<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/NCT02196727</url>
  </required_header>
  <id_info>
    <org_study_id>BPP</org_study_id>
    <nct_id>NCT02196727</nct_id>
  </id_info>
  <brief_title>Evaluation of Postoperative Pain Following Bascom Cleft Lift Operation</brief_title>
  <official_title>Evaluation of Post-operative Pain in Bascom Cleft Lift Operation Receiving Multimodal Analgesia and Spinal Saddle Block in Day Case Surgery Setting.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hvidovre University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hvidovre University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate postoperative pain in Bascom Cleft Lift operation&#xD;
      receiving multimodal analgesia in day-case surgery setting.&#xD;
&#xD;
      Hypothesis: Multimodal analgesia provides adequate pain relief in patients undergoing Bascom&#xD;
      Cleft Lift operation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2013</start_date>
  <completion_date type="Actual">April 2014</completion_date>
  <primary_completion_date type="Actual">January 2014</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>1 Month</target_duration>
  <primary_outcome>
    <measure>Numerical Rating Scale (NRS) pain score (0=no pain, 10= maximum imaginable pain)</measure>
    <time_frame>24 hours postoperatively</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Numerical Rating Scale (NRS) pain score (0=no pain, 10= maximum imaginable pain)</measure>
    <time_frame>2 hours, 48 hours and 30 days postoperatively</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Nausea</measure>
    <time_frame>2 hours postoperatively</time_frame>
    <description>Scale (0= non, 1= mild, 2= moderate, 3= severe)</description>
  </other_outcome>
  <other_outcome>
    <measure>Returning to work</measure>
    <time_frame>30 days</time_frame>
    <description>Questionnaire: &quot;Yes&quot; or &quot;No&quot;</description>
  </other_outcome>
  <other_outcome>
    <measure>Returning to leisure activities</measure>
    <time_frame>30 days</time_frame>
    <description>Questionnaire: &quot;Yes&quot; or &quot;No&quot;</description>
  </other_outcome>
  <other_outcome>
    <measure>Wound condition</measure>
    <time_frame>30 days</time_frame>
    <description>Wound inspection for healing problems or infection</description>
  </other_outcome>
  <other_outcome>
    <measure>Vomiting</measure>
    <time_frame>2 hours postoperatively</time_frame>
    <description>Scale (0= non, 1= mild, 2= moderate, 3= severe)</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">32</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>Patients undergoing Bascom operation</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing Bascom Cleft Lift operation in a day-case surgery setting&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18&#xD;
&#xD;
          -  ASA physical status 1 and 2&#xD;
&#xD;
          -  Patient undergoing Bascom operation in prone position&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Current regular use of drug belonging to the class of opioids&#xD;
&#xD;
          -  Allergy/ intolerance to drugs included in multimodal analgesia regime&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hvidovre Univarsity Hospital</name>
      <address>
        <city>Hvidovre</city>
        <state>Copenhagen</state>
        <zip>2650</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>May 2013</verification_date>
  <study_first_submitted>July 18, 2014</study_first_submitted>
  <study_first_submitted_qc>July 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <last_update_submitted>July 21, 2014</last_update_submitted>
  <last_update_submitted_qc>July 21, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 22, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hvidovre University Hospital</investigator_affiliation>
    <investigator_full_name>Saphana Jassim Mohamed</investigator_full_name>
    <investigator_title>Consultant</investigator_title>
  </responsible_party>
  <keyword>Postoperative pain</keyword>
  <keyword>Multimodal analgesia</keyword>
  <keyword>Bascom Cleft Lift</keyword>
  <keyword>Day-case.</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</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/NCT02196727
org study id: BPP
nct id: NCT02196727
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate postoperative pain in Bascom Cleft Lift operation
      receiving multimodal analgesia in day-case surgery setting.

      Hypothesis: Multimodal analgesia provides adequate pain relief in patients undergoing Bascom
      Cleft Lift operation.
observational model: Cohort
time perspective: Prospective
measure: Numerical Rating Scale (NRS) pain score (0=no pain, 10= maximum imaginable pain)
time frame: 24 hours postoperatively
measure: Numerical Rating Scale (NRS) pain score (0=no pain, 10= maximum imaginable pain)
time frame: 2 hours, 48 hours and 30 days postoperatively
measure: Nausea
time frame: 2 hours postoperatively
description: Scale (0= non, 1= mild, 2= moderate, 3= severe)
measure: Returning to work
time frame: 30 days
description: Questionnaire: "Yes" or "No"
measure: Returning to leisure activities
time frame: 30 days
description: Questionnaire: "Yes" or "No"
measure: Wound condition
time frame: 30 days
description: Wound inspection for healing problems or infection
measure: Vomiting
time frame: 2 hours postoperatively
description: Scale (0= non, 1= mild, 2= moderate, 3= severe)
arm group label: Patients undergoing Bascom operation
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Hvidovre University Hospital
investigator full name: Saphana Jassim Mohamed
investigator title: Consultant
mesh term: Pain, Postoperative