<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/NCT02184559</url>
  </required_header>
  <id_info>
    <org_study_id>2011-005690-23</org_study_id>
    <secondary_id>2011-38</secondary_id>
    <nct_id>NCT02184559</nct_id>
  </id_info>
  <brief_title>Postoperative Analgesia After Caesarean Section Under ALR: TAP Block Versus Catheter Scar Infiltration</brief_title>
  <official_title>Postoperative Analgesia After Caesarean Section Under ALR: TAP Block Versus Catheter Scar Infiltration</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>
      The purpose of the multimodal postoperative analgesia is to improve the quality of analgesia&#xD;
      and reduce side effects of morphine (nausea, vomiting, sedation, urinary retention,&#xD;
      respiratory depression ...). In the case of caesarean sections, the quality of analgesia&#xD;
      allows one hand to improve the mother-child relationship and the quality of breastfeeding,&#xD;
      the other to reduce the risk of postpartum depression and chronic pain . Two methods of&#xD;
      administration of local anesthetics have been proven effective for analgesia of the abdominal&#xD;
      wall under umbilical: The Transversus Abdominal Block Plan (TAP Block) and infiltration of&#xD;
      the scar continues operating. The TAP block was performed under ultrasound guidance by the&#xD;
      anesthesiologist after the intervention in a single injection of local anesthetic in the&#xD;
      abdominal wall and has a period of limited and variable. The infiltration continues catheter&#xD;
      is placed by the surgeon before closing the wound and allows the infusion of local&#xD;
      anesthetics for 48 hours.&#xD;
&#xD;
      The purpose of this study was to compare morphine consumption between both techniques, and&#xD;
      the quality of analgesia and side effects of morphine&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>February 2012</start_date>
  <completion_date type="Anticipated">February 2015</completion_date>
  <primary_completion_date type="Anticipated">August 2014</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Consumption morphinize</measure>
    <time_frame>48 hours</time_frame>
    <description>the cosumption of morphinize is collected since the first hours of comsumption to the 48 th hours</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Analgesic efficiency</measure>
    <time_frame>48 hours</time_frame>
    <description>the Score of pain measured by simple numerical rating scales start the first hours one asks for a complementary analgesia to the 48 th hours</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Scheduled Caesarian Section</condition>
  <arm_group>
    <arm_group_label>TAP block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>infiltration continues</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ropivacaine</intervention_name>
    <description>comparaison of two methods of administration for analgesia using the same drugs in the same indication after Caesarean section</description>
    <arm_group_label>TAP block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>The infiltration continues catheter</intervention_name>
    <arm_group_label>infiltration continues</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Woman whose age is 18 years&#xD;
&#xD;
          -  Encircled Woman requiring a scheduled(programmed) caesarian, under spinal anesthesia&#xD;
             or died combined(organized) spinal anesthesia&#xD;
&#xD;
          -  Woman ASA I and II&#xD;
&#xD;
          -  Term = 37 LIMITED COMPANIES&#xD;
&#xD;
          -  Woman primipare or not&#xD;
&#xD;
          -  Woman having signed an informed consent writes and making a commitment to respect the&#xD;
             instructions of the protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Minor Woman&#xD;
&#xD;
          -  Woman presenting a contraindication to the anesthesia périmédullaire: constitutional&#xD;
             or acquired disorders(confusions) of the haemostasis, the allergy in the local&#xD;
             anesthetics, the infectious context (hypertherm &gt; 38.5 ° C)&#xD;
&#xD;
          -  Woman presenting an intolerance or an allergy known about the morphine in the&#xD;
             paracetamol or in AIN&#xD;
&#xD;
          -  The surgical histories of laparotomy&#xD;
&#xD;
          -  The morbid obesity BMI &gt; 35&#xD;
&#xD;
          -  Dysgravidies&#xD;
&#xD;
          -  Woman not being affiliated to the national insurance scheme&#xD;
&#xD;
          -  Woman under legal protection&#xD;
&#xD;
          -  Woman not having signed an informed consent&#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>loic MONDOLONI</last_name>
    <role>Study Director</role>
    <affiliation>Assistance Publique Hopitaux De Marseille</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>aurelie BOURGOIN</last_name>
    <email>aurelie.bourgoin@ap-hm.fr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Assistance Publique Hopitaux de Marseille</name>
      <address>
        <city>Marseille</city>
        <zip>13354</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>aurelie BOURGOIN</last_name>
      <email>aurelie.bourgoin@ap-hm.fr</email>
    </contact>
    <investigator>
      <last_name>aurelie BOURGOIN</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>June 25, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>July 8, 2014</last_update_submitted>
  <last_update_submitted_qc>July 8, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 9, 2014</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>Ropivacaine</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/NCT02184559
org study id: 2011-005690-23
secondary id: 2011-38
nct id: NCT02184559
lead sponsor: 
has dmc: No
The purpose of the multimodal postoperative analgesia is to improve the quality of analgesia
      and reduce side effects of morphine (nausea, vomiting, sedation, urinary retention,
      respiratory depression ...). In the case of caesarean sections, the quality of analgesia
      allows one hand to improve the mother-child relationship and the quality of breastfeeding,
      the other to reduce the risk of postpartum depression and chronic pain . Two methods of
      administration of local anesthetics have been proven effective for analgesia of the abdominal
      wall under umbilical: The Transversus Abdominal Block Plan (TAP Block) and infiltration of
      the scar continues operating. The TAP block was performed under ultrasound guidance by the
      anesthesiologist after the intervention in a single injection of local anesthetic in the
      abdominal wall and has a period of limited and variable. The infiltration continues catheter
      is placed by the surgeon before closing the wound and allows the infusion of local
      anesthetics for 48 hours.

      The purpose of this study was to compare morphine consumption between both techniques, and
      the quality of analgesia and side effects of morphine
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Consumption morphinize
time frame: 48 hours
description: the cosumption of morphinize is collected since the first hours of comsumption to the 48 th hours
measure: Analgesic efficiency
time frame: 48 hours
description: the Score of pain measured by simple numerical rating scales start the first hours one asks for a complementary analgesia to the 48 th hours
arm group label: TAP block
arm group type: Experimental
arm group label: infiltration continues
arm group type: Active Comparator
intervention type: Drug
intervention name: Ropivacaine
description: comparaison of two methods of administration for analgesia using the same drugs in the same indication after Caesarean section
arm group label: TAP block
intervention type: Device
intervention name: The infiltration continues catheter
arm group label: infiltration continues
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: loic MONDOLONI
role: Study Director
affiliation: Assistance Publique Hopitaux De Marseille
last name: aurelie BOURGOIN
email: aurelie.bourgoin@ap-hm.fr
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Ropivacaine