<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/NCT03267979</url>
  </required_header>
  <id_info>
    <org_study_id>IRBN402014/CHUSTE</org_study_id>
    <secondary_id>CNIL</secondary_id>
    <nct_id>NCT03267979</nct_id>
  </id_info>
  <brief_title>Assessing Pain in the Postoperative Period by Automatically Measuring the Variation Coefficient of Pupillary Diameter: PREVANS Study</brief_title>
  <acronym>PREVANS</acronym>
  <official_title>Assessing Pain in the Postoperative Period by Automatically Measuring the Variation Coefficient of Pupillary Diameter: PREVANS Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Saint Etienne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Saint Etienne</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>
      Different pain assessment methods have been proposed to evaluate analgesic efficacy after&#xD;
      surgical operation. Pain is a subjective phenomenon. Patient did his pain self assessment.&#xD;
      But, cooperation of the patient is limited by cultural differences, language barriers or&#xD;
      residual effect of products used while general anesthesia.&#xD;
&#xD;
      A lot of study were conducted to demonstrate and to quantify the pain after an operation. The&#xD;
      aim will be dose analgesic treatment better without cooperation of the patient.&#xD;
&#xD;
      This sudy concerns patients on the post anesthesia care units one hour after their arrival.&#xD;
      They will have electrocardiogram and video-pupillometer.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Primary objective is to compare Variation Coefficient of Pupillary Diameter (VCPD) obtained&#xD;
      during a light flash and pain assessment realized thanks to Visual Analog Scale (VAS). Too,&#xD;
      Variation Coefficient of Pupillary Diameter (VCPD) with electrocardiogram will be measured to&#xD;
      demonstrate a correlation between the three parameters.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2, 2014</start_date>
  <completion_date type="Actual">March 31, 2015</completion_date>
  <primary_completion_date type="Actual">March 31, 2015</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation between pupillary diameter (PD) and pain assessment</measure>
    <time_frame>1 hour post surgery</time_frame>
    <description>Correlation between pupillary diameter (PD) and pain in the post-operative period.&#xD;
PD will be measured by video-pupillometer. Pain will be measured by Visual Analog Scale (VAS).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation between pupillary diameter (PD) and heart rate</measure>
    <time_frame>1 hour post surgery</time_frame>
    <description>Correlation between pupillary diameter (PD) and heart rate in the post-operative period.&#xD;
Heart rate will be measured by electrocardiogram.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">345</enrollment>
  <condition>Anesthesia, General</condition>
  <arm_group>
    <arm_group_label>Patients have a surgical operation</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients have a surgical operation and have received analgesic treatment. One hour after the end of surgical patients will have electrocardiogram and video-pupillometer.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Video-pupillometer</intervention_name>
    <description>Video-pupillometer will be performed. In this study data will be collected and analyzed.</description>
    <arm_group_label>Patients have a surgical operation</arm_group_label>
    <other_name>Algiscan</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Electrocardiogram</intervention_name>
    <description>Electrocardiogram will be performed. In this study data will be collected and analyzed.</description>
    <arm_group_label>Patients have a surgical operation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Major patients&#xD;
&#xD;
          -  Patients fluent in French&#xD;
&#xD;
          -  Patient admitted on the post anesthesia care units&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  Patients operated for all types of surgery except for heart, intra-cerebral, and&#xD;
             ophthalmologic surgeries&#xD;
&#xD;
          -  Emergency operation&#xD;
&#xD;
          -  Heart rhythm disorders&#xD;
&#xD;
          -  Pacemaker&#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>David CHARIER, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU SAINT-ETIENNE</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU de Saint-Etienne</name>
      <address>
        <city>Saint-Etienne</city>
        <zip>42100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 31, 2017</study_first_posted>
  <last_update_submitted>August 29, 2017</last_update_submitted>
  <last_update_submitted_qc>August 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pain assessment</keyword>
  <keyword>pupillary diameter</keyword>
  <keyword>variation coefficient of pupillary diameter</keyword>
  <keyword>pain self assessment</keyword>
  <keyword>video-pupillometer</keyword>
  <keyword>electrocardiogram</keyword>
  <keyword>analgesic treatment</keyword>
  <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/NCT03267979
org study id: IRBN402014/CHUSTE
secondary id: CNIL
nct id: NCT03267979
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Different pain assessment methods have been proposed to evaluate analgesic efficacy after
      surgical operation. Pain is a subjective phenomenon. Patient did his pain self assessment.
      But, cooperation of the patient is limited by cultural differences, language barriers or
      residual effect of products used while general anesthesia.

      A lot of study were conducted to demonstrate and to quantify the pain after an operation. The
      aim will be dose analgesic treatment better without cooperation of the patient.

      This sudy concerns patients on the post anesthesia care units one hour after their arrival.
      They will have electrocardiogram and video-pupillometer.
Primary objective is to compare Variation Coefficient of Pupillary Diameter (VCPD) obtained
      during a light flash and pain assessment realized thanks to Visual Analog Scale (VAS). Too,
      Variation Coefficient of Pupillary Diameter (VCPD) with electrocardiogram will be measured to
      demonstrate a correlation between the three parameters.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Correlation between pupillary diameter (PD) and pain assessment
time frame: 1 hour post surgery
description: Correlation between pupillary diameter (PD) and pain in the post-operative period.
PD will be measured by video-pupillometer. Pain will be measured by Visual Analog Scale (VAS).
measure: Correlation between pupillary diameter (PD) and heart rate
time frame: 1 hour post surgery
description: Correlation between pupillary diameter (PD) and heart rate in the post-operative period.
Heart rate will be measured by electrocardiogram.
arm group label: Patients have a surgical operation
arm group type: Other
description: Patients have a surgical operation and have received analgesic treatment. One hour after the end of surgical patients will have electrocardiogram and video-pupillometer.
intervention type: Other
intervention name: Video-pupillometer
description: Video-pupillometer will be performed. In this study data will be collected and analyzed.
arm group label: Patients have a surgical operation
other name: Algiscan
intervention type: Other
intervention name: Electrocardiogram
description: Electrocardiogram will be performed. In this study data will be collected and analyzed.
arm group label: Patients have a surgical operation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David CHARIER, MD
role: Principal Investigator
affiliation: CHU SAINT-ETIENNE
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No