<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/NCT02237963</url>
  </required_header>
  <id_info>
    <org_study_id>2013/50</org_study_id>
    <secondary_id>2013- A01641-44</secondary_id>
    <nct_id>NCT02237963</nct_id>
  </id_info>
  <brief_title>Influence of the Surgical Approach on the Development of a Chronic Pain After Thoracic Surgery</brief_title>
  <acronym>IncisionPain</acronym>
  <official_title>Influence of the Surgical Approach on the Development of a Chronic Pain After Thoracic Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hopital Foch</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hopital Foch</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The prevalence of chronic pain after a thoracotomy is around 48 %. This research focuses on&#xD;
      the surgical approach. The posterolateral approach is compared to the axillary approach&#xD;
      especially in term of development of a chronic pain.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>4 Months</target_duration>
  <primary_outcome>
    <measure>Chronic pain</measure>
    <time_frame>4 months</time_frame>
    <description>Prevalence of pain 4 months after surgery. Pain is evaluated using a numeric scale ranging from 0 (no pain) to 10 (maximal pain)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Early postoperative pain</measure>
    <time_frame>7 days</time_frame>
    <description>Evolution of pain from postoperative day 1 to postoperative day 6 (&quot;pain trajectory&quot;) Prevalence of pain 5 to 7 days after surgery. Pain is evaluated using a numeric scale ranging from 0 (no pain) to 10 (maximal pain).&#xD;
Clinical examination to detect modification of skin sensibility</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Characteristics of chronic pain</measure>
    <time_frame>4 months</time_frame>
    <description>Characteristics are notably:&#xD;
its localization and intensity,&#xD;
its neuropathic origin,&#xD;
its impact on daily life,&#xD;
required analgesic treatment,&#xD;
need for a specific pain consultation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life</measure>
    <time_frame>4 months</time_frame>
    <description>Specific questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Catastrophism</measure>
    <time_frame>4 months</time_frame>
    <description>Score of Sullivan</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>4 months</time_frame>
    <description>Stai trait</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preventive role of epidural analgesia</measure>
    <time_frame>4 months</time_frame>
    <description>Proportion of patients with chronic pain in each cohort who had had a postoperative thoracic epidural analgesia</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">209</enrollment>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>Posterolateral thoracotomy</arm_group_label>
    <description>Surgeons perform a posterolateral thoracotomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Axillary thoracotomy</arm_group_label>
    <description>Surgeons perform an axillary thoracotomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Posterolateral thoracotomy</intervention_name>
    <arm_group_label>Posterolateral thoracotomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Axillary thoracotomy</intervention_name>
    <arm_group_label>Axillary thoracotomy</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients undergoing thoracic surgery by posterolateral or axillary thoracotomy, having no&#xD;
        exclusion criteria for the study,&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients undergoing thoracic surgery intervention by posterolateral or axillary&#xD;
             thoracotomy, having no exclusion criteria for the study,&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  planned surgery by thoracoscopy or extended surgery,&#xD;
&#xD;
          -  mental disability,&#xD;
&#xD;
          -  vulnerable person within the meaning of French law,&#xD;
&#xD;
          -  inability to communicate by phone,&#xD;
&#xD;
          -  poor understanding of French.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mireille Michel-Cherqui, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpital Foch</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hopital Foch</name>
      <address>
        <city>Suresnes</city>
        <zip>92151</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Ringsted TK, Wildgaard K, Kreiner S, Kehlet H. Pain-related impairment of daily activities after thoracic surgery: a questionnaire validation. Clin J Pain. 2013 Sep;29(9):791-9. doi: 10.1097/AJP.0b013e318278d4e2.</citation>
    <PMID>23370071</PMID>
  </reference>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>September 9, 2014</study_first_submitted>
  <study_first_submitted_qc>September 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>October 28, 2016</last_update_submitted>
  <last_update_submitted_qc>October 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 31, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic Pain</mesh_term>
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_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/NCT02237963
org study id: 2013/50
secondary id: 2013- A01641-44
nct id: NCT02237963
lead sponsor: 
has dmc: No
The prevalence of chronic pain after a thoracotomy is around 48 %. This research focuses on
      the surgical approach. The posterolateral approach is compared to the axillary approach
      especially in term of development of a chronic pain.
observational model: Cohort
time perspective: Prospective
measure: Chronic pain
time frame: 4 months
description: Prevalence of pain 4 months after surgery. Pain is evaluated using a numeric scale ranging from 0 (no pain) to 10 (maximal pain)
measure: Early postoperative pain
time frame: 7 days
description: Evolution of pain from postoperative day 1 to postoperative day 6 ("pain trajectory") Prevalence of pain 5 to 7 days after surgery. Pain is evaluated using a numeric scale ranging from 0 (no pain) to 10 (maximal pain).
Clinical examination to detect modification of skin sensibility
measure: Characteristics of chronic pain
time frame: 4 months
description: Characteristics are notably:
its localization and intensity,
its neuropathic origin,
its impact on daily life,
required analgesic treatment,
need for a specific pain consultation
measure: Quality of life
time frame: 4 months
description: Specific questionnaire
measure: Catastrophism
time frame: 4 months
description: Score of Sullivan
measure: Anxiety
time frame: 4 months
description: Stai trait
measure: Preventive role of epidural analgesia
time frame: 4 months
description: Proportion of patients with chronic pain in each cohort who had had a postoperative thoracic epidural analgesia
arm group label: Posterolateral thoracotomy
description: Surgeons perform a posterolateral thoracotomy
arm group label: Axillary thoracotomy
description: Surgeons perform an axillary thoracotomy
intervention type: Procedure
intervention name: Posterolateral thoracotomy
arm group label: Posterolateral thoracotomy
intervention type: Procedure
intervention name: Axillary thoracotomy
arm group label: Axillary thoracotomy
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mireille Michel-Cherqui, MD
role: Principal Investigator
affiliation: Hôpital Foch
facility: 
country: France
citation: Ringsted TK, Wildgaard K, Kreiner S, Kehlet H. Pain-related impairment of daily activities after thoracic surgery: a questionnaire validation. Clin J Pain. 2013 Sep;29(9):791-9. doi: 10.1097/AJP.0b013e318278d4e2.
PMID: 23370071
responsible party type: Sponsor
mesh term: Chronic Pain
mesh term: Pain, Postoperative