<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/NCT03281213</url>
  </required_header>
  <id_info>
    <org_study_id>genderthorpain</org_study_id>
    <nct_id>NCT03281213</nct_id>
  </id_info>
  <brief_title>Acute Postthoracotomy Pain - Impact of Gender</brief_title>
  <official_title>No Impact of Gender on Acute Postthoracotomy Pain - a Retrospective Analysis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Graz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Graz</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Adequate analgesia in thoracic surgery is essential to prevent severe postoperative&#xD;
      complications, especially respiratory problems. Current knowledge about gender-related&#xD;
      differences in pain states generally more frequent and intense pain and more demand for&#xD;
      analgesics in women. Results about postsurgical pain in particular are very inconclusive.&#xD;
&#xD;
      The investigators tried to find out if gender has an influence on postthoracotomy pain and&#xD;
      analgesics requirement.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 1, 2010</start_date>
  <completion_date type="Actual">June 1, 2016</completion_date>
  <primary_completion_date type="Actual">December 31, 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analogue Scores</measure>
    <time_frame>first 5 postoperative days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Analgesics requirement</measure>
    <time_frame>first 5 postoperative days</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">346</enrollment>
  <condition>Gender</condition>
  <condition>Postoperative Pain</condition>
  <condition>Thoracotomy</condition>
  <condition>Analgesia</condition>
  <arm_group>
    <arm_group_label>Female</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Male</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Thoracotomy</intervention_name>
    <arm_group_label>Female</arm_group_label>
    <arm_group_label>Male</arm_group_label>
  </intervention>
  <eligibility>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  open lung surgery between July 2010 and December 2014&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  redo-thoracotomy&#xD;
&#xD;
          -  chest wall or rib resection&#xD;
&#xD;
          -  other approach than lateral thoracotomy&#xD;
&#xD;
          -  additional incision at other site (e.g. laparotomy)&#xD;
&#xD;
          -  chest trauma&#xD;
&#xD;
          -  mesothelioma&#xD;
&#xD;
          -  hemofiltration or haemodialysis&#xD;
&#xD;
          -  longer than one day stay at intensive care unit&#xD;
&#xD;
          -  pre-existent chronic pain and/or chronic opioid intake&#xD;
&#xD;
          -  short stay in hospital&#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>Daniel Auinger, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University of Graz</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Freyja-Maria Smolle-Jüttner</last_name>
    <role>Study Director</role>
    <affiliation>Medical University of Graz</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Medical University of Graz, Division of Thoracic and Hyperbaric Surgery</name>
      <address>
        <city>Graz</city>
        <state>Styria</state>
        <zip>8036</zip>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Austria</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>September 12, 2017</last_update_submitted>
  <last_update_submitted_qc>September 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Graz</investigator_affiliation>
    <investigator_full_name>Auinger, Daniel MD</investigator_full_name>
    <investigator_title>Dr. med. univ.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03281213
org study id: genderthorpain
nct id: NCT03281213
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Adequate analgesia in thoracic surgery is essential to prevent severe postoperative
      complications, especially respiratory problems. Current knowledge about gender-related
      differences in pain states generally more frequent and intense pain and more demand for
      analgesics in women. Results about postsurgical pain in particular are very inconclusive.

      The investigators tried to find out if gender has an influence on postthoracotomy pain and
      analgesics requirement.
observational model: Other
time perspective: Retrospective
measure: Visual Analogue Scores
time frame: first 5 postoperative days
measure: Analgesics requirement
time frame: first 5 postoperative days
arm group label: Female
arm group label: Male
intervention type: Other
intervention name: Thoracotomy
arm group label: Female
arm group label: Male
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Daniel Auinger, MD
role: Principal Investigator
affiliation: Medical University of Graz
last name: Freyja-Maria Smolle-Jüttner
role: Study Director
affiliation: Medical University of Graz
facility: 
country: Austria
responsible party type: Principal Investigator
investigator affiliation: Medical University of Graz
investigator full name: Auinger, Daniel MD
investigator title: Dr. med. univ.
mesh term: Pain, Postoperative
sharing ipd: No