<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/NCT03832920</url>
  </required_header>
  <id_info>
    <org_study_id>2019-A00121-56</org_study_id>
    <nct_id>NCT03832920</nct_id>
  </id_info>
  <brief_title>Analgesia Nociception Index (ANI) After Unilateral Radical Mastectomy as an Evaluation of Paravertebral Block Failure</brief_title>
  <acronym>ANIBPV</acronym>
  <official_title>Analgesia Nociception Index (ANI) After Unilateral Radical Mastectomy as an Evaluation of Paravertebral Block Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Institut de Cancérologie de Lorraine</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Institut de Cancérologie de Lorraine</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>
      Paravertebral Block (PVB) combined with general anesthesia (GA) is a conventional pain&#xD;
      treatment for breast surgery but sometimes failures can occurs. The efficacy of this block&#xD;
      has to be evaluated. Also, for the intra-operative analgesic evaluation of this block, it is&#xD;
      necessary to measure intra-operative analgesia index. A monitor of nociception for patients&#xD;
      under GA, the PhysiodolorisTM device, offers an index for measuring nociceptive inputs during&#xD;
      surgery in anesthetized patients : the ANI index (based on the single R-R interval analysis).&#xD;
      The purpose of this observational and prospective study is to assess the variations of this&#xD;
      ANI index during breast surgery with or without axillary node dissection with a PVB. This&#xD;
      will allow us to quantify the analgesic effect of a PVB during GA for unilateral radical&#xD;
      breast surgery with or without axillary node dissection.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 2, 2019</start_date>
  <completion_date type="Actual">March 1, 2023</completion_date>
  <primary_completion_date type="Actual">June 26, 2020</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>26 Months</target_duration>
  <primary_outcome>
    <measure>Assessment of the ANI index</measure>
    <time_frame>first minute of the surgical incision</time_frame>
    <description>Assessment of the area under the curve of the variation of the ANI index for the first minute of the surgical incision according to the PVB failure: incomplete or ineffective vs effective. The PVB failure will be evaluate with a cold test on the thoracic levels T2 and T6.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post Anesthesia Care Unit total dose of morphine will be compare according to the PVB failure or not groups.</measure>
    <time_frame>Just after surgery (day 0)</time_frame>
    <description>Post Anesthesia Care Unit total dose of morphine will be compare according to the PVB failure or not groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of pain</measure>
    <time_frame>Just after surgery (day 0) and the day after surgery (day 1)</time_frame>
    <description>Evaluation of the Numerical Rating Score (NRS) (no pain = 0, worst pain =10): NRS at arrival in the post anesthesia care unit , NRS at leaving of the post anesthesia care unit and at the postoperative day 1. NRS will be compare according to the PVB failure</description>
  </secondary_outcome>
  <enrollment type="Actual">100</enrollment>
  <condition>Breast Cancer</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Analgesia Nociception Index</intervention_name>
    <description>A monitor of nociception for patients under general anesthesia</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        women undergo for a breast surgery with or without axillary node dissection&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists score (ASA) I or II&#xD;
&#xD;
          -  Woman&#xD;
&#xD;
          -  Patients aged over 18 years&#xD;
&#xD;
          -  BMI between 17 and 30 kg/m2&#xD;
&#xD;
          -  Radical mastectomy with or without axillary node dissection.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Preoperative consumption of opioid&#xD;
&#xD;
          -  Local Anesthesia allergy&#xD;
&#xD;
          -  Local skin inflammation at the puncture area&#xD;
&#xD;
          -  Inability to respond to pain assessment using a Numerical Rating Score (NRS)&#xD;
&#xD;
          -  Any contra-indication or patient's refusal for regional anesthesia B blocker&#xD;
             medication&#xD;
&#xD;
          -  Pace maker&#xD;
&#xD;
          -  Inability to perform the PVB (at the appreciation of the anesthesiologist)&#xD;
&#xD;
          -  Change of surgical procedure other modified radical mastectomy with or without&#xD;
             axillary node dissection.&#xD;
&#xD;
          -  Patient with a severe side effect or who cannot be controlled by additional therapy&#xD;
             will be removed from the trial&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>RAFT JULIEN, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Institut de Cancérologie de Lorraine (ICL)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Institut de Cancérologie de Lorraine (ICL)</name>
      <address>
        <city>Vandœuvre-lès-Nancy</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>June 21, 2023</last_update_submitted>
  <last_update_submitted_qc>June 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>general anesthesia</keyword>
  <keyword>paravertebral Block</keyword>
  <keyword>analgesia nociception index</keyword>
  <!-- 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/NCT03832920
org study id: 2019-A00121-56
nct id: NCT03832920
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Paravertebral Block (PVB) combined with general anesthesia (GA) is a conventional pain
      treatment for breast surgery but sometimes failures can occurs. The efficacy of this block
      has to be evaluated. Also, for the intra-operative analgesic evaluation of this block, it is
      necessary to measure intra-operative analgesia index. A monitor of nociception for patients
      under GA, the PhysiodolorisTM device, offers an index for measuring nociceptive inputs during
      surgery in anesthetized patients : the ANI index (based on the single R-R interval analysis).
      The purpose of this observational and prospective study is to assess the variations of this
      ANI index during breast surgery with or without axillary node dissection with a PVB. This
      will allow us to quantify the analgesic effect of a PVB during GA for unilateral radical
      breast surgery with or without axillary node dissection.
observational model: Cohort
time perspective: Prospective
measure: Assessment of the ANI index
time frame: first minute of the surgical incision
description: Assessment of the area under the curve of the variation of the ANI index for the first minute of the surgical incision according to the PVB failure: incomplete or ineffective vs effective. The PVB failure will be evaluate with a cold test on the thoracic levels T2 and T6.
measure: Post Anesthesia Care Unit total dose of morphine will be compare according to the PVB failure or not groups.
time frame: Just after surgery (day 0)
description: Post Anesthesia Care Unit total dose of morphine will be compare according to the PVB failure or not groups.
measure: Evaluation of pain
time frame: Just after surgery (day 0) and the day after surgery (day 1)
description: Evaluation of the Numerical Rating Score (NRS) (no pain = 0, worst pain =10): NRS at arrival in the post anesthesia care unit , NRS at leaving of the post anesthesia care unit and at the postoperative day 1. NRS will be compare according to the PVB failure
intervention type: Other
intervention name: Analgesia Nociception Index
description: A monitor of nociception for patients under general anesthesia
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: RAFT JULIEN, MD
role: Principal Investigator
affiliation: Institut de Cancérologie de Lorraine (ICL)
facility: 
country: France
responsible party type: Sponsor