<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/NCT02225418</url>
  </required_header>
  <id_info>
    <org_study_id>BBH-TQL-LC</org_study_id>
    <secondary_id>2013-001364-30</secondary_id>
    <nct_id>NCT02225418</nct_id>
  </id_info>
  <brief_title>Transmuscular Quadratus Lumborum Block for Laparoscopic Cholecystectomy</brief_title>
  <acronym>TQL</acronym>
  <official_title>Ultrasoundguided Transmuscular Quadratus Lumborum Block After Elective Laparoscopic Cholecystectomy. A Prospective, Randomized Clinical Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Jens Borglum Neimann</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bispebjerg Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Bispebjerg Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The TQL block may prove a valuable method for treating postoperative pain following scopic&#xD;
      removal of the gall bladder.&#xD;
&#xD;
      The trial will compare active TQL block versus placebo TQL block after said operation.&#xD;
&#xD;
      The hypothesis is that active TQL block significantly will reduce postoperative pain&#xD;
      following scopic removal of the gall bladder compared with placebo TQL block.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Change of jobs&#xD;
  </why_stopped>
  <start_date>November 2014</start_date>
  <primary_completion_date type="Anticipated">November 2015</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain score in sitting position</measure>
    <time_frame>1 hour</time_frame>
    <description>Numerical Rating Scale (NRS) score 1 hour after administration of TQL block</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain score at rest</measure>
    <time_frame>15 min, 30 min, 1 hour 2 hour 3 hour 4 hour 5 hour</time_frame>
    <description>NRS score after administration of TQL block at said time points</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain score at sitting position</measure>
    <time_frame>15 min 30 min 2 hour 3 hour 4 hour 5 hour</time_frame>
    <description>NRS score after administration of TQL block at said time points</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total opioid consumption in PACU area</measure>
    <time_frame>On average 3 hours</time_frame>
    <description>During stay in PACU area</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid side effects (nausea, vomiting)</measure>
    <time_frame>On average 3 hours</time_frame>
    <description>During stay in PACU area</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay in PACU area</measure>
    <time_frame>On average 3 hours</time_frame>
    <description>Total time in PACU area</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Cholecystitis</condition>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Placebo TQL block</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>30 ml single shot TQL block with saline 0,9%</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Active TQL block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>30 ml single shot TQL block with ropivacaine 0,75%</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ropivacaine</intervention_name>
    <arm_group_label>Active TQL block</arm_group_label>
    <other_name>naropin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>saline</intervention_name>
    <arm_group_label>Placebo TQL block</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  scheduled for elective laparoscopic cholecystectomy&#xD;
&#xD;
          -  received oral and written information about the trial&#xD;
&#xD;
          -  American Society of Anaethesiologists (ASA) classification 1-3&#xD;
&#xD;
          -  NRS score &gt; 3 upon arrival at the PACU area&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cannot cooperate&#xD;
&#xD;
          -  Does not speak or understand Danish&#xD;
&#xD;
          -  Allergy towards drugs used in the trial&#xD;
&#xD;
          -  Large daily consumption of opioids&#xD;
&#xD;
          -  Known alcohol og medicin abuse&#xD;
&#xD;
          -  Difficult or impossible by ultrasound to visualise the intended nerve/tissue&#xD;
             structures necessary to perform block&#xD;
&#xD;
          -  Pregnancy&#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>Jens Børglum, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Copenhagen University Hospital Bispebjerg</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Bispebjerg Hospital</name>
      <address>
        <city>Copenhagen</city>
        <zip>2400 NV</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>January 28, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 26, 2014</study_first_posted>
  <last_update_submitted>July 20, 2015</last_update_submitted>
  <last_update_submitted_qc>July 20, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 22, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Bispebjerg Hospital</investigator_affiliation>
    <investigator_full_name>Jens Borglum Neimann</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <keyword>Laparoscopic</keyword>
  <keyword>Cholecystectomy</keyword>
  <keyword>Postoperative</keyword>
  <keyword>Pain</keyword>
  <keyword>Quadratus lumborum</keyword>
  <keyword>Ultrasound</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholecystitis</mesh_term>
  </condition_browse>
  <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/NCT02225418
org study id: BBH-TQL-LC
secondary id: 2013-001364-30
nct id: NCT02225418
lead sponsor: 
collaborator: 
has dmc: Yes
The TQL block may prove a valuable method for treating postoperative pain following scopic
      removal of the gall bladder.

      The trial will compare active TQL block versus placebo TQL block after said operation.

      The hypothesis is that active TQL block significantly will reduce postoperative pain
      following scopic removal of the gall bladder compared with placebo TQL block.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Pain score in sitting position
time frame: 1 hour
description: Numerical Rating Scale (NRS) score 1 hour after administration of TQL block
measure: Pain score at rest
time frame: 15 min, 30 min, 1 hour 2 hour 3 hour 4 hour 5 hour
description: NRS score after administration of TQL block at said time points
measure: Pain score at sitting position
time frame: 15 min 30 min 2 hour 3 hour 4 hour 5 hour
description: NRS score after administration of TQL block at said time points
measure: Total opioid consumption in PACU area
time frame: On average 3 hours
description: During stay in PACU area
measure: Opioid side effects (nausea, vomiting)
time frame: On average 3 hours
description: During stay in PACU area
measure: Length of stay in PACU area
time frame: On average 3 hours
description: Total time in PACU area
arm group label: Placebo TQL block
arm group type: Sham Comparator
description: 30 ml single shot TQL block with saline 0,9%
arm group label: Active TQL block
arm group type: Active Comparator
description: 30 ml single shot TQL block with ropivacaine 0,75%
intervention type: Drug
intervention name: Ropivacaine
arm group label: Active TQL block
other name: naropin
intervention type: Drug
intervention name: saline
arm group label: Placebo TQL block
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jens Børglum, MD, PhD
role: Principal Investigator
affiliation: Copenhagen University Hospital Bispebjerg
facility: 
country: Denmark
responsible party type: Sponsor-Investigator
investigator affiliation: Bispebjerg Hospital
investigator full name: Jens Borglum Neimann
investigator title: Associate professor
mesh term: Cholecystitis
mesh term: Ropivacaine