<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/NCT01679392</url>
  </required_header>
  <id_info>
    <org_study_id>H-1-2011-030</org_study_id>
    <secondary_id>2011-004719-22</secondary_id>
    <nct_id>NCT01679392</nct_id>
  </id_info>
  <brief_title>A Study Investigating Properties of the Transversus Abdominis Plane Block</brief_title>
  <official_title>Transversus Abdominis Plane Block: A Placebo-controlled Study in Healthy Volunteers</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hillerod Hospital, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hillerod Hospital, Denmark</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study we investigate the following properties of the transversus abdominis plane&#xD;
      block in healthy volunteers:&#xD;
&#xD;
        1. Cutaneous analgesic distribution&#xD;
&#xD;
        2. Muscular affection&#xD;
&#xD;
        3. Reproducibility&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Cutaneous analgesic distribution</measure>
    <time_frame>90 min</time_frame>
    <description>Cutaneous analgesic distribution 90 min after transversus abdominis plane block administration</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Muscular affection of the transversus abdominis plane block</measure>
    <time_frame>90 min</time_frame>
    <description>Abdominal wall muscle affection of the transversus abdominal plane block measured by ultrasonography under standardized conditions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reproducibility of the transversus abdominis plane block</measure>
    <time_frame>At least 2 days</time_frame>
    <description>Reproducibility of the transversus abdominis plane block with respect to:&#xD;
Cutaneous analgesic distribution&#xD;
Abdominal wall muscle affection measured in the same individual separated by at least 2 days</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Anesthesia, Local</condition>
  <arm_group>
    <arm_group_label>Ropivacaine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Unilateral transversus abdominis plane block with 20 ml ropivacaine (7.5 mg/ml)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ropivacaine</intervention_name>
    <description>Unilateral, single shot, ultrasound-guided, transversus abdominis plane block with 20 ml ropivacaine (7.5 mg/ml)</description>
    <arm_group_label>Ropivacaine</arm_group_label>
    <other_name>Naropin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Capable&#xD;
&#xD;
          -  American society of anesthesiologists classification 1 or 2&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age below 18 years&#xD;
&#xD;
          -  American society of anesthesiologists classification above 2&#xD;
&#xD;
          -  Body weight below 50 kg&#xD;
&#xD;
          -  Body mass index &gt; 35 kg/m2&#xD;
&#xD;
          -  Previous abdominal surgery&#xD;
&#xD;
          -  Acute or chronic pain&#xD;
&#xD;
          -  Use of pain medication less than 24 h prior to study start&#xD;
&#xD;
          -  Allergy to local anesthetics&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Breastfeeding&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kion Bo Støving, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hillerod Hospital, Denmark</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Charlotte Rosenstock, MD</last_name>
    <role>Study Director</role>
    <affiliation>Hillerod Hospital, Denmark</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kai Lange, MD</last_name>
    <role>Study Director</role>
    <affiliation>Hillerod Hospital, Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hillerød Hospital</name>
      <address>
        <city>Hillerød</city>
        <zip>3400</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>August 27, 2012</study_first_submitted>
  <study_first_submitted_qc>September 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 6, 2012</study_first_posted>
  <last_update_submitted>March 19, 2015</last_update_submitted>
  <last_update_submitted_qc>March 19, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 20, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hillerod Hospital, Denmark</investigator_affiliation>
    <investigator_full_name>Kai Henrik Wiborg Lange</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Transversus abdominis plane block</keyword>
  <keyword>Ultrasound guided nerve block</keyword>
  <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/NCT01679392
org study id: H-1-2011-030
secondary id: 2011-004719-22
nct id: NCT01679392
lead sponsor: 
has dmc: Yes
In this study we investigate the following properties of the transversus abdominis plane
      block in healthy volunteers:

        1. Cutaneous analgesic distribution

        2. Muscular affection

        3. Reproducibility
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Cutaneous analgesic distribution
time frame: 90 min
description: Cutaneous analgesic distribution 90 min after transversus abdominis plane block administration
measure: Muscular affection of the transversus abdominis plane block
time frame: 90 min
description: Abdominal wall muscle affection of the transversus abdominal plane block measured by ultrasonography under standardized conditions
measure: Reproducibility of the transversus abdominis plane block
time frame: At least 2 days
description: Reproducibility of the transversus abdominis plane block with respect to:
Cutaneous analgesic distribution
Abdominal wall muscle affection measured in the same individual separated by at least 2 days
arm group label: Ropivacaine
arm group type: Experimental
description: Unilateral transversus abdominis plane block with 20 ml ropivacaine (7.5 mg/ml)
intervention type: Drug
intervention name: Ropivacaine
description: Unilateral, single shot, ultrasound-guided, transversus abdominis plane block with 20 ml ropivacaine (7.5 mg/ml)
arm group label: Ropivacaine
other name: Naropin
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Kion Bo Støving, MD
role: Principal Investigator
affiliation: Hillerod Hospital, Denmark
last name: Charlotte Rosenstock, MD
role: Study Director
affiliation: Hillerod Hospital, Denmark
last name: Kai Lange, MD
role: Study Director
affiliation: Hillerod Hospital, Denmark
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Hillerod Hospital, Denmark
investigator full name: Kai Henrik Wiborg Lange
investigator title: Associate Professor
mesh term: Ropivacaine