<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/NCT03026543</url>
  </required_header>
  <id_info>
    <org_study_id>Regionostergotland</org_study_id>
    <nct_id>NCT03026543</nct_id>
  </id_info>
  <brief_title>Effect of Pulmonary Recruitment Maneuver (PRM) on Pain and Nausea After Laparoscopic Cholecystectomy</brief_title>
  <official_title>A Prospective, Blinded, Randomized Clinical Trial Investigating the Effect on Postoperative Pain and Nausea, When Performing a Ventilator-piloted PRM at the End of Laparoscopic Cholecystectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Region Östergötland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Region Östergötland</source>
  <brief_summary>
    <textblock>
      This prospective, blinded, randomized clinical trial investigates the effect on postoperative&#xD;
      pain and nausea, when performing a ventilator-piloted PRM at the end of a laparoscopic&#xD;
      cholecystectomy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2014</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2018</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>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in postoperative pain assessed with a numeric rating scale</measure>
    <time_frame>4, 12, 24, 36 and 48 hours after surgery</time_frame>
    <description>A questionnaire with a numeric rating scale (NRS) is used to assess pain intensity at 4, 12, 24, 36 and 48 hours postoperatively.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in postoperative nausea assessed with a Questionnaire</measure>
    <time_frame>4, 12, 24, 36 and 48 hours after surgery</time_frame>
    <description>A questionnaire is used to evaluate nausea at 4, 12, 24, 36 and 48 hours postoperatively.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">260</enrollment>
  <condition>Pain, Postoperative</condition>
  <condition>Postoperative Nausea and Vomiting</condition>
  <arm_group>
    <arm_group_label>Pulmonary recruitment maneuver</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One minute of ventilator-piloted PRM at the end of laparoscopic cholecystectomy, intending to remove residual carbon dioxide (CO2) from the abdomen.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Ordinary ventilation at the end of laparoscopic cholecystectomy.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pulmonary Recruitment Maneuver</intervention_name>
    <arm_group_label>Pulmonary recruitment maneuver</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Laparoscopic cholecystectomy</intervention_name>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Pulmonary recruitment maneuver</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ventilator</intervention_name>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Pulmonary recruitment maneuver</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  elective laparoscopic cholecystectomy&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) physical status classification I-II (with&#xD;
             the exception of body mass index over 35 kg/m2)&#xD;
&#xD;
          -  written consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  conversion to open surgery&#xD;
&#xD;
          -  Clavien-Dindo grade ≥ II&#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>Ebba Kihlstedt Pasquier, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Vrinnevi Hospital, Norrköping, Sweden</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ellen Andersson, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Vrinnevi Hospital, Norrköping, Sweden</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vrinnevi Hospital</name>
      <address>
        <city>Norrkoping</city>
        <state>Östergötland</state>
        <zip>603 79</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>January 12, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>May 6, 2019</last_update_submitted>
  <last_update_submitted_qc>May 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 7, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Region Östergötland</investigator_affiliation>
    <investigator_full_name>Ebba Kihlstedt Pasquier</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Nausea</mesh_term>
    <mesh_term>Vomiting</mesh_term>
    <mesh_term>Pain, Postoperative</mesh_term>
    <mesh_term>Postoperative Nausea and Vomiting</mesh_term>
  </condition_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/NCT03026543
org study id: Regionostergotland
nct id: NCT03026543
lead sponsor: 
This prospective, blinded, randomized clinical trial investigates the effect on postoperative
      pain and nausea, when performing a ventilator-piloted PRM at the end of a laparoscopic
      cholecystectomy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Care Provider, Investigator)
measure: Change in postoperative pain assessed with a numeric rating scale
time frame: 4, 12, 24, 36 and 48 hours after surgery
description: A questionnaire with a numeric rating scale (NRS) is used to assess pain intensity at 4, 12, 24, 36 and 48 hours postoperatively.
measure: Change in postoperative nausea assessed with a Questionnaire
time frame: 4, 12, 24, 36 and 48 hours after surgery
description: A questionnaire is used to evaluate nausea at 4, 12, 24, 36 and 48 hours postoperatively.
arm group label: Pulmonary recruitment maneuver
arm group type: Experimental
description: One minute of ventilator-piloted PRM at the end of laparoscopic cholecystectomy, intending to remove residual carbon dioxide (CO2) from the abdomen.
arm group label: Control group
arm group type: Active Comparator
description: Ordinary ventilation at the end of laparoscopic cholecystectomy.
intervention type: Procedure
intervention name: Pulmonary Recruitment Maneuver
arm group label: Pulmonary recruitment maneuver
intervention type: Procedure
intervention name: Laparoscopic cholecystectomy
arm group label: Control group
arm group label: Pulmonary recruitment maneuver
intervention type: Device
intervention name: Ventilator
arm group label: Control group
arm group label: Pulmonary recruitment maneuver
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ebba Kihlstedt Pasquier, MD
role: Principal Investigator
affiliation: Vrinnevi Hospital, Norrköping, Sweden
last name: Ellen Andersson, MD, PhD
role: Study Chair
affiliation: Vrinnevi Hospital, Norrköping, Sweden
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Region Östergötland
investigator full name: Ebba Kihlstedt Pasquier
investigator title: Principal Investigator
mesh term: Nausea
mesh term: Vomiting
mesh term: Pain, Postoperative
mesh term: Postoperative Nausea and Vomiting