<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/NCT02257164</url>
  </required_header>
  <id_info>
    <org_study_id>1408021</org_study_id>
    <secondary_id>2014-002062-77</secondary_id>
    <nct_id>NCT02257164</nct_id>
  </id_info>
  <brief_title>Anesthesic Techniques for Surgery of the Anterior Cruciate Ligament of the Knee in Ambulatory Surgery. Randomized Pilot Monocentric Trial</brief_title>
  <acronym>CLICA</acronym>
  <official_title>Anesthesic Techniques for Surgery of the Anterior Cruciate Ligament of the Knee in Ambulatory Surgery. Randomized Pilot Monocentric Trial</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Surgery of the anterior cruciate ligament of the knee is frequently a young patient surgery.&#xD;
      The post-operative pain of this surgery is managed according to recommendation. In the&#xD;
      majority of case, femoral nerve block is performed. The femoral nerve block can cause&#xD;
      &quot;paralysis&quot; of the quadriceps more or less complete that no allowing a good quadriceps&#xD;
      locking. This locking is indispensable to avoid post-operative flexima and to ensure&#xD;
      stabilization of the knee during walking.&#xD;
&#xD;
      In France, the surgery requires a duration of hospitalization from 2 to 4 days in the most&#xD;
      cases. It is sometimes performed in ambulatory especially in the USA. But, at the home, pain&#xD;
      requires powerful analgesics with their adverse events.&#xD;
&#xD;
      Today, no anesthesic technics for surgery of anterior cruciate ligament of the knee ensure in&#xD;
      the same time optimal analgesia and optimal quadriceps locking. The main objective of the&#xD;
      investigators study is to compare two analgesia techniques : femoral nerve block vs intra&#xD;
      articular injection and obturator nerve block in surgery of the anterior cruciate ligament of&#xD;
      the knee&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</primary_completion_date>
  <phase>Phase 4</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>number of patients with success</measure>
    <time_frame>4 postoperative hours</time_frame>
    <description>success is defined by : score chung &gt; or egal to 9 and quadriceps locking &gt; or egal to 3/5</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain for all patients</measure>
    <time_frame>Postoperative hours : 0, 1, 2, 4, 6, 8, 12, 18, 24, 36 and 48</time_frame>
    <description>pain measured by EVA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>analgesic consumption for all patients</measure>
    <time_frame>Postoperative hours : 0, 1, 2, 4, 6, 8, 12, 18, 24, 36 and 48</time_frame>
    <description>analgesic consumption of tramadol and morphine (use, number)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>analgesic adverse events for all patients</measure>
    <time_frame>Postoperative hours : 0, 1, 2, 4, 6, 8, 12, 18, 24, 36 and 48</time_frame>
    <description>Frequency of nausea and vomiting</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Anterior Cruciate Ligament Reconstruction</condition>
  <arm_group>
    <arm_group_label>femoral nerve block</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>20 ml injection of 2 mg/ml ropivacaine in femoral nerve</description>
  </arm_group>
  <arm_group>
    <arm_group_label>obturator nerve block and intraarticular injection</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>10 ml injection of 2 mg/ml ropivacaine in obturator nerve intraarticular injection : 10 ml of chlorhydrate ropivacaine (2 mg/ml) and 10ml of magnesium sulfate</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Femoral nerve block</intervention_name>
    <description>2 mg/ml</description>
    <arm_group_label>femoral nerve block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>obturator nerve block</intervention_name>
    <arm_group_label>obturator nerve block and intraarticular injection</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>intraarticular injection</intervention_name>
    <arm_group_label>obturator nerve block and intraarticular injection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Physical Status score = 1 or Physical Status score = 2&#xD;
&#xD;
          -  Major Patient&#xD;
&#xD;
          -  indication of anterior cruciate ligament reconstruction&#xD;
&#xD;
          -  informed consent for participation in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication to general analgesia&#xD;
&#xD;
          -  Contraindication to peripheral nerve block&#xD;
&#xD;
          -  Allergy to analgesic treatment&#xD;
&#xD;
          -  Porphyria,&#xD;
&#xD;
          -  Neurologic deficit&#xD;
&#xD;
          -  Contraindication antiinflammatory drugs&#xD;
&#xD;
          -  Simultaneous reconstruction of another ligament or complex gesture intended&#xD;
&#xD;
          -  Patient treated with an anti-arrhythmic drug class III&#xD;
&#xD;
          -  Patient with severe hepatic impairment&#xD;
&#xD;
          -  Pregnant woman&#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>Sylvie PASSOT, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU de Saint-Etienne</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>PASSOT</name>
      <address>
        <city>Saint-etienne</city>
        <zip>42055</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2015</verification_date>
  <study_first_submitted>September 30, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 6, 2014</study_first_posted>
  <last_update_submitted>June 30, 2015</last_update_submitted>
  <last_update_submitted_qc>June 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 1, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>anterior cruciate ligament reconstruction</keyword>
  <keyword>femoral nerve block</keyword>
  <keyword>articular injection and obturator nerve block</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/NCT02257164
org study id: 1408021
secondary id: 2014-002062-77
nct id: NCT02257164
lead sponsor: 
has dmc: No
Surgery of the anterior cruciate ligament of the knee is frequently a young patient surgery.
      The post-operative pain of this surgery is managed according to recommendation. In the
      majority of case, femoral nerve block is performed. The femoral nerve block can cause
      "paralysis" of the quadriceps more or less complete that no allowing a good quadriceps
      locking. This locking is indispensable to avoid post-operative flexima and to ensure
      stabilization of the knee during walking.

      In France, the surgery requires a duration of hospitalization from 2 to 4 days in the most
      cases. It is sometimes performed in ambulatory especially in the USA. But, at the home, pain
      requires powerful analgesics with their adverse events.

      Today, no anesthesic technics for surgery of anterior cruciate ligament of the knee ensure in
      the same time optimal analgesia and optimal quadriceps locking. The main objective of the
      investigators study is to compare two analgesia techniques : femoral nerve block vs intra
      articular injection and obturator nerve block in surgery of the anterior cruciate ligament of
      the knee
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: number of patients with success
time frame: 4 postoperative hours
description: success is defined by : score chung > or egal to 9 and quadriceps locking > or egal to 3/5
measure: Pain for all patients
time frame: Postoperative hours : 0, 1, 2, 4, 6, 8, 12, 18, 24, 36 and 48
description: pain measured by EVA
measure: analgesic consumption for all patients
time frame: Postoperative hours : 0, 1, 2, 4, 6, 8, 12, 18, 24, 36 and 48
description: analgesic consumption of tramadol and morphine (use, number)
measure: analgesic adverse events for all patients
time frame: Postoperative hours : 0, 1, 2, 4, 6, 8, 12, 18, 24, 36 and 48
description: Frequency of nausea and vomiting
arm group label: femoral nerve block
arm group type: Active Comparator
description: 20 ml injection of 2 mg/ml ropivacaine in femoral nerve
arm group label: obturator nerve block and intraarticular injection
arm group type: Experimental
description: 10 ml injection of 2 mg/ml ropivacaine in obturator nerve intraarticular injection : 10 ml of chlorhydrate ropivacaine (2 mg/ml) and 10ml of magnesium sulfate
intervention type: Procedure
intervention name: Femoral nerve block
description: 2 mg/ml
arm group label: femoral nerve block
intervention type: Procedure
intervention name: obturator nerve block
arm group label: obturator nerve block and intraarticular injection
intervention type: Procedure
intervention name: intraarticular injection
arm group label: obturator nerve block and intraarticular injection
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Sylvie PASSOT, MD
role: Principal Investigator
affiliation: CHU de Saint-Etienne
facility: 
country: France
responsible party type: Sponsor