<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/NCT03238430</url>
  </required_header>
  <id_info>
    <org_study_id>2013_48</org_study_id>
    <secondary_id>2014-003317-28</secondary_id>
    <nct_id>NCT03238430</nct_id>
  </id_info>
  <brief_title>Management of Pain Post Hepatectomy : Infiltration of Local Anesthetics Versus Continuous Spinal Analgesia .</brief_title>
  <acronym>CATHEPAT</acronym>
  <official_title>Management of Pain Post Hepatectomy : Infiltration of Local Anesthetics Versus Continuous Spinal Analgesia .</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Lille</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Analgesia in liver surgery is a challenge, postoperative coagulopathy risk raises fears an&#xD;
      epidural haematoma formation following the epidural analgesia, &quot;gold standard&quot; in major&#xD;
      abdominal surgery. The spinal analgesia and/or continuous wound infiltration of local&#xD;
      anesthetics constitute so an alternative.&#xD;
&#xD;
      The study will compare the continuous infiltration of local anesthetics and rachianalgesia in&#xD;
      terms of decreased postoperative morphine consumption and incidences of chronic postoperative&#xD;
      pain at 3 and 6 months after hepatic surgery compared to the control group.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 20, 2015</start_date>
  <completion_date type="Actual">May 25, 2019</completion_date>
  <primary_completion_date type="Actual">May 25, 2019</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Morphine Consumption</measure>
    <time_frame>During the first 24 hours post operative</time_frame>
    <description>Morphine consumption is measured all 3 hours during the first 24 hours post operative</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Morphine Consumption</measure>
    <time_frame>During the 48 hours post operative</time_frame>
    <description>Morphine consumption is measured all 3 hours during the 48 hours post operative</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of postoperative pain intensity at rest</measure>
    <time_frame>All 3 hours during the 48 postoperative hours</time_frame>
    <description>The postoperative pain intensity is measured by Visual Analog Scale at rest</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of postoperative pain intensity after activity</measure>
    <time_frame>All 3 hours during the 48 postoperative hours</time_frame>
    <description>The postoperative pain intensity is measured by Visual Analog Scale after activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electric nociception threshold measured by PainMatcher</measure>
    <time_frame>At the exit of Post Anesthesia Care Unit</time_frame>
    <description>The Electric nociception threshold is measured by PainMatcher (CefarCompex®)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electric nociception threshold measured by PainMatcher</measure>
    <time_frame>At 24 hours post operative</time_frame>
    <description>The Electric nociception threshold is measured by PainMatcher (CefarCompex®)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electric nociception threshold measured by PainMatcher</measure>
    <time_frame>At 48 hours post operative</time_frame>
    <description>The Electric nociception threshold is measured by PainMatcher (CefarCompex®)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patient with a chronic pain after liver surgery, measured by Questionnaire Douleur de Saint-Antoine (QDSA)</measure>
    <time_frame>At 3 months after surgery</time_frame>
    <description>Evaluation with validated score for chronic and neuropathic pains (QDSA is the French translation of the MPQ &quot;Mac Gill bread questionary&quot;)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patient with a chronic pain after liver surgery, measured by Questionnaire Douleur de Saint-Antoine (QDSA)</measure>
    <time_frame>At 6 months after surgery</time_frame>
    <description>Evaluation with validated score for chronic and neuropathic pains (QDSA is the French translation of the MPQ &quot;Mac Gill bread questionary&quot;)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patient with a chronic pain after liver surgery, measured by Neuropathic Pain Symptom Inventory (NPSI)</measure>
    <time_frame>At 3 months after surgery</time_frame>
    <description>Evaluation with validated score for chronic and neuropathic pains (NPSI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patient with a chronic pain after liver surgery, measured by Neuropathic Pain Symptom Inventory (NPSI),</measure>
    <time_frame>At 6 months after surgery</time_frame>
    <description>Evaluation with validated score for chronic and neuropathic pains (NPSI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patient with a chronic pain after liver surgery, measured by Neuropathic pain diagnostic questionnaire (DN2),</measure>
    <time_frame>At 3 months after surgery</time_frame>
    <description>Evaluation with validated score for chronic and neuropathic pains (DN2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patient with a chronic pain after liver surgery, measured by Neuropathic pain diagnostic questionnaire (DN2),</measure>
    <time_frame>At 6 months after surgery</time_frame>
    <description>Evaluation with validated score for chronic and neuropathic pains (DN2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Area peri-incisional hyperalgesia</measure>
    <time_frame>At 48 hours post operative</time_frame>
    <description>The Surface of the cutaneous Area peri-incisional hyperalgesia is measured by Von frey's Filament.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of nausea and/or vomiting episodes</measure>
    <time_frame>At 24 hours after surgery</time_frame>
    <description>Measured by collection of episodes of nausea and/or vomiting and consumption of anti-emetics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of nausea and/or vomiting episodes</measure>
    <time_frame>At 48 hours after surgery</time_frame>
    <description>Measured by collection of episodes of nausea and/or vomiting and consumption of anti-emetics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of nausea and/or vomiting episodes</measure>
    <time_frame>At 72 hours after surgery</time_frame>
    <description>Measured by collection of episodes of nausea and/or vomiting and consumption of anti-emetics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patient with side effect of morphine consumption</measure>
    <time_frame>Up to 72 hours after surgery</time_frame>
    <description>Respiratory Depression, Urinary retention, Prurit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time physiological function recovery</measure>
    <time_frame>Up to the end of hospital stay, an average 10 days</time_frame>
    <description>Nasogastric tube withdrawal time, Transit recovery, Ability to drink, to eat, to urinate, to walk</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay in intensive care unit</measure>
    <time_frame>Up to the end of hospital stay,an average 10 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>Up to the end of hospital stay , an average 10 days</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">186</enrollment>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>Ropivacaine infiltration</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Continuous infiltration of local anesthetics + PCA morphine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>intrathecal morphine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Rachianalgesia + PCA morphine</description>
  </arm_group>
  <arm_group>
    <arm_group_label>morphine PCA</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>PCA morphine alone</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>intrathecal morphine</intervention_name>
    <description>A single intrathecal injection of 300 micrograms of Morphine preoperatively, just before induction.</description>
    <arm_group_label>Ropivacaine infiltration</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Morphine PCA</intervention_name>
    <description>a postoperative Morphine PCA</description>
    <arm_group_label>Ropivacaine infiltration</arm_group_label>
    <arm_group_label>intrathecal morphine</arm_group_label>
    <arm_group_label>morphine PCA</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ropivacaine infiltration</intervention_name>
    <description>Ropivacaine 2mg / ml at the rate of 8ml per hour via a multiperforated catheter with connector after bolus of 20 ml</description>
    <arm_group_label>intrathecal morphine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Surgery of hepatic resection by first under costal.&#xD;
&#xD;
          -  Patient classified ASA 1 to 3.&#xD;
&#xD;
          -  Information, signed and informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients classified ASA 4 or 5.&#xD;
&#xD;
          -  Allergy or intolerance to any of the products used in the protocol.&#xD;
&#xD;
          -  Emergency surgery, palliative surgery, surgical recovery.&#xD;
&#xD;
          -  History of chronic pain requiring the regular use of analgesics, especially opioids.&#xD;
&#xD;
          -  History of drug misuse.&#xD;
&#xD;
          -  Inability to understand and / or use the patient's self-controlled morphine pump.&#xD;
&#xD;
          -  Known history of psychiatric disorders or current psychotropic treatment (excluding&#xD;
             benzodiazepine monotherapy)&#xD;
&#xD;
          -  Additive behavior with respect to alcohol or non-weaned psychodysleptic substances&#xD;
&#xD;
          -  Pregnant Woman or Breastfeeding&#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>Gilles Lebuffe, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHRU de Lille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHRU , Hôpital Claude Huriez</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>October 13, 2022</last_update_submitted>
  <last_update_submitted_qc>October 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 14, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Intrathecal morphine, continuous wound infiltration</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Morphine</mesh_term>
    <mesh_term>Ropivacaine</mesh_term>
  </intervention_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/NCT03238430
org study id: 2013_48
secondary id: 2014-003317-28
nct id: NCT03238430
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Analgesia in liver surgery is a challenge, postoperative coagulopathy risk raises fears an
      epidural haematoma formation following the epidural analgesia, "gold standard" in major
      abdominal surgery. The spinal analgesia and/or continuous wound infiltration of local
      anesthetics constitute so an alternative.

      The study will compare the continuous infiltration of local anesthetics and rachianalgesia in
      terms of decreased postoperative morphine consumption and incidences of chronic postoperative
      pain at 3 and 6 months after hepatic surgery compared to the control group.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Morphine Consumption
time frame: During the first 24 hours post operative
description: Morphine consumption is measured all 3 hours during the first 24 hours post operative
measure: Morphine Consumption
time frame: During the 48 hours post operative
description: Morphine consumption is measured all 3 hours during the 48 hours post operative
measure: Evaluation of postoperative pain intensity at rest
time frame: All 3 hours during the 48 postoperative hours
description: The postoperative pain intensity is measured by Visual Analog Scale at rest
measure: Evaluation of postoperative pain intensity after activity
time frame: All 3 hours during the 48 postoperative hours
description: The postoperative pain intensity is measured by Visual Analog Scale after activity
measure: Electric nociception threshold measured by PainMatcher
time frame: At the exit of Post Anesthesia Care Unit
description: The Electric nociception threshold is measured by PainMatcher (CefarCompex®)
measure: Electric nociception threshold measured by PainMatcher
time frame: At 24 hours post operative
description: The Electric nociception threshold is measured by PainMatcher (CefarCompex®)
measure: Electric nociception threshold measured by PainMatcher
time frame: At 48 hours post operative
description: The Electric nociception threshold is measured by PainMatcher (CefarCompex®)
measure: Number of patient with a chronic pain after liver surgery, measured by Questionnaire Douleur de Saint-Antoine (QDSA)
time frame: At 3 months after surgery
description: Evaluation with validated score for chronic and neuropathic pains (QDSA is the French translation of the MPQ "Mac Gill bread questionary")
measure: Number of patient with a chronic pain after liver surgery, measured by Questionnaire Douleur de Saint-Antoine (QDSA)
time frame: At 6 months after surgery
description: Evaluation with validated score for chronic and neuropathic pains (QDSA is the French translation of the MPQ "Mac Gill bread questionary")
measure: Number of patient with a chronic pain after liver surgery, measured by Neuropathic Pain Symptom Inventory (NPSI)
time frame: At 3 months after surgery
description: Evaluation with validated score for chronic and neuropathic pains (NPSI)
measure: Number of patient with a chronic pain after liver surgery, measured by Neuropathic Pain Symptom Inventory (NPSI),
time frame: At 6 months after surgery
description: Evaluation with validated score for chronic and neuropathic pains (NPSI)
measure: Number of patient with a chronic pain after liver surgery, measured by Neuropathic pain diagnostic questionnaire (DN2),
time frame: At 3 months after surgery
description: Evaluation with validated score for chronic and neuropathic pains (DN2)
measure: Number of patient with a chronic pain after liver surgery, measured by Neuropathic pain diagnostic questionnaire (DN2),
time frame: At 6 months after surgery
description: Evaluation with validated score for chronic and neuropathic pains (DN2)
measure: Area peri-incisional hyperalgesia
time frame: At 48 hours post operative
description: The Surface of the cutaneous Area peri-incisional hyperalgesia is measured by Von frey's Filament.
measure: Number of nausea and/or vomiting episodes
time frame: At 24 hours after surgery
description: Measured by collection of episodes of nausea and/or vomiting and consumption of anti-emetics
measure: Number of nausea and/or vomiting episodes
time frame: At 48 hours after surgery
description: Measured by collection of episodes of nausea and/or vomiting and consumption of anti-emetics
measure: Number of nausea and/or vomiting episodes
time frame: At 72 hours after surgery
description: Measured by collection of episodes of nausea and/or vomiting and consumption of anti-emetics
measure: Number of patient with side effect of morphine consumption
time frame: Up to 72 hours after surgery
description: Respiratory Depression, Urinary retention, Prurit
measure: Time physiological function recovery
time frame: Up to the end of hospital stay, an average 10 days
description: Nasogastric tube withdrawal time, Transit recovery, Ability to drink, to eat, to urinate, to walk
measure: Length of hospital stay in intensive care unit
time frame: Up to the end of hospital stay,an average 10 days
measure: Length of hospital stay
time frame: Up to the end of hospital stay , an average 10 days
arm group label: Ropivacaine infiltration
arm group type: Experimental
description: Continuous infiltration of local anesthetics + PCA morphine.
arm group label: intrathecal morphine
arm group type: Experimental
description: Rachianalgesia + PCA morphine
arm group label: morphine PCA
arm group type: Active Comparator
description: PCA morphine alone
intervention type: Drug
intervention name: intrathecal morphine
description: A single intrathecal injection of 300 micrograms of Morphine preoperatively, just before induction.
arm group label: Ropivacaine infiltration
intervention type: Drug
intervention name: Morphine PCA
description: a postoperative Morphine PCA
arm group label: Ropivacaine infiltration
arm group label: intrathecal morphine
arm group label: morphine PCA
intervention type: Drug
intervention name: Ropivacaine infiltration
description: Ropivacaine 2mg / ml at the rate of 8ml per hour via a multiperforated catheter with connector after bolus of 20 ml
arm group label: intrathecal morphine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Gilles Lebuffe, MD, PhD
role: Principal Investigator
affiliation: CHRU de Lille
facility: 
country: France
responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Morphine
mesh term: Ropivacaine