<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/NCT01726205</url>
  </required_header>
  <id_info>
    <org_study_id>PRGCWI1</org_study_id>
    <nct_id>NCT01726205</nct_id>
  </id_info>
  <brief_title>Perioperative Pregabalin and Continuous Wound Infusion for Pain Control Following Thoracotomy</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Attikon Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Attikon Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the efficacy of pregabalin or pregabalin and&#xD;
      continuous wound infusion versus placebo for analgesia following thoracotomy&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2008</start_date>
  <completion_date type="Actual">May 2012</completion_date>
  <primary_completion_date type="Actual">May 2012</primary_completion_date>
  <phase>Phase 4</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain control</measure>
    <time_frame>5 days postoperatively</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>morphine consumption</measure>
    <time_frame>3 days postoperatively</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>side effects, pain at 1 and 3 months, incidence of neuropathic pain</measure>
    <time_frame>3 months</time_frame>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Post-thoracotomy Pain</condition>
  <arm_group>
    <arm_group_label>pregabalin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>perioperative pregabalin starting the evening before surgery, and for five days postoperatively</description>
  </arm_group>
  <arm_group>
    <arm_group_label>pregabalin and continuous wound infusion</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pregabalin as previous group and continuous infusion of ropivacaine 0.2% via a wound catheter</description>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo drug and normal saline infusion</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pregabalin and normal saline infusion, PRG</intervention_name>
    <arm_group_label>pregabalin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pregabalin and ropivacaine 02% infusion</intervention_name>
    <arm_group_label>pregabalin and continuous wound infusion</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo drug, normal saline infusion</intervention_name>
    <arm_group_label>placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients scheduled for a thoracotomy,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &gt;70 years&#xD;
&#xD;
          -  BMI &gt; 30&#xD;
&#xD;
          -  preoperative Hb &lt; 10 mg/dL&#xD;
&#xD;
          -  preexistent chronic pain&#xD;
&#xD;
          -  neurologic disease&#xD;
&#xD;
          -  chronic assumption of alcohol&#xD;
&#xD;
          -  treatment with analgesics, anxiolytics, sedatives, antidepressants, or calcium channel&#xD;
             inhibitors&#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>Tatiana Sidiropoulou</last_name>
    <role>Principal Investigator</role>
    <affiliation>Attikon Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eyaggelos Giavasopoulos</last_name>
    <role>Principal Investigator</role>
    <affiliation>Attikon Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Attikon Hospital</name>
      <address>
        <city>Athens</city>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 9, 2012</study_first_submitted>
  <study_first_submitted_qc>November 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 14, 2012</study_first_posted>
  <last_update_submitted>November 9, 2012</last_update_submitted>
  <last_update_submitted_qc>November 9, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 14, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Attikon Hospital</investigator_affiliation>
    <investigator_full_name>Sidiropoulou Tatiana</investigator_full_name>
    <investigator_title>Lecturer in Anesthesiology, University of Athens</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pregabalin</mesh_term>
    <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/NCT01726205
org study id: PRGCWI1
nct id: NCT01726205
lead sponsor: 
has dmc: No
The purpose of this study is to assess the efficacy of pregabalin or pregabalin and
      continuous wound infusion versus placebo for analgesia following thoracotomy
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Pain control
time frame: 5 days postoperatively
measure: morphine consumption
time frame: 3 days postoperatively
measure: side effects, pain at 1 and 3 months, incidence of neuropathic pain
time frame: 3 months
arm group label: pregabalin
arm group type: Active Comparator
description: perioperative pregabalin starting the evening before surgery, and for five days postoperatively
arm group label: pregabalin and continuous wound infusion
arm group type: Active Comparator
description: Pregabalin as previous group and continuous infusion of ropivacaine 0.2% via a wound catheter
arm group label: placebo
arm group type: Placebo Comparator
description: Placebo drug and normal saline infusion
intervention type: Drug
intervention name: Pregabalin and normal saline infusion, PRG
arm group label: pregabalin
intervention type: Drug
intervention name: Pregabalin and ropivacaine 02% infusion
arm group label: pregabalin and continuous wound infusion
intervention type: Drug
intervention name: Placebo drug, normal saline infusion
arm group label: placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Tatiana Sidiropoulou
role: Principal Investigator
affiliation: Attikon Hospital
last name: Eyaggelos Giavasopoulos
role: Principal Investigator
affiliation: Attikon Hospital
facility: 
country: Greece
responsible party type: Principal Investigator
investigator affiliation: Attikon Hospital
investigator full name: Sidiropoulou Tatiana
investigator title: Lecturer in Anesthesiology, University of Athens
mesh term: Pregabalin
mesh term: Ropivacaine