xml: <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/NCT06002217</url>
    </required_header>
    <id_info>
      <org_study_id>2022-A00970-43</org_study_id>
      <nct_id>NCT06002217</nct_id>
    </id_info>
    <brief_title>Echo-guided Transverse Abdominal Plane Block (TAP) in Anterior Lumbar Arthrodesis (ALIF)</brief_title>
    <acronym>TAP ALIF</acronym>
    <official_title>Echo-guided Transverse Abdominal Plane Block (TAP) in Anterior Lumbar Arthrodesis (ALIF): Randomized, Double-blind, Controlled Trial.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Clinique Saint Jean, France</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Clinique Saint Jean, France</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>
        The goal of this interventional study is to is to compare the effect of a tap block versus a&#xD;
        placebo in patients undergoing anterior lumbar spine surgery.&#xD;
  &#xD;
        The main question it aims to answer :&#xD;
  &#xD;
        • whether tap block can reduce the need for postoperative pain medication Participants will&#xD;
        be randomized into two groups and all postoperative pain medication will be recorded over 3&#xD;
        days.&#xD;
  &#xD;
        Researchers will compare tap block vs placebo to see if it reduces postoperative pain.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 22, 2023</start_date>
    <completion_date type="Anticipated">February 28, 2024</completion_date>
    <primary_completion_date type="Anticipated">February 28, 2024</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>Treatment</primary_purpose>
      <masking>Triple (Participant, Care Provider, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Analgesic consumption</measure>
      <time_frame>72hours</time_frame>
      <description>The use of analgesics (oral or venous) during the during the 72 hours following surgery</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Pain assessment will be reported for 72 hours after surgery measured on a Visual analogue scale between 0 and 10</measure>
      <time_frame>72hours</time_frame>
      <description>Pain assessment for 72 hours after surgery, measured on a scale between 0 and 10 (VAS scale ), where 0 is no pain and 10 is maximum pain</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">80</enrollment>
    <condition>Fusion of Spine, Lumbar Region</condition>
    <arm_group>
      <arm_group_label>TAP Block</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>saline solution</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Levobupivacaine</intervention_name>
      <description>Patients in the tap block arm will receive an injection of levobupivacaine 2.5mg/ml</description>
      <arm_group_label>TAP Block</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Placebo Tap block</intervention_name>
      <description>Patients in the placebo arm will receive an injection of salin solution 2.5mg/ml , in the same way as tap block</description>
      <arm_group_label>saline solution</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Patient affiliated or entitled to a social security plan.&#xD;
  &#xD;
            -  Patient who has been informed about the study and has co-signed a consent form with&#xD;
               the investigator. consent to participate in the study.&#xD;
  &#xD;
            -  Patients over 18 years of age scheduled for abdominal disc surgery on one or two&#xD;
               levels.&#xD;
  &#xD;
            -  Patient with ASA criteria 1, 2 and 3.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with intolerance or contraindication to paracetamol, anti-inflammatory or&#xD;
               morphine.&#xD;
  &#xD;
            -  Patients allergic to local anesthetics.&#xD;
  &#xD;
            -  Pregnant or breast-feeding patient.&#xD;
  &#xD;
            -  patient undergoing cancer or trauma surgery trauma.&#xD;
  &#xD;
            -  Patient participating in another interventional study.&#xD;
  &#xD;
            -  Patient with a history of lumbar arthrodesis.&#xD;
  &#xD;
            -  Patient refusing to sign consent form.&#xD;
  &#xD;
            -  Patient unable to give informed consent.&#xD;
  &#xD;
            -  Patient under court protection, guardianship or trusteeship.&#xD;
  &#xD;
            -  Patient not available for study follow-up.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 16, 2023</last_update_submitted>
    <last_update_submitted_qc>August 16, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Clinique Saint Jean, France</investigator_affiliation>
      <investigator_full_name>Guillaume LONJON</investigator_full_name>
      <investigator_title>Principal investigator</investigator_title>
    </responsible_party>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Levobupivacaine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06002217
  org study id: 2022-A00970-43
  nct id: NCT06002217
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this interventional study is to is to compare the effect of a tap block versus a
        placebo in patients undergoing anterior lumbar spine surgery.
  
        The main question it aims to answer :
  
        • whether tap block can reduce the need for postoperative pain medication Participants will
        be randomized into two groups and all postoperative pain medication will be recorded over 3
        days.
  
        Researchers will compare tap block vs placebo to see if it reduces postoperative pain.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Investigator)
  measure: Analgesic consumption
  time frame: 72hours
  description: The use of analgesics (oral or venous) during the during the 72 hours following surgery
  measure: Pain assessment will be reported for 72 hours after surgery measured on a Visual analogue scale between 0 and 10
  time frame: 72hours
  description: Pain assessment for 72 hours after surgery, measured on a scale between 0 and 10 (VAS scale ), where 0 is no pain and 10 is maximum pain
  arm group label: TAP Block
  arm group type: Active Comparator
  arm group label: saline solution
  arm group type: Placebo Comparator
  intervention type: Drug
  intervention name: Levobupivacaine
  description: Patients in the tap block arm will receive an injection of levobupivacaine 2.5mg/ml
  arm group label: TAP Block
  intervention type: Other
  intervention name: Placebo Tap block
  description: Patients in the placebo arm will receive an injection of salin solution 2.5mg/ml , in the same way as tap block
  arm group label: saline solution
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  responsible party type: Principal Investigator
  investigator affiliation: Clinique Saint Jean, France
  investigator full name: Guillaume LONJON
  investigator title: Principal investigator
  mesh term: Levobupivacaine
  sharing ipd: No