xml: <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/NCT06039761</url>
    </required_header>
    <id_info>
      <org_study_id>2023-A01281-44</org_study_id>
      <nct_id>NCT06039761</nct_id>
    </id_info>
    <brief_title>Randomized Study in the Prevention of Pain Shoulders After Laparoscopic Surgery</brief_title>
    <acronym>POPPLaS</acronym>
    <official_title>Randomized Study Comparing the Combination Intraperitoneal Local Anesthetics, Maneuvers Alveolar Recruitment and Abdominal Compression Compared to Passive Exsufflation of the Pneumoperitoneum in the Prevention of Pain Shoulders After Laparoscopic Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>GCS Ramsay Santé pour l'Enseignement et la Recherche</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>GCS Ramsay Santé pour l'Enseignement et la Recherche</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this study is to assess shoulder pain at rest (average over the last 24 hours)&#xD;
        assessed by visual analogue scale from 0 to 100mm on Day 1.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is an interventional, comparative, controlled, randomized, single-blind study (the&#xD;
        patient will be blinded to the result of the randomization, unlike the investigator) and&#xD;
        single-center.&#xD;
  &#xD;
        Comparative prospective cohort study of laparoscopic surgery with the addition of specific&#xD;
        non-surgical interventions aimed at preventing postoperative shoulder pain (use of local&#xD;
        intraperitoneal anesthetics, alveolar recruitment maneuver and compression maneuver&#xD;
        abdominal) versus without specific interventions aimed at preventing post-operative shoulder&#xD;
        pain.&#xD;
  &#xD;
        All patients will benefit from Transversus Abdominis Plane block with multimodal analgesia&#xD;
        provided in the usual setting of laparoscopic surgery.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">March 2024</completion_date>
    <primary_completion_date type="Anticipated">March 2024</primary_completion_date>
    <phase>N/A</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>
      <intervention_model_description>Study patients will be divided into 2 arms (1:1) and will benefit from one of the following procedures:&#xD;
  Arm A (experimental): Overall procedure = standard procedure + local intraperitoneal anesthetics + alveolar recruitment maneuver + abdominal compression maneuver.&#xD;
  Arm B (control): Standard procedure.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>The patient will be blinded to the result of the randomization, unlike the investigator.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Shoulder pain at rest assessed by visual analog scale</measure>
      <time_frame>1 day</time_frame>
      <description>Shoulder pain at rest (average over the last 24 hours) assessed by visual analog scale from 0 to 100mm.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">190</enrollment>
    <condition>Shoulder Pain</condition>
    <arm_group>
      <arm_group_label>local intraperitoneal anesthetics + alveolar recruitment maneuver + abdominal compression maneuver</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Overall Procedure : The specific interventions are carried out at the end of the surgical intervention and include the use of intraperitoneal local anesthetics insufflated by the surgeon, the alveolar recruitment maneuver carried out by the anesthetist and that of abdominal compression carried out by the surgeon.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard Procedure</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Standard Procedure : Digestive or gynecological surgery by laparoscopy with a Transversus abdominis plane block before the incision and systematic standardized multimodal analgesia.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Digestive or gynecological surgery by laparoscopy</intervention_name>
      <description>Digestive or gynecological surgery by laparoscopy with a Transversus abdominis plane block before the incision and systematic standardized multimodal analgesia</description>
      <arm_group_label>Standard Procedure</arm_group_label>
      <arm_group_label>local intraperitoneal anesthetics + alveolar recruitment maneuver + abdominal compression maneuver</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥ 18 years;&#xD;
  &#xD;
            -  Celiosurgery including a Transversus Abdominis Plane block with multimodal analgesia;&#xD;
  &#xD;
            -  Planned laparoscopic surgery for gallbladder, inguinal hernia, umbilical hernia,&#xD;
               incisional hernia repair, adnexectomy, oophorectomy, endometriosis, tube ligation;&#xD;
  &#xD;
            -  Affiliation to the social security scheme;&#xD;
  &#xD;
            -  Signed informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Celiosurgery such as colectomy, bariatric surgery, hysterectomy, prostatectomy,&#xD;
               nephrectomy;&#xD;
  &#xD;
            -  Surgical emergency;&#xD;
  &#xD;
            -  History of chronic obstructive pulmonary disease;&#xD;
  &#xD;
            -  Weight less than 50 kg;&#xD;
  &#xD;
            -  Consumption of preoperative opioids;&#xD;
  &#xD;
            -  Antidepressant treatment and/or anxiolytic treatment;&#xD;
  &#xD;
            -  Conversion by laparotomy;&#xD;
  &#xD;
            -  Intraperitoneal sepsis;&#xD;
  &#xD;
            -  Major intraoperative complication (hemorrhage, anaphylaxis, etc.);&#xD;
  &#xD;
            -  Other surgical or medical interventions planned during the study;&#xD;
  &#xD;
            -  Patient participating in another clinical trial, or during a period of exclusion from&#xD;
               another clinical trial;&#xD;
  &#xD;
            -  Inability to understand information related to the study;&#xD;
  &#xD;
            -  Woman who is pregnant or likely to be pregnant (of childbearing age, without effective&#xD;
               contraception) or currently breastfeeding;&#xD;
  &#xD;
            -  Patient deprived of liberty or under guardianship or curatorship or unable to give&#xD;
               consent.&#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_contact>
      <last_name>Fabien DECHANET, MD</last_name>
      <phone>6 12 85 91 37</phone>
      <phone_ext>+33</phone_ext>
      <email>dechanet.fabien@hotmail.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Hôpital Privé Dijon Bourgogne</name>
        <address>
          <city>Dijon</city>
          <zip>21000</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Fabien DECHANET, MD</last_name>
        <phone>6 12 85 91 37</phone>
        <phone_ext>+33</phone_ext>
        <email>dechanet.fabien@hotmail.fr</email>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 8, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Shoulder Pain</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06039761
  org study id: 2023-A01281-44
  nct id: NCT06039761
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to assess shoulder pain at rest (average over the last 24 hours)
        assessed by visual analogue scale from 0 to 100mm on Day 1.
  This is an interventional, comparative, controlled, randomized, single-blind study (the
        patient will be blinded to the result of the randomization, unlike the investigator) and
        single-center.
  
        Comparative prospective cohort study of laparoscopic surgery with the addition of specific
        non-surgical interventions aimed at preventing postoperative shoulder pain (use of local
        intraperitoneal anesthetics, alveolar recruitment maneuver and compression maneuver
        abdominal) versus without specific interventions aimed at preventing post-operative shoulder
        pain.
  
        All patients will benefit from Transversus Abdominis Plane block with multimodal analgesia
        provided in the usual setting of laparoscopic surgery.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Study patients will be divided into 2 arms (1:1) and will benefit from one of the following procedures:
  Arm A (experimental): Overall procedure = standard procedure + local intraperitoneal anesthetics + alveolar recruitment maneuver + abdominal compression maneuver.
  Arm B (control): Standard procedure.
  primary purpose: Treatment
  masking: Single (Participant)
  masking description: The patient will be blinded to the result of the randomization, unlike the investigator.
  measure: Shoulder pain at rest assessed by visual analog scale
  time frame: 1 day
  description: Shoulder pain at rest (average over the last 24 hours) assessed by visual analog scale from 0 to 100mm.
  arm group label: local intraperitoneal anesthetics + alveolar recruitment maneuver + abdominal compression maneuver
  arm group type: Experimental
  description: Overall Procedure : The specific interventions are carried out at the end of the surgical intervention and include the use of intraperitoneal local anesthetics insufflated by the surgeon, the alveolar recruitment maneuver carried out by the anesthetist and that of abdominal compression carried out by the surgeon.
  arm group label: Standard Procedure
  arm group type: Active Comparator
  description: Standard Procedure : Digestive or gynecological surgery by laparoscopy with a Transversus abdominis plane block before the incision and systematic standardized multimodal analgesia.
  intervention type: Procedure
  intervention name: Digestive or gynecological surgery by laparoscopy
  description: Digestive or gynecological surgery by laparoscopy with a Transversus abdominis plane block before the incision and systematic standardized multimodal analgesia
  arm group label: Standard Procedure
  arm group label: local intraperitoneal anesthetics + alveolar recruitment maneuver + abdominal compression maneuver
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Fabien DECHANET, MD
  phone: 6 12 85 91 37
  phone ext: +33
  email: dechanet.fabien@hotmail.fr
  facility: 
  contact: 
  country: France
  responsible party type: Sponsor
  mesh term: Shoulder Pain