org_study_id>
    <nct_id>NCT01719796</nct_id>
  </id_info>
  <brief_title>Effect of TAP Block on Ventilatory Function Following Abdominal Surgery</brief_title>
  <acronym>KTAP</acronym>
  <official_title>Assessment of the Ventilatory Effects of Transverse Abdominal Plan Regional Analgesia Following Abdominal Surgery.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pierre and Marie Curie University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pierre and Marie Curie University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Abdominal surgery impairs ventilation. Postoperative pain accounts for this impairment.&#xD;
      Regional analgesia is known to reduce pain, thus to limit ventilatory impairment. The&#xD;
      investigators hypothesized bilateral continuous transverse abdominal plan block would reduce&#xD;
      ventilatory impairment following abdominal surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2012</start_date>
  <completion_date type="Anticipated">December 2014</completion_date>
  <primary_completion_date type="Anticipated">December 2014</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>vital capacity</measure>
    <time_frame>72h</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>maximum forced expiratory flow</measure>
    <time_frame>72h</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>analgesic consumption</measure>
    <time_frame>72h</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain</measure>
    <time_frame>72h</time_frame>
    <description>resting pain, assessed using VAS</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>diaphragmatic course</measure>
    <time_frame>72h</time_frame>
    <description>using ultrasonography</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Laparotomy</condition>
  <arm_group>
    <arm_group_label>Bilateral TAP catheter</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ultrasonography guided bilateral TAP catheter insertion.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No TAP catheter</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Regional analgesia infusion</intervention_name>
    <arm_group_label>Bilateral TAP catheter</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  laparotomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  below 18, pregnancy, prisoners&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mathieu RAUX, MD, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Pierre et Marie Curie University, Paris, France</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Mathieu RAUX, MD, PhD</last_name>
    <phone>+33142177379</phone>
    <email>mathieu.raux@psl.aphp.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Philippe CUVILLON, MD, PhD</last_name>
    <phone>+33675303395</phone>
    <email>philippe.cuvillon@chu-nimes.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Nîmes</name>
      <address>
        <city>Nîmes</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Philippe CUVILLON, MD, PhD</last_name>
      <phone>+33675303395</phone>
      <email>philippe.cuvillon@chu-nimes.fr</email>
    </contact>
    <investigator>
      <last_name>Philippe CUVILLON, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Saint-Etienne</name>
      <address>
        <city>Saint-Etienne</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Serge MOLLIEX, MD, PhD</last_name>
      <phone>+33477120922</phone>
      <email>serge.molliex@chu-st-etienne.fr</email>
    </contact>
    <investigator>
      <last_name>Serge MOLLIEX, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 1, 2012</study_first_posted>
  <last_update_submitted>October 30, 2012</last_update_submitted>
  <last_update_submitted_qc>October 30, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 1, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pierre and Marie Curie University</investigator_affiliation>
    <investigator_full_name>Mathieu RAUX</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <!-- 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/NCT01719796
org study id: KTAP
nct id: NCT01719796
lead sponsor: 
has dmc: No
Abdominal surgery impairs ventilation. Postoperative pain accounts for this impairment.
      Regional analgesia is known to reduce pain, thus to limit ventilatory impairment. The
      investigators hypothesized bilateral continuous transverse abdominal plan block would reduce
      ventilatory impairment following abdominal surgery.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: vital capacity
time frame: 72h
measure: maximum forced expiratory flow
time frame: 72h
measure: analgesic consumption
time frame: 72h
measure: pain
time frame: 72h
description: resting pain, assessed using VAS
measure: diaphragmatic course
time frame: 72h
description: using ultrasonography
arm group label: Bilateral TAP catheter
arm group type: Experimental
description: Ultrasonography guided bilateral TAP catheter insertion.
arm group label: No TAP catheter
arm group type: No Intervention
intervention type: Procedure
intervention name: Regional analgesia infusion
arm group label: Bilateral TAP catheter
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mathieu RAUX, MD, PhD
role: Study Director
affiliation: Pierre et Marie Curie University, Paris, France
last name: Mathieu RAUX, MD, PhD
phone: +33142177379
email: mathieu.raux@psl.aphp.fr
last name: Philippe CUVILLON, MD, PhD
phone: +33675303395
email: philippe.cuvillon@chu-nimes.fr
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Pierre and Marie Curie University
investigator full name: Mathieu RAUX
investigator title: Associate Professor