<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/NCT01726530</url>
  </required_header>
  <id_info>
    <org_study_id>HE541094</org_study_id>
    <nct_id>NCT01726530</nct_id>
  </id_info>
  <brief_title>Transdermal Fentanyl Patch for Postoperative Analgesia After Abdominal Surgery: a Randomized Placebo-controlled Trial</brief_title>
  <official_title>Transdermal Fentanyl Patch for Postoperative Analgesia After Abdominal Surgery: a Randomized Placebo-controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Khon Kaen University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Khon Kaen University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Abdominal surgery causes severe postoperative pain. Multi-modal pain therapy is usually&#xD;
      applied but there is no perfect choice. It depends on physician's skill and situation. The&#xD;
      best regimen is patient-controlled analgesia, but it requires an expensive equipment.&#xD;
      Transdermal fentanyl patch, usually used in chronic pain relief, can steadily release&#xD;
      fentanyl into blood stream for 72 hours, but it has slow onset of 12 hours.&#xD;
&#xD;
      Hypothesis: If Transdermal fentanyl patch is applied 10-12 hours before surgery, it may&#xD;
      provide good analgesia for 72 hours.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>June 2011</start_date>
  <completion_date type="Actual">August 2012</completion_date>
  <primary_completion_date type="Actual">October 2011</primary_completion_date>
  <phase>N/A</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>morphine consumption</measure>
    <time_frame>24 hours</time_frame>
    <description>Compare the cumulative morphine consumption during 24 hours postoperative of both study and control groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>morphine consumption</measure>
    <time_frame>48 and 72 hours</time_frame>
    <description>Compare the cumulative morphine consumption during 48 and 72 hours postoperative of both study and control groups.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>side effects</measure>
    <time_frame>72 hours</time_frame>
    <description>Compare the side effects, i.e.nausea, vomiting, itching, respiratory depression during 72 hours postoperative of both study and control groups.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Postoperative Pain Relief</condition>
  <arm_group>
    <arm_group_label>Transdermal fentanyl patch</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Transdermal fentanyl patch, 50 mcg/hour, was attached to the patient's chest wall at 10 pm the day before surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo patch was attached to the patient's chest wall at 10 pm the day before surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>transdermal fentanyl patch (50 mcg/hour)</intervention_name>
    <arm_group_label>Transdermal fentanyl patch</arm_group_label>
    <other_name>Duragesic</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age =&gt;18 years&#xD;
&#xD;
          -  scheduled for abdominal surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ASA class &gt; 3&#xD;
&#xD;
          -  Known allergy to fentanyl or morphine&#xD;
&#xD;
          -  History of substance or alcohol abuse, and tolerance or dependence on opioids&#xD;
&#xD;
          -  Combined epidural block&#xD;
&#xD;
          -  Can't use PCA, abnormal renal / liver function&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Thepakorn Sathitkarnmanee, MD.</last_name>
    <role>Study Chair</role>
    <affiliation>Khon Kaen University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Srinagarind hospital</name>
      <address>
        <city>Khon Kaen</city>
        <zip>40002</zip>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Thailand</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 10, 2012</study_first_submitted>
  <study_first_submitted_qc>November 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 15, 2012</study_first_posted>
  <last_update_submitted>November 14, 2012</last_update_submitted>
  <last_update_submitted_qc>November 14, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 15, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Khon Kaen University</investigator_affiliation>
    <investigator_full_name>Thepakorn Sathitkarnmanee</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>transdermal fentanyl patch, 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>Fentanyl</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/NCT01726530
org study id: HE541094
nct id: NCT01726530
lead sponsor: 
has dmc: No
Abdominal surgery causes severe postoperative pain. Multi-modal pain therapy is usually
      applied but there is no perfect choice. It depends on physician's skill and situation. The
      best regimen is patient-controlled analgesia, but it requires an expensive equipment.
      Transdermal fentanyl patch, usually used in chronic pain relief, can steadily release
      fentanyl into blood stream for 72 hours, but it has slow onset of 12 hours.

      Hypothesis: If Transdermal fentanyl patch is applied 10-12 hours before surgery, it may
      provide good analgesia for 72 hours.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: morphine consumption
time frame: 24 hours
description: Compare the cumulative morphine consumption during 24 hours postoperative of both study and control groups.
measure: morphine consumption
time frame: 48 and 72 hours
description: Compare the cumulative morphine consumption during 48 and 72 hours postoperative of both study and control groups.
measure: side effects
time frame: 72 hours
description: Compare the side effects, i.e.nausea, vomiting, itching, respiratory depression during 72 hours postoperative of both study and control groups.
arm group label: Transdermal fentanyl patch
arm group type: Active Comparator
description: Transdermal fentanyl patch, 50 mcg/hour, was attached to the patient's chest wall at 10 pm the day before surgery
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo patch was attached to the patient's chest wall at 10 pm the day before surgery
intervention type: Drug
intervention name: transdermal fentanyl patch (50 mcg/hour)
arm group label: Transdermal fentanyl patch
other name: Duragesic
intervention type: Drug
intervention name: Placebo
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Thepakorn Sathitkarnmanee, MD.
role: Study Chair
affiliation: Khon Kaen University
facility: 
country: Thailand
responsible party type: Principal Investigator
investigator affiliation: Khon Kaen University
investigator full name: Thepakorn Sathitkarnmanee
investigator title: Associate Professor
mesh term: Pain, Postoperative
mesh term: Fentanyl