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/NCT06006624</url>
    </required_header>
    <id_info>
      <org_study_id>SHAM2023-2163</org_study_id>
      <nct_id>NCT06006624</nct_id>
    </id_info>
    <brief_title>Exparel vs Block for ACL Reconstruction</brief_title>
    <official_title>Single-Shot Liposomal Bupivacaine vs. Liposomal Bupivacaine Combined With Dexamethasone Following Anterior Cruciate Ligament Reconstruction: A Prospective Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Rothman Institute Orthopaedics</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Rothman Institute Orthopaedics</source>
    <oversight_info>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Liposomal bupivacaine or Exparel (Pacira Biosciences) is a long-lasting nonopioid analgesic&#xD;
        that was initially utilized as an infiltrative agent but has more recently become U.S. Food&#xD;
        and Drug Administration (FDA) approved for use in interscalene brachial plexus nerve blockade&#xD;
        as well as infiltrative blockade. Delivery in this form is reported to provide up to 72 hours&#xD;
        of extended-release bupivacaine. Exparel's use as a regional anesthetic has also become&#xD;
        increasingly common and has shown promise when utilized in Anterior Cruciate Ligament (ACL)&#xD;
        reconstruction.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Anticipated">August 21, 2023</start_date>
    <completion_date type="Anticipated">October 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 30, 2024</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>Double (Participant, Care Provider)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Postoperative Pain</measure>
      <time_frame>14 days</time_frame>
      <description>Daily postoperative VAS (visual analog scale for pain) scale will be collected from participants to assess pain</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Postoperative opioid use</measure>
      <time_frame>14 days</time_frame>
      <description>assessed using a participant daily diary of how much medication was taken daily for pain</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Postoperative Pain #2</measure>
      <time_frame>14 days</time_frame>
      <description>Daily postoperative NRS (numerical rating scale for pain) scale will be collected from participants to assess pain</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">154</enrollment>
    <condition>ACL</condition>
    <condition>Postoperative Pain</condition>
    <arm_group>
      <arm_group_label>Group 1: ACL repair + Exparel + nerve block</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>30 mL Liposomal bupivacaine (Exparel) + 5 cc's of 0.5% bupivacaine evenly distributed and administered in adductor canal and iPACK block (35 mL total)</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group 2: ACL repair + Exparel + Dexamethasone + nerve block</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>30 mL Liposomal bupivacaine (Exparel) + 10 mg preservative free Dexamethasone + 5 cc's of 0.5% bupivacaine evenly distributed for both adductor canal and iPACK block (35 mL total)</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Exparel 30 mL</intervention_name>
      <description>30 mL Liposomal bupivacaine (Exparel) evenly distributed and administered in adductor canal block</description>
      <arm_group_label>Group 1: ACL repair + Exparel + nerve block</arm_group_label>
      <arm_group_label>Group 2: ACL repair + Exparel + Dexamethasone + nerve block</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>0.5% bupivacaine</intervention_name>
      <description>5 cc's of 0.5% bupivacaine evenly distributed and administered in adductor canal</description>
      <arm_group_label>Group 1: ACL repair + Exparel + nerve block</arm_group_label>
      <arm_group_label>Group 2: ACL repair + Exparel + Dexamethasone + nerve block</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Dexamethasone</intervention_name>
      <description>10 mg preservative free Dexamethasone evenly distributed and administered in adductor canal</description>
      <arm_group_label>Group 2: ACL repair + Exparel + Dexamethasone + nerve block</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>iPACK block</intervention_name>
      <description>iPACK (Infiltration between the Popliteal artery and Capsule of the Knee) block</description>
      <arm_group_label>Group 1: ACL repair + Exparel + nerve block</arm_group_label>
      <arm_group_label>Group 2: ACL repair + Exparel + Dexamethasone + nerve block</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Paticipants with ACL rupture amenable to reconstruction with BTB autograft identified&#xD;
               in clinic by one of 4 different surgeons&#xD;
  &#xD;
            -  Primary ACL Reconstruction with Autograft +/- Partial meniscectomy +/- Lateral&#xD;
               extra-articular tenodesis&#xD;
  &#xD;
            -  Age 18 and older&#xD;
  &#xD;
            -  English speaking&#xD;
  &#xD;
            -  Ability to complete surveys by phone or in person&#xD;
  &#xD;
            -  Ability to provide informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Revision cases&#xD;
  &#xD;
            -  Multi-ligamentous knee injuries&#xD;
  &#xD;
            -  Cartilage or meniscal procedures that prevent adherence to immediate weight bearing&#xD;
               and range of motion rehab protocol&#xD;
  &#xD;
            -  ACL reconstruction utilizing non-bone-patellar tendon-bone autografts&#xD;
  &#xD;
            -  Allergies to study medications&#xD;
  &#xD;
            -  Non-English speakers&#xD;
  &#xD;
            -  Known alcohol or narcotic abuse history&#xD;
  &#xD;
            -  Existing contract with a pain specialist due to underlying preoperative pain syndrome&#xD;
  &#xD;
            -  Preoperative opioid use within the 3 months prior to surgery&#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>
    <location>
      <facility>
        <name>Rothman Orthopaedic Institute</name>
        <address>
          <city>Philadelphia</city>
          <state>Pennsylvania</state>
          <zip>19107</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 17, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <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>Dexamethasone</mesh_term>
      <mesh_term>Bupivacaine</mesh_term>
    </intervention_browse>
    <!-- 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/NCT06006624
  org study id: SHAM2023-2163
  nct id: NCT06006624
  lead sponsor: 
  is fda regulated drug: Yes
  is fda regulated device: No
  is us export: No
  Liposomal bupivacaine or Exparel (Pacira Biosciences) is a long-lasting nonopioid analgesic
        that was initially utilized as an infiltrative agent but has more recently become U.S. Food
        and Drug Administration (FDA) approved for use in interscalene brachial plexus nerve blockade
        as well as infiltrative blockade. Delivery in this form is reported to provide up to 72 hours
        of extended-release bupivacaine. Exparel's use as a regional anesthetic has also become
        increasingly common and has shown promise when utilized in Anterior Cruciate Ligament (ACL)
        reconstruction.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Care Provider)
  measure: Postoperative Pain
  time frame: 14 days
  description: Daily postoperative VAS (visual analog scale for pain) scale will be collected from participants to assess pain
  measure: Postoperative opioid use
  time frame: 14 days
  description: assessed using a participant daily diary of how much medication was taken daily for pain
  measure: Postoperative Pain #2
  time frame: 14 days
  description: Daily postoperative NRS (numerical rating scale for pain) scale will be collected from participants to assess pain
  arm group label: Group 1: ACL repair + Exparel + nerve block
  arm group type: Active Comparator
  description: 30 mL Liposomal bupivacaine (Exparel) + 5 cc's of 0.5% bupivacaine evenly distributed and administered in adductor canal and iPACK block (35 mL total)
  arm group label: Group 2: ACL repair + Exparel + Dexamethasone + nerve block
  arm group type: Active Comparator
  description: 30 mL Liposomal bupivacaine (Exparel) + 10 mg preservative free Dexamethasone + 5 cc's of 0.5% bupivacaine evenly distributed for both adductor canal and iPACK block (35 mL total)
  intervention type: Drug
  intervention name: Exparel 30 mL
  description: 30 mL Liposomal bupivacaine (Exparel) evenly distributed and administered in adductor canal block
  arm group label: Group 1: ACL repair + Exparel + nerve block
  arm group label: Group 2: ACL repair + Exparel + Dexamethasone + nerve block
  intervention type: Drug
  intervention name: 0.5% bupivacaine
  description: 5 cc's of 0.5% bupivacaine evenly distributed and administered in adductor canal
  arm group label: Group 1: ACL repair + Exparel + nerve block
  arm group label: Group 2: ACL repair + Exparel + Dexamethasone + nerve block
  intervention type: Drug
  intervention name: Dexamethasone
  description: 10 mg preservative free Dexamethasone evenly distributed and administered in adductor canal
  arm group label: Group 2: ACL repair + Exparel + Dexamethasone + nerve block
  intervention type: Drug
  intervention name: iPACK block
  description: iPACK (Infiltration between the Popliteal artery and Capsule of the Knee) block
  arm group label: Group 1: ACL repair + Exparel + nerve block
  arm group label: Group 2: ACL repair + Exparel + Dexamethasone + nerve block
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Pain, Postoperative
  mesh term: Dexamethasone
  mesh term: Bupivacaine