<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/NCT02969733</url>
  </required_header>
  <id_info>
    <org_study_id>2009_05/0943</org_study_id>
    <secondary_id>2009-017682-33</secondary_id>
    <nct_id>NCT02969733</nct_id>
  </id_info>
  <brief_title>The Interest of the Xylocaine® and Ketamine on the Management of Acute and Chronic Ain After Colectomy by Laparoscopy</brief_title>
  <acronym>KETALIDO</acronym>
  <official_title>The Interest of the Xylocaine® and Ketamine on the Per and Postoperative Management of Acute and Chronic Postoperative Pain After Colectomy by Laparoscopy</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>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Recent clinical studies in abdominal surgery have shown that the use of Xylocaine®&#xD;
      parenterally intraoperative at plasma concentrations below the toxic threshold of 5 .mu.g /&#xD;
      ml, had an analgesic effect and decreased postoperative morphine consumption.&#xD;
&#xD;
      This study aims to evaluate the activity of Xylocaine® and ketamine separately administered&#xD;
      parenterally, in terms of postoperative morphine consumption and decrease incidences of&#xD;
      postoperative chronic pain at 3 and 6 months after laparoscopic colectomy compared the&#xD;
      placebo group.&#xD;
&#xD;
      The evaluation of the intensity of postoperative pain, hyperalgesia perished skin surface&#xD;
      scarring) and pain perception threshold by Pain Matcher® confirm or not the predictive nature&#xD;
      of these criteria in the occurrence of chronic pain.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2011</start_date>
  <completion_date type="Actual">September 2017</completion_date>
  <primary_completion_date type="Actual">September 2017</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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Morphine consumption</measure>
    <time_frame>During the first 24 postoperative hours.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Morphine consumption</measure>
    <time_frame>All 6 hours during the 48 postoperative hours.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numeric rating scale score</measure>
    <time_frame>All 2 hours during the first 24 postoperative hours and all 6 hours during the 48 postoperative hours.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Electric nociception threshold measured by PainMatcher</measure>
    <time_frame>All 2 hours during the first 24 postoperative hours and all 6 hours during the 48 postoperative hours.</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hyperalgesia of peri-scar (in cm²) with a von Frey filament (pressure of 10 grams</measure>
    <time_frame>At 2 days after postoperative</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaire Douleur de Saint-Antoine (QDSA) ,</measure>
    <time_frame>at 3 months, at 6 months</time_frame>
    <description>evaluation with validated scores for chronic and neuropathic pains</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Questionnaire d'Evaluation des Douleurs Neuropathiques (QEDN),</measure>
    <time_frame>at 3 months, at 6 months</time_frame>
    <description>evaluation with validated scores for chronic and neuropathic pains</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time physiological function recovery</measure>
    <time_frame>During the first 24 postoperative hours</time_frame>
    <description>Ability to drink, to eat, to urinate, to walk</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of hospital stay</measure>
    <time_frame>At 5 days after postoperative</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">135</enrollment>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>Xylocaine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intravenous administration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ketamine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>intravenous administration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>isotonic saline serum</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>isotonic saline serum intravenous administration</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Xylocaine</intervention_name>
    <description>Xylocaine is administered at a dose of 1.5 mg / kg for induction and then relay by syringe pump at a dose of 1.33 mg / kg / hour will be administered throughout the duration of the intervention and for 24 hours after the end of thereof, to obtain deemed effective plasma concentrations of the order of 0.5 to 5 mcg / mL.</description>
    <arm_group_label>Xylocaine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketamine</intervention_name>
    <description>Ketamine will be administered at a dose of 0.5 mg / kg and then relay by syringe pump at a dose of 0.05 mg / kg / hour for the duration of surgery and 24 hours after the end thereof.</description>
    <arm_group_label>Ketamine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>isotonic saline serum intravenous administration</intervention_name>
    <arm_group_label>isotonic saline serum</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Surgery: segmental or total colectomy performed by laparoscopy&#xD;
&#xD;
          -  Anesthesia state 1 and 3&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients classified Anesthesia state 4 or 5&#xD;
&#xD;
          -  Allergy or intolerance to any of the products used in the protocol&#xD;
&#xD;
          -  Creatinine clearance calculated by the Cockcroft formula below 50 ml / min&#xD;
&#xD;
          -  Hepatocellular insufficiency&#xD;
&#xD;
          -  Severe heart failure&#xD;
&#xD;
          -  Peptic ulcer&#xD;
&#xD;
          -  Chronic inflammatory bowel disease (IBD)&#xD;
&#xD;
          -  Previous history of epilepsy or seizures&#xD;
&#xD;
          -  Surgery emergency, palliative surgery, revision surgery&#xD;
&#xD;
          -  Chronic pain requiring regular intake of analgesics include opioids&#xD;
&#xD;
          -  Patients treated with lidocaine patch&#xD;
&#xD;
          -  Psychic Disorder&#xD;
&#xD;
          -  Additive Conduct vis-à-vis alcohol or mind-altering substances&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#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>Gilles Lebuffe, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, 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>September 2017</verification_date>
  <study_first_submitted>November 14, 2016</study_first_submitted>
  <study_first_submitted_qc>November 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2016</study_first_posted>
  <last_update_submitted>September 11, 2017</last_update_submitted>
  <last_update_submitted_qc>September 11, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 12, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>postoperative analgesia</keyword>
  <keyword>PainMatcher</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>Lidocaine</mesh_term>
    <mesh_term>Ketamine</mesh_term>
  </intervention_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/NCT02969733
org study id: 2009_05/0943
secondary id: 2009-017682-33
nct id: NCT02969733
lead sponsor: 
has dmc: No
Recent clinical studies in abdominal surgery have shown that the use of Xylocaine®
      parenterally intraoperative at plasma concentrations below the toxic threshold of 5 .mu.g /
      ml, had an analgesic effect and decreased postoperative morphine consumption.

      This study aims to evaluate the activity of Xylocaine® and ketamine separately administered
      parenterally, in terms of postoperative morphine consumption and decrease incidences of
      postoperative chronic pain at 3 and 6 months after laparoscopic colectomy compared the
      placebo group.

      The evaluation of the intensity of postoperative pain, hyperalgesia perished skin surface
      scarring) and pain perception threshold by Pain Matcher® confirm or not the predictive nature
      of these criteria in the occurrence of chronic pain.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Morphine consumption
time frame: During the first 24 postoperative hours.
measure: Morphine consumption
time frame: All 6 hours during the 48 postoperative hours.
measure: Numeric rating scale score
time frame: All 2 hours during the first 24 postoperative hours and all 6 hours during the 48 postoperative hours.
measure: Electric nociception threshold measured by PainMatcher
time frame: All 2 hours during the first 24 postoperative hours and all 6 hours during the 48 postoperative hours.
measure: Hyperalgesia of peri-scar (in cm²) with a von Frey filament (pressure of 10 grams
time frame: At 2 days after postoperative
measure: Questionnaire Douleur de Saint-Antoine (QDSA) ,
time frame: at 3 months, at 6 months
description: evaluation with validated scores for chronic and neuropathic pains
measure: Questionnaire d'Evaluation des Douleurs Neuropathiques (QEDN),
time frame: at 3 months, at 6 months
description: evaluation with validated scores for chronic and neuropathic pains
measure: Time physiological function recovery
time frame: During the first 24 postoperative hours
description: Ability to drink, to eat, to urinate, to walk
measure: Duration of hospital stay
time frame: At 5 days after postoperative
arm group label: Xylocaine
arm group type: Experimental
description: intravenous administration
arm group label: Ketamine
arm group type: Experimental
description: intravenous administration
arm group label: isotonic saline serum
arm group type: Placebo Comparator
description: isotonic saline serum intravenous administration
intervention type: Drug
intervention name: Xylocaine
description: Xylocaine is administered at a dose of 1.5 mg / kg for induction and then relay by syringe pump at a dose of 1.33 mg / kg / hour will be administered throughout the duration of the intervention and for 24 hours after the end of thereof, to obtain deemed effective plasma concentrations of the order of 0.5 to 5 mcg / mL.
arm group label: Xylocaine
intervention type: Drug
intervention name: Ketamine
description: Ketamine will be administered at a dose of 0.5 mg / kg and then relay by syringe pump at a dose of 0.05 mg / kg / hour for the duration of surgery and 24 hours after the end thereof.
arm group label: Ketamine
intervention type: Drug
intervention name: isotonic saline serum intravenous administration
arm group label: isotonic saline serum
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gilles Lebuffe, MD, PhD
role: Principal Investigator
affiliation: University Hospital, Lille
facility: 
country: France
responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Lidocaine
mesh term: Ketamine
sharing ipd: No