<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/NCT01700491</url>
  </required_header>
  <id_info>
    <org_study_id>B2012:038</org_study_id>
    <nct_id>NCT01700491</nct_id>
  </id_info>
  <brief_title>Pilot Study: Paravertebral Analgesia vs Epidural Analgesia After Thoracotomy</brief_title>
  <acronym>ParaEpi</acronym>
  <official_title>Pilot Study: A Non-Inferiority Trial of the Analgesic Effect of Paravertebral Analgesia to Epidural Analgesia for the Management of Post-Operative Pain After Thoracotomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Manitoba</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Manitoba</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Paravertebral analgesia is non-inferior to epidural analgesia for pain control and superior&#xD;
      to epidural analgesia in terms of the main complication of hypotension.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is some evidence that paravertebral analgesia is similar to epidural analgesia in&#xD;
      efficacy but superior in maintenance of blood pressure. This is a double blind, randomized&#xD;
      control trial comparing paravertebral catheters to epidural catheters for the management of&#xD;
      post thoracotomy analgesia. Both groups will undergo placement of a pre-induction epidural&#xD;
      catheter as well as a surgically placed paravertebral catheter. Patients will also receive&#xD;
      PCA morphine. The primary outcome will be daily morphine use measured in milligrams. The&#xD;
      co-primary outcome will be time spent with a systolic blood pressure below 90mmHg. Outcomes&#xD;
      will be measured during the first five postoperative days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Difficulty in recruiting and maintenance of blinding necessary for the trial&#xD;
  </why_stopped>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">November 2013</completion_date>
  <primary_completion_date type="Actual">November 2013</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Analgesic Effect</measure>
    <time_frame>At postoperative day 5</time_frame>
    <description>Total cumulative dose of morphine equivalent narcotics.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hypotension</measure>
    <time_frame>At postoperative day 5</time_frame>
    <description>Cumulative time in which the systolic blood pressure is below 90mmHg.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">21</enrollment>
  <condition>Hypotension</condition>
  <arm_group>
    <arm_group_label>Epidural Catheter 0.2% ropivacaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive an infusion of 0.2% ropivacaine at a range of 0-10 mL/hr through an epidural catheter. They will also receive an infusion of saline at a rate of 0-10 mL/hr through a paravertebral catheter.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Paravertebral Catheter 0.4% ropivacaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients will receive an infusion of 0.4% ropivacaine at a range of 0-10mL/hr through a paravertebral catheter. They will also receive an infusion of saline at a range of 0-10mL/hr through an epidural catheter.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Epidural Catheter 0.2% ropivacaine</intervention_name>
    <description>0.2% ropivacaine into epidural space and saline into paravertebral space</description>
    <arm_group_label>Epidural Catheter 0.2% ropivacaine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Paravertebral Catheter 0.4% ropivacaine</intervention_name>
    <description>0.4% ropivacaine into paravertebral space and saline into the epidural space</description>
    <arm_group_label>Paravertebral Catheter 0.4% ropivacaine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Open thoracotomy&#xD;
&#xD;
          -  Age &gt; 18 yo&#xD;
&#xD;
          -  Able to use a patient controlled analgesia device&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous thoracotomy&#xD;
&#xD;
          -  Previous spine surgery&#xD;
&#xD;
          -  Chronic pain condition&#xD;
&#xD;
          -  Ongoing narcotic use&#xD;
&#xD;
          -  Prior narcotic abuse&#xD;
&#xD;
          -  Active chest infection&#xD;
&#xD;
          -  Chest trauma&#xD;
&#xD;
          -  Anticoagulation&#xD;
&#xD;
          -  Other contraindication to epidural catheter placement&#xD;
&#xD;
          -  Allergy to local anesthetic or narcotic&#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>Sadeesh Srinathan, MD, FRCS C-Th, FRCS(C)</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Manitoba</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Stephen Kowalski, MD, FRCP</last_name>
    <role>Study Chair</role>
    <affiliation>University of Manitoba</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rob Brown, MD, FRCP</last_name>
    <role>Study Director</role>
    <affiliation>University of Manitoba</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Purnima Rao, MD</last_name>
    <role>Study Director</role>
    <affiliation>University of Manitoba</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Health Sciences Centre</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3A 1R9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Health Sciences Centre</name>
      <address>
        <city>Winnipeg</city>
        <state>Manitoba</state>
        <zip>R3A1R9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>December 2015</verification_date>
  <study_first_submitted>September 27, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>December 11, 2015</last_update_submitted>
  <last_update_submitted_qc>December 11, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 15, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Manitoba</investigator_affiliation>
    <investigator_full_name>Sadeesh Srinathan, MD</investigator_full_name>
    <investigator_title>Assistant Professor- Department of Thoracic Surgery</investigator_title>
  </responsible_party>
  <keyword>Paravertebral Catheter</keyword>
  <keyword>Epidural Catheter</keyword>
  <keyword>Analgesia</keyword>
  <keyword>Hypotension</keyword>
  <keyword>Analgesia,Epidural</keyword>
  <keyword>Analgesia,Paravertebral</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypotension</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/NCT01700491
org study id: B2012:038
nct id: NCT01700491
lead sponsor: 
has dmc: No
Paravertebral analgesia is non-inferior to epidural analgesia for pain control and superior
      to epidural analgesia in terms of the main complication of hypotension.
There is some evidence that paravertebral analgesia is similar to epidural analgesia in
      efficacy but superior in maintenance of blood pressure. This is a double blind, randomized
      control trial comparing paravertebral catheters to epidural catheters for the management of
      post thoracotomy analgesia. Both groups will undergo placement of a pre-induction epidural
      catheter as well as a surgically placed paravertebral catheter. Patients will also receive
      PCA morphine. The primary outcome will be daily morphine use measured in milligrams. The
      co-primary outcome will be time spent with a systolic blood pressure below 90mmHg. Outcomes
      will be measured during the first five postoperative days.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Analgesic Effect
time frame: At postoperative day 5
description: Total cumulative dose of morphine equivalent narcotics.
measure: Hypotension
time frame: At postoperative day 5
description: Cumulative time in which the systolic blood pressure is below 90mmHg.
arm group label: Epidural Catheter 0.2% ropivacaine
arm group type: Active Comparator
description: Patients will receive an infusion of 0.2% ropivacaine at a range of 0-10 mL/hr through an epidural catheter. They will also receive an infusion of saline at a rate of 0-10 mL/hr through a paravertebral catheter.
arm group label: Paravertebral Catheter 0.4% ropivacaine
arm group type: Active Comparator
description: Patients will receive an infusion of 0.4% ropivacaine at a range of 0-10mL/hr through a paravertebral catheter. They will also receive an infusion of saline at a range of 0-10mL/hr through an epidural catheter.
intervention type: Drug
intervention name: Epidural Catheter 0.2% ropivacaine
description: 0.2% ropivacaine into epidural space and saline into paravertebral space
arm group label: Epidural Catheter 0.2% ropivacaine
intervention type: Drug
intervention name: Paravertebral Catheter 0.4% ropivacaine
description: 0.4% ropivacaine into paravertebral space and saline into the epidural space
arm group label: Paravertebral Catheter 0.4% ropivacaine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sadeesh Srinathan, MD, FRCS C-Th, FRCS(C)
role: Principal Investigator
affiliation: University of Manitoba
last name: Stephen Kowalski, MD, FRCP
role: Study Chair
affiliation: University of Manitoba
last name: Rob Brown, MD, FRCP
role: Study Director
affiliation: University of Manitoba
last name: Purnima Rao, MD
role: Study Director
affiliation: University of Manitoba
facility: 
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: University of Manitoba
investigator full name: Sadeesh Srinathan, MD
investigator title: Assistant Professor- Department of Thoracic Surgery
mesh term: Hypotension
mesh term: Ropivacaine