<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/NCT04415242</url>
  </required_header>
  <id_info>
    <org_study_id>2020-3430, 21919</org_study_id>
    <nct_id>NCT04415242</nct_id>
  </id_info>
  <brief_title>IMPACT OF OPERATIVE POSITIONING ON THE DEVELOPMENT OF SHOULDER PAIN AFTER PULMONARY LOBECTOMY BY VATS</brief_title>
  <acronym>POVA</acronym>
  <official_title>IMPACT OF OPERATIVE POSITIONING ON THE DEVELOPMENT OF SHOULDER PAIN AFTER PULMONARY LOBECTOMY BY VATS</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut universitaire de cardiologie et de pneumologie de Québec, University Laval</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>
      The investigators want to be able to show a 66% decrease in the incidence of shoulder pain in&#xD;
      the &quot;support&quot; group compared to the &quot;suspension&quot; group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The position currently used in cases of pulmonary lobectomies by videothoracoscopy is an&#xD;
      extension associated with an abduction of the shoulder on the side operated by suspension of&#xD;
      the thoracic limb in a trampoline-type arm support with an angulation of more than 90 ° of&#xD;
      the shoulder in the saggital and frontal planes.&#xD;
&#xD;
      The investigators wish to prospectively and randomly compare this position currently used in&#xD;
      the thoracic surgery service of the IUCPQ with a 2nd position which seems less restrictive&#xD;
      for all the joints of the shoulder joint complex in which the patient's arm rests on a&#xD;
      support placed in front of the patient's face. It follows from this position of the joint&#xD;
      degrees less than or equal to 90 ° in all planes. This new position is not experimental, but&#xD;
      not normally used in thoracic surgery at the IUCPQ.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 18, 2020</start_date>
  <completion_date type="Anticipated">March 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2020</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>Prevention</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>post thoracoscopy shoulder pain measured on the Visual Pain Scale</measure>
    <time_frame>from the recovery unit to post-operative day 2</time_frame>
    <description>postoperative shoulder pain measured on the Visual Pain Scale, its precise location on the patient's body will also be assessed</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">134</enrollment>
  <condition>Post-thoracotomy Pain Syndrome</condition>
  <arm_group>
    <arm_group_label>suspension group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Arm on the side operated at 90 ° abduction, 90 ° anti-drive, resting on an arm support.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>supported group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arm on the operated side at 0 ° abduction, 90 ° anti-pulsation, resting on an adjustable support arm support located opposite the patient's head.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>positioning</intervention_name>
    <description>different positioning prior surgery</description>
    <arm_group_label>supported group</arm_group_label>
    <arm_group_label>suspension group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any patient in whom the management of a bronchopulmonary cancer, or his strong&#xD;
             suspicion, justifies a bilobectomy, a lobectomy or a segmentectomy by&#xD;
             videothoracoscopy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  surgery extended to the chest wall, including extra-pleural resections,&#xD;
&#xD;
               -  Pleurectomy,&#xD;
&#xD;
               -  Chronic pain patient suffering from chronic pain preoperatively,&#xD;
&#xD;
               -  Fibromyalgia patient,&#xD;
&#xD;
               -  Chronic taking of analgesic or anti-inflammatory medications during the&#xD;
                  preoperative period, namely taking at least daily for more than 4 weeks,&#xD;
&#xD;
               -  Patient with a history of orthopedic surgery of the upper limb ipsilateral to the&#xD;
                  surgery,&#xD;
&#xD;
               -  Patient with mechanical limitation of the joint range of the upper limb&#xD;
                  ipsilateral to surgery,&#xD;
&#xD;
               -  Non-French speaking patient,&#xD;
&#xD;
               -  Pregnant woman,&#xD;
&#xD;
               -  Patient under 18-year-old,&#xD;
&#xD;
               -  Patient whose BMI is greater than or equal to 35 kg / m2&#xD;
&#xD;
               -  Glomerular filtration rate less than &lt;50 ml / min&#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_contact>
    <last_name>Geraud Galvaing, MD, MSc</last_name>
    <phone>+14186564945</phone>
    <email>geraud.galvaing@clermont.unicancer.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Anne Sophie Laliberté, MD</last_name>
    <phone>+14186564945</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Institut Universitaire de Cardiologie et de pneumologie de Québec</name>
      <address>
        <city>Québec</city>
        <state>Quebec</state>
        <zip>G1v4G5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Geraud Galvaing, MD, MSc</last_name>
      <phone>+14156564945</phone>
      <email>geraud.galvaing@clermont.unicancer.fr</email>
    </contact>
    <contact_backup>
      <last_name>Anne Sophie Laliberté, MD</last_name>
      <phone>+14186564945</phone>
    </contact_backup>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Ip HY, Abrishami A, Peng PW, Wong J, Chung F. Predictors of postoperative pain and analgesic consumption: a qualitative systematic review. Anesthesiology. 2009 Sep;111(3):657-77. doi: 10.1097/ALN.0b013e3181aae87a.</citation>
    <PMID>19672167</PMID>
  </reference>
  <reference>
    <citation>Barak M, Ziser A, Katz Y. Thoracic epidural local anesthetics are ineffective in alleviating post-thoracotomy ipsilateral shoulder pain. J Cardiothorac Vasc Anesth. 2004 Aug;18(4):458-60. doi: 10.1053/j.jvca.2004.05.025.</citation>
    <PMID>15365928</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>July 13, 2020</last_update_submitted>
  <last_update_submitted_qc>July 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec</investigator_affiliation>
    <investigator_full_name>Geraud Galvaing</investigator_full_name>
    <investigator_title>MD, MSc</investigator_title>
  </responsible_party>
  <keyword>VATS</keyword>
  <keyword>shoulder pain</keyword>
  <keyword>pulmonary resection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shoulder Pain</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/NCT04415242
org study id: 2020-3430, 21919
nct id: NCT04415242
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators want to be able to show a 66% decrease in the incidence of shoulder pain in
      the "support" group compared to the "suspension" group.
The position currently used in cases of pulmonary lobectomies by videothoracoscopy is an
      extension associated with an abduction of the shoulder on the side operated by suspension of
      the thoracic limb in a trampoline-type arm support with an angulation of more than 90 ° of
      the shoulder in the saggital and frontal planes.

      The investigators wish to prospectively and randomly compare this position currently used in
      the thoracic surgery service of the IUCPQ with a 2nd position which seems less restrictive
      for all the joints of the shoulder joint complex in which the patient's arm rests on a
      support placed in front of the patient's face. It follows from this position of the joint
      degrees less than or equal to 90 ° in all planes. This new position is not experimental, but
      not normally used in thoracic surgery at the IUCPQ.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Participant)
measure: post thoracoscopy shoulder pain measured on the Visual Pain Scale
time frame: from the recovery unit to post-operative day 2
description: postoperative shoulder pain measured on the Visual Pain Scale, its precise location on the patient's body will also be assessed
arm group label: suspension group
arm group type: Active Comparator
description: Arm on the side operated at 90 ° abduction, 90 ° anti-drive, resting on an arm support.
arm group label: supported group
arm group type: Experimental
description: Arm on the operated side at 0 ° abduction, 90 ° anti-pulsation, resting on an adjustable support arm support located opposite the patient's head.
intervention type: Other
intervention name: positioning
description: different positioning prior surgery
arm group label: supported group
arm group label: suspension group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Geraud Galvaing, MD, MSc
phone: +14186564945
email: geraud.galvaing@clermont.unicancer.fr
last name: Anne Sophie Laliberté, MD
phone: +14186564945
facility: 
status: Recruiting
contact: 
contact backup: 
country: Canada
citation: Ip HY, Abrishami A, Peng PW, Wong J, Chung F. Predictors of postoperative pain and analgesic consumption: a qualitative systematic review. Anesthesiology. 2009 Sep;111(3):657-77. doi: 10.1097/ALN.0b013e3181aae87a.
PMID: 19672167
citation: Barak M, Ziser A, Katz Y. Thoracic epidural local anesthetics are ineffective in alleviating post-thoracotomy ipsilateral shoulder pain. J Cardiothorac Vasc Anesth. 2004 Aug;18(4):458-60. doi: 10.1053/j.jvca.2004.05.025.
PMID: 15365928
responsible party type: Principal Investigator
investigator affiliation: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec
investigator full name: Geraud Galvaing
investigator title: MD, MSc
mesh term: Shoulder Pain
sharing ipd: No