<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/NCT04499716</url>
  </required_header>
  <id_info>
    <org_study_id>2020/04</org_study_id>
    <nct_id>NCT04499716</nct_id>
  </id_info>
  <brief_title>Quadriblock Versus &quot;IPACK + Femoral Triangle Block + Obturator Nerve Block&quot; in Total Knee Arthroplasty</brief_title>
  <acronym>QuITO</acronym>
  <official_title>Quadriblock Versus &quot;IPACK + Femoral Triangle Block + Obturator Nerve Block&quot; in Total Knee Arthroplasty: a Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clinique Medipole Garonne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Clinique Medipole Garonne</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Total knee arthroplasty (TKA) is one of the most common orthopedic surgical procedure and is&#xD;
      associated with severe pain in the immediate postoperative period, thus limiting early&#xD;
      recovery.&#xD;
&#xD;
      Postoperative pain management requires multimodal analgesia, combining drugs and injection of&#xD;
      a local anesthetic (LA). For optimal pain management, several peripheral nerve blocks should&#xD;
      be associated. Thus, a recent study shows that the combination of IPACK, femoral triangle and&#xD;
      obturator nerve blocks (ITO blocks) provides an effective pain control after TKA.&#xD;
&#xD;
      The hypothesis of this study is that a quadruple nerve block combining femoral, sciatic,&#xD;
      obturator and lateral femoral cutaneous nerve blocks (quadri-block) could improve analgesia&#xD;
      after TKA.&#xD;
&#xD;
      The main objective of this monocenter, prospective, randomized, open-label, controlled trial&#xD;
      is to assess the effect of quadri-block on morphine consumption after TKA compared to ITO&#xD;
      blocks.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the pre-anaesthesia room, after the implementation of classical monitoring with an oxygen&#xD;
      mask and a peripheral venous catheter, all patients will receive an antibioprophylaxis&#xD;
      according to SFAR (French Society of Anesthesia &amp; Intensive Care Medecine) recommendations&#xD;
      and injection of 10 mg of IV dexamethasone.&#xD;
&#xD;
      The patients will be then randomized in 2 groups:&#xD;
&#xD;
        -  ITO group (usual technique): IPACK combined to femoral triangle and obturator nerve&#xD;
           blocks&#xD;
&#xD;
        -  Quadriblock group (experimental technique): femoral, sciatic, obturator and lateral&#xD;
           femoral cutaneous nerve blocks.&#xD;
&#xD;
      An experienced anesthetist will perform ultrasound-guided blocks 30 minutes before surgery&#xD;
      with ropivacaine 0.3%, total volume of 70 ml.&#xD;
&#xD;
      In the operating room, general anesthesia will be induced by intravenous ketamine (0.4 mg/kg)&#xD;
      and propofol (3 mg/kg). Anesthesia will be maintained with propofol.&#xD;
&#xD;
      Postoperative analgesia protocol :&#xD;
&#xD;
        -  Multimodal analgesia will be instituted from the end of the surgery by the&#xD;
           administration of paracetamol (1 g) and ketoprofen (100 mg).&#xD;
&#xD;
        -  In post-anesthesia care unit (PACU): oxynorm titration if VRS (pain score) &gt;3 according&#xD;
           to the centre's usual care.&#xD;
&#xD;
        -  In ward: systematic per os analgesia with paracetamol (1 g, 4 times a day) and ibuprofen&#xD;
           (400 mg, 3 times a day); oxynorm (10 mg, lockout interval: 4 h) if VRS (pain score) &gt;3.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 8, 2020</start_date>
  <completion_date type="Actual">May 7, 2021</completion_date>
  <primary_completion_date type="Actual">May 7, 2021</primary_completion_date>
  <phase>N/A</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>Other</primary_purpose>
    <masking>Double (Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative analgesia, defined by the morphine consumption in the first 48 hours post-surgery.</measure>
    <time_frame>48 hours</time_frame>
    <description>Total amount of oxynorm (mg) administered during the first 48 hours post-surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative pain: Verbal Rating Scale (VRS)</measure>
    <time_frame>48 hours</time_frame>
    <description>Pain will be assessed every 6 hours using a Verbal Rating Scale (VRS) ranging from 0 to 10 (0=no pain, 10=worst possible pain).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxynorm consumption in the first 24 hours post-surgery</measure>
    <time_frame>24 hours</time_frame>
    <description>Total amount of oxynorm (mg) administered during the first 24 hours post-surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ability to walk</measure>
    <time_frame>48 hours</time_frame>
    <description>0: unable to get up; 1: able to get up but not to walk; 2: walk &lt;50 m; 3: walk &gt; 50 m</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quadricep mobilization</measure>
    <time_frame>48 hours</time_frame>
    <description>0: paralysis; 1: paresis, 2: normal contraction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Foot elevator muscle mobilization</measure>
    <time_frame>48 hours</time_frame>
    <description>0: paralysis; 1: paresis; 2: normal contraction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side effects of opioids</measure>
    <time_frame>48 hours</time_frame>
    <description>Collect side effects associated with oxynorm : nausea or vomiting, drowsiness, constipation, urinary retention, itching, disorientation.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Primary Total Knee Arthroplasty</condition>
  <arm_group>
    <arm_group_label>Arm 1: ITO group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Arm 1: IPACK combined with femoral triangle and obturator nerve blocks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2 : Quadri-block group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Arm 2 : Femoral, sciatic, obturator and lateral femoral cutaneous nerve blocks</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>IPACK</intervention_name>
    <description>25 milliliters of ropivacaine 0.3% will be injected between popliteal artery and femur.</description>
    <arm_group_label>Arm 1: ITO group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Femoral triangle block</intervention_name>
    <description>25 milliliters of ropivacaine 0.3% will be injected on the lateral side of the femoral artery at the distal part of the femoral triangle.</description>
    <arm_group_label>Arm 1: ITO group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Obturator nerve block</intervention_name>
    <description>20 milliliters of ropivacaine 0.3% will be injected between the adductor magnus and adductor brevis muscles and between the adductor brevis muscle the pectineus.</description>
    <arm_group_label>Arm 1: ITO group</arm_group_label>
    <arm_group_label>Arm 2 : Quadri-block group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Femoral nerve block</intervention_name>
    <description>20 milliliters of ropivacaine 0.3% will be injected in supine position under the fascia iliaca lateral to the femoral artery.</description>
    <arm_group_label>Arm 2 : Quadri-block group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sciatic nerve block</intervention_name>
    <description>25 milliliters of ropivacaine 0.3% will be injected in prone position in the subgluteal space by lateral approach.</description>
    <arm_group_label>Arm 2 : Quadri-block group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Lateral femoral cutaneous nerve block</intervention_name>
    <description>5 milliliters of ropivacaine 0.3% will be injected laterally to the sartorius muscle.</description>
    <arm_group_label>Arm 2 : Quadri-block group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years and older,&#xD;
&#xD;
          -  Primary total knee arthroplasty&#xD;
&#xD;
          -  Consent for participation,&#xD;
&#xD;
          -  Affiliation to a social security system&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Preoperative morphine use&#xD;
&#xD;
          -  Chronic pain syndrome&#xD;
&#xD;
          -  Contraindication to any drugs used in the protocol (paracetamol, ketoprofen, oxynorm,&#xD;
             propofol, ketamine, ropivacaine)&#xD;
&#xD;
          -  Valgus &gt; 9°&#xD;
&#xD;
          -  Pregnant or breastfeeding women&#xD;
&#xD;
          -  Patients under protection of the adults (guardianship, curators or safeguard of&#xD;
             justice)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Clinique Médipôle Garonne</name>
      <address>
        <city>Toulouse</city>
        <state>Haute-Garonne</state>
        <zip>31036</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 31, 2020</study_first_submitted>
  <study_first_submitted_qc>August 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 5, 2020</study_first_posted>
  <last_update_submitted>June 4, 2021</last_update_submitted>
  <last_update_submitted_qc>June 4, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 7, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Knee arthroplasty, Regional anesthesia, Ropivacaine, Postoperative analgesia, Pain management, Opioids</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/NCT04499716
org study id: 2020/04
nct id: NCT04499716
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Total knee arthroplasty (TKA) is one of the most common orthopedic surgical procedure and is
      associated with severe pain in the immediate postoperative period, thus limiting early
      recovery.

      Postoperative pain management requires multimodal analgesia, combining drugs and injection of
      a local anesthetic (LA). For optimal pain management, several peripheral nerve blocks should
      be associated. Thus, a recent study shows that the combination of IPACK, femoral triangle and
      obturator nerve blocks (ITO blocks) provides an effective pain control after TKA.

      The hypothesis of this study is that a quadruple nerve block combining femoral, sciatic,
      obturator and lateral femoral cutaneous nerve blocks (quadri-block) could improve analgesia
      after TKA.

      The main objective of this monocenter, prospective, randomized, open-label, controlled trial
      is to assess the effect of quadri-block on morphine consumption after TKA compared to ITO
      blocks.
In the pre-anaesthesia room, after the implementation of classical monitoring with an oxygen
      mask and a peripheral venous catheter, all patients will receive an antibioprophylaxis
      according to SFAR (French Society of Anesthesia & Intensive Care Medecine) recommendations
      and injection of 10 mg of IV dexamethasone.

      The patients will be then randomized in 2 groups:

        -  ITO group (usual technique): IPACK combined to femoral triangle and obturator nerve
           blocks

        -  Quadriblock group (experimental technique): femoral, sciatic, obturator and lateral
           femoral cutaneous nerve blocks.

      An experienced anesthetist will perform ultrasound-guided blocks 30 minutes before surgery
      with ropivacaine 0.3%, total volume of 70 ml.

      In the operating room, general anesthesia will be induced by intravenous ketamine (0.4 mg/kg)
      and propofol (3 mg/kg). Anesthesia will be maintained with propofol.

      Postoperative analgesia protocol :

        -  Multimodal analgesia will be instituted from the end of the surgery by the
           administration of paracetamol (1 g) and ketoprofen (100 mg).

        -  In post-anesthesia care unit (PACU): oxynorm titration if VRS (pain score) >3 according
           to the centre's usual care.

        -  In ward: systematic per os analgesia with paracetamol (1 g, 4 times a day) and ibuprofen
           (400 mg, 3 times a day); oxynorm (10 mg, lockout interval: 4 h) if VRS (pain score) >3.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Care Provider, Outcomes Assessor)
measure: Postoperative analgesia, defined by the morphine consumption in the first 48 hours post-surgery.
time frame: 48 hours
description: Total amount of oxynorm (mg) administered during the first 48 hours post-surgery.
measure: Postoperative pain: Verbal Rating Scale (VRS)
time frame: 48 hours
description: Pain will be assessed every 6 hours using a Verbal Rating Scale (VRS) ranging from 0 to 10 (0=no pain, 10=worst possible pain).
measure: Oxynorm consumption in the first 24 hours post-surgery
time frame: 24 hours
description: Total amount of oxynorm (mg) administered during the first 24 hours post-surgery.
measure: Ability to walk
time frame: 48 hours
description: 0: unable to get up; 1: able to get up but not to walk; 2: walk <50 m; 3: walk > 50 m
measure: Quadricep mobilization
time frame: 48 hours
description: 0: paralysis; 1: paresis, 2: normal contraction
measure: Foot elevator muscle mobilization
time frame: 48 hours
description: 0: paralysis; 1: paresis; 2: normal contraction
measure: Side effects of opioids
time frame: 48 hours
description: Collect side effects associated with oxynorm : nausea or vomiting, drowsiness, constipation, urinary retention, itching, disorientation.
arm group label: Arm 1: ITO group
arm group type: Active Comparator
description: Arm 1: IPACK combined with femoral triangle and obturator nerve blocks
arm group label: Arm 2 : Quadri-block group
arm group type: Experimental
description: Arm 2 : Femoral, sciatic, obturator and lateral femoral cutaneous nerve blocks
intervention type: Procedure
intervention name: IPACK
description: 25 milliliters of ropivacaine 0.3% will be injected between popliteal artery and femur.
arm group label: Arm 1: ITO group
intervention type: Procedure
intervention name: Femoral triangle block
description: 25 milliliters of ropivacaine 0.3% will be injected on the lateral side of the femoral artery at the distal part of the femoral triangle.
arm group label: Arm 1: ITO group
intervention type: Procedure
intervention name: Obturator nerve block
description: 20 milliliters of ropivacaine 0.3% will be injected between the adductor magnus and adductor brevis muscles and between the adductor brevis muscle the pectineus.
arm group label: Arm 1: ITO group
arm group label: Arm 2 : Quadri-block group
intervention type: Procedure
intervention name: Femoral nerve block
description: 20 milliliters of ropivacaine 0.3% will be injected in supine position under the fascia iliaca lateral to the femoral artery.
arm group label: Arm 2 : Quadri-block group
intervention type: Procedure
intervention name: Sciatic nerve block
description: 25 milliliters of ropivacaine 0.3% will be injected in prone position in the subgluteal space by lateral approach.
arm group label: Arm 2 : Quadri-block group
intervention type: Procedure
intervention name: Lateral femoral cutaneous nerve block
description: 5 milliliters of ropivacaine 0.3% will be injected laterally to the sartorius muscle.
arm group label: Arm 2 : Quadri-block group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No