<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/NCT01701921</url>
  </required_header>
  <id_info>
    <org_study_id>7/13-07-2011</org_study_id>
    <nct_id>NCT01701921</nct_id>
  </id_info>
  <brief_title>The Effects of Pregabalin on Postoperative Pain After Cardiac Surgery</brief_title>
  <official_title>The Effects of Pregabalin on Acute and Chronic Postoperative Pain After Cardiac Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Larissa University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Larissa University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether pregabalin is effective in the treatment of&#xD;
      acute postoperative pain after cardiac surgery if administered before the surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pregabalin was introduced as an antiepileptic drug with analgesic anti-hyperalgesic and&#xD;
      anxiolytic properties and was also used to treat neuropathic pain. In recent years it has&#xD;
      been used as part of a multimodal management of acute postoperative pain after various types&#xD;
      of surgery. We study the effect of pregabalin administered before cardiac surgery on acute&#xD;
      and chronic postoperative pain. Post CABG syndrome is well known since 1980 and various&#xD;
      analgesic methods have been used from time to time (opioids, regional analgesia,&#xD;
      non-steroidal anti-inflammatory drugs). In our research patients will be divided into three&#xD;
      groups. The control group will receive a placebo capsule before surgery. The second group&#xD;
      will receive 75mg of pregabalin per os before surgery while the third will receive 150mg of&#xD;
      pregabalin. After the surgery all patients will be connected to an intravenous PCA morphine&#xD;
      pump for 48 hours. The postoperative pain will be assessed with the Visual Analogue Scale&#xD;
      (0-10) every day. Total morphine consumption by the patients as well as any other pain&#xD;
      medications administered supplementary will be registered and compared between the different&#xD;
      groups. Remaining postoperative pain will be assessed after 3 months. The results will be&#xD;
      statistically analyzed in order to determine whether there is significant difference in pain&#xD;
      management between the groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2011</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">February 2016</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>opioid consumption and other analgesics after surgery</measure>
    <time_frame>24 hours after surgery</time_frame>
    <description>Patients will be questioned about postoperative pain and opioid consumption will be measured during the first 24 hours after surgery. Other analgesics they may receive will also be recorded.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Remaining surgery related pain and analgesics consumption</measure>
    <time_frame>3 months after surgery</time_frame>
    <description>Patients will be questioned three month after surgery about the presence of post operative pain, whether it affects their quality of life and whether they are receiving pain treatment</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">94</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>Pregabalin 75</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Pregabalin 75mg by mouth one hour before surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pregabalin 150</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pregabalin 150mg by mouth one hour before surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sugar pill</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo : Sugar pill manufactured to mimic pregabalin capsule by mouth one hour before surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Pregabalin 75mg</intervention_name>
    <description>Pregabalin 75mg by mouth one hour before surgery</description>
    <arm_group_label>Pregabalin 75</arm_group_label>
    <other_name>Lyrica</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>pregabalin 150 mg</intervention_name>
    <description>pregabalin 150mg by mouth one hour before surgery</description>
    <arm_group_label>Pregabalin 150</arm_group_label>
    <other_name>Lyrica</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Sugar pill designed to mimic pregabalin capsule, by mouth one hour before surgery</description>
    <arm_group_label>Sugar pill</arm_group_label>
    <other_name>Sugar pill</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients' age 18-85years who are undergoing cardiac surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic pain syndromes&#xD;
&#xD;
          -  Renal failure&#xD;
&#xD;
          -  Age &gt;85&#xD;
&#xD;
          -  Allergy to Pregabalin&#xD;
&#xD;
          -  Patients already taking pregabalin&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Aikaterini A Bouzia, Medicine</last_name>
    <role>Principal Investigator</role>
    <affiliation>PhD candidate, School of Medicine, Univercity of Larissa</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Georgios Vretzakis, Medicine</last_name>
    <role>Study Director</role>
    <affiliation>Associate Professor of Anaesthesiology, Schooll of Medicine, University of Larissa</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Univercity Hospital of Larissa</name>
      <address>
        <city>Larissa</city>
        <state>Thessaly</state>
        <zip>41110</zip>
        <country>Greece</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Greece</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>October 3, 2012</study_first_submitted>
  <study_first_submitted_qc>October 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 5, 2012</study_first_posted>
  <last_update_submitted>September 8, 2016</last_update_submitted>
  <last_update_submitted_qc>September 8, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 12, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Larissa University Hospital</investigator_affiliation>
    <investigator_full_name>Aikaterini Bouzia</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>cardiac surgery</keyword>
  <keyword>pregabalin</keyword>
  <keyword>postoperative pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pregabalin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT01701921
org study id: 7/13-07-2011
nct id: NCT01701921
lead sponsor: 
has dmc: No
The purpose of this study is to determine whether pregabalin is effective in the treatment of
      acute postoperative pain after cardiac surgery if administered before the surgery.
Pregabalin was introduced as an antiepileptic drug with analgesic anti-hyperalgesic and
      anxiolytic properties and was also used to treat neuropathic pain. In recent years it has
      been used as part of a multimodal management of acute postoperative pain after various types
      of surgery. We study the effect of pregabalin administered before cardiac surgery on acute
      and chronic postoperative pain. Post CABG syndrome is well known since 1980 and various
      analgesic methods have been used from time to time (opioids, regional analgesia,
      non-steroidal anti-inflammatory drugs). In our research patients will be divided into three
      groups. The control group will receive a placebo capsule before surgery. The second group
      will receive 75mg of pregabalin per os before surgery while the third will receive 150mg of
      pregabalin. After the surgery all patients will be connected to an intravenous PCA morphine
      pump for 48 hours. The postoperative pain will be assessed with the Visual Analogue Scale
      (0-10) every day. Total morphine consumption by the patients as well as any other pain
      medications administered supplementary will be registered and compared between the different
      groups. Remaining postoperative pain will be assessed after 3 months. The results will be
      statistically analyzed in order to determine whether there is significant difference in pain
      management between the groups.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: opioid consumption and other analgesics after surgery
time frame: 24 hours after surgery
description: Patients will be questioned about postoperative pain and opioid consumption will be measured during the first 24 hours after surgery. Other analgesics they may receive will also be recorded.
measure: Remaining surgery related pain and analgesics consumption
time frame: 3 months after surgery
description: Patients will be questioned three month after surgery about the presence of post operative pain, whether it affects their quality of life and whether they are receiving pain treatment
arm group label: Pregabalin 75
arm group type: Experimental
description: Pregabalin 75mg by mouth one hour before surgery
arm group label: Pregabalin 150
arm group type: Active Comparator
description: Pregabalin 150mg by mouth one hour before surgery
arm group label: Sugar pill
arm group type: Placebo Comparator
description: Placebo : Sugar pill manufactured to mimic pregabalin capsule by mouth one hour before surgery
intervention type: Drug
intervention name: Pregabalin 75mg
description: Pregabalin 75mg by mouth one hour before surgery
arm group label: Pregabalin 75
other name: Lyrica
intervention type: Drug
intervention name: pregabalin 150 mg
description: pregabalin 150mg by mouth one hour before surgery
arm group label: Pregabalin 150
other name: Lyrica
intervention type: Drug
intervention name: Placebo
description: Sugar pill designed to mimic pregabalin capsule, by mouth one hour before surgery
arm group label: Sugar pill
other name: Sugar pill
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Aikaterini A Bouzia, Medicine
role: Principal Investigator
affiliation: PhD candidate, School of Medicine, Univercity of Larissa
last name: Georgios Vretzakis, Medicine
role: Study Director
affiliation: Associate Professor of Anaesthesiology, Schooll of Medicine, University of Larissa
facility: 
country: Greece
responsible party type: Principal Investigator
investigator affiliation: Larissa University Hospital
investigator full name: Aikaterini Bouzia
investigator title: MD
mesh term: Pain, Postoperative
mesh term: Pregabalin
sharing ipd: Undecided