<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/NCT01666379</url>
  </required_header>
  <id_info>
    <org_study_id>ForefootFenta vs.2</org_study_id>
    <nct_id>NCT01666379</nct_id>
  </id_info>
  <brief_title>Pain Management After Forefoot Surgery</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Turku University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Turku University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study was to compare the efficacy of transdermal fentanyl to placebo both&#xD;
      administered together with peroral nonsteroidal antiinflammatory drug (NSAID) and paracetamol&#xD;
      in treatment of postoperative pain after hallux valgus or hallux rigidus surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2009</start_date>
  <completion_date type="Actual">November 2010</completion_date>
  <primary_completion_date type="Actual">November 2010</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, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Consumption of rescue opioid</measure>
    <time_frame>on the 1st postoperative day</time_frame>
    <description>Also adverse effects were evaluated but this evaluation was not the first or secondary outcome measure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain on a numerical scale</measure>
    <time_frame>on the 1st postoperative day</time_frame>
    <description>The adverse effects were evaluated but the evaluation was not the first or secondary outcome measure</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>Fentanyl</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fentanyl</intervention_name>
    <arm_group_label>Fentanyl</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  unilateral hallux valgus or hallux rigidus surgery&#xD;
&#xD;
          -  18-75 yrs old&#xD;
&#xD;
          -  ASA I-III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous history of intolerance to the study drug&#xD;
&#xD;
          -  history of alcoholism&#xD;
&#xD;
          -  drug abuse&#xD;
&#xD;
          -  psychological or other emotional problems that are likely to invalidate informed&#xD;
             consent&#xD;
&#xD;
          -  sleep apnoea&#xD;
&#xD;
          -  BMI ≥ 35 kg/m2&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The Department of Anaesthesiology, Intensive Care, Emergency Care and Pain Management of Turku University Hospital</name>
      <address>
        <city>Turku</city>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>July 19, 2012</study_first_submitted>
  <study_first_submitted_qc>August 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <last_update_submitted>August 10, 2012</last_update_submitted>
  <last_update_submitted_qc>August 10, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 16, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Turku University Hospital</investigator_affiliation>
    <investigator_full_name>Riika Merivirta</investigator_full_name>
    <investigator_title>M.D.</investigator_title>
  </responsible_party>
  <keyword>Hallux valgus</keyword>
  <keyword>Forefoot</keyword>
  <keyword>transdermal fentanyl</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/NCT01666379
org study id: ForefootFenta vs.2
nct id: NCT01666379
lead sponsor: 
has dmc: No
The purpose of this study was to compare the efficacy of transdermal fentanyl to placebo both
      administered together with peroral nonsteroidal antiinflammatory drug (NSAID) and paracetamol
      in treatment of postoperative pain after hallux valgus or hallux rigidus surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Consumption of rescue opioid
time frame: on the 1st postoperative day
description: Also adverse effects were evaluated but this evaluation was not the first or secondary outcome measure
measure: Pain on a numerical scale
time frame: on the 1st postoperative day
description: The adverse effects were evaluated but the evaluation was not the first or secondary outcome measure
arm group label: Fentanyl
arm group type: Experimental
arm group label: placebo
arm group type: Placebo Comparator
intervention type: Drug
intervention name: Fentanyl
arm group label: Fentanyl
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
facility: 
country: Finland
responsible party type: Principal Investigator
investigator affiliation: Turku University Hospital
investigator full name: Riika Merivirta
investigator title: M.D.
mesh term: Pain, Postoperative
mesh term: Fentanyl