<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/NCT02189317</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00073168</org_study_id>
    <nct_id>NCT02189317</nct_id>
  </id_info>
  <brief_title>Liposomal Bupivacaine for Pain Control Following Anterior Cruciate Ligament Reconstruction</brief_title>
  <official_title>Liposomal Bupivacaine for Pain Control Following Anterior Cruciate Ligament Reconstruction</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Emory University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will consist of 80 patients ages 18 to 50 at the Emory Orthopaedic and Spine&#xD;
      Center who are undergoing Anterior Cruciate Ligament (ACL) reconstruction with a quadriceps&#xD;
      tendon autograft or bone patellar tendon bone autograft by Dr. Karas or Dr. Xerogeanes.&#xD;
      Patients will be randomized into treatment and control arms. The treatment arm will include&#xD;
      40 patients receiving liposomal bupivacaine intra-operatively in addition to the current&#xD;
      standard pain control regimen. The control group will include 40 patients receiving the&#xD;
      standard post-operative pain control regimen. Patients will be assessed to identify&#xD;
      differences in post-operative pain, satisfaction, as well as concomitant pain medication use.&#xD;
      Post-operative range of motion will also be assessed.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 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>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Numerical Rating Scale (NRS) Pain Score</measure>
    <time_frame>Day of Surgery, Post-Operative Day 6 (Up to 144 hours)</time_frame>
    <description>The numerical rating scale (NRS) pain score is a self-reported pain scale from 0 to 10 where zero is equal to &quot;no pain&quot; and ten is equal to &quot;worst possible&quot; pain. The score was recorded every 12 hours for up to 144 hours (six days) post-operatively.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Home Opioid Use</measure>
    <time_frame>Day of Surgery, Post-Operative Day 6 (Up to 144 hours)</time_frame>
    <description>The difference in amount of Percocet (7.5/325 tablets) usage post-surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in Time to First Opioid Use</measure>
    <time_frame>Day of Surgery, Post-Operative Day 6 (Up to 144 hours)</time_frame>
    <description>The time difference in hours to first Percocet (7.5/325 tablets) usage post-surgery.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Anterior Cruciate Ligament Rupture</condition>
  <arm_group>
    <arm_group_label>Exparel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This arm will receive Exparel</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Exparel</intervention_name>
    <description>For the treatment group a total of 40 cc consisting of 20 cc of 1.3% Exparel® and 20 cc of 0.5 % marcaine will be administered to the ACL harvest site, into the periosteum surrounding the distal tibial tunnel site, and in the proximity of the skin incisions. No infiltration of Exparel will be provided intra-articularly.</description>
    <arm_group_label>Exparel</arm_group_label>
    <other_name>Liposomal Bupivacaine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Ages between 18 and 50 chronological years undergoing ACL reconstruction using a&#xD;
             quadriceps tendon or BTB autograft.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with known allergies to local anesthetics&#xD;
&#xD;
          -  pregnant patients&#xD;
&#xD;
          -  patients with a history of liver disease&#xD;
&#xD;
          -  patients undergoing bilateral procedures&#xD;
&#xD;
          -  Patients undergoing revision ACL surgery and patients undergoing ACL reconstruction&#xD;
             using pediatric physeal sparing techniques&#xD;
&#xD;
          -  Patients will also be excluded if any clinically significant event or condition is&#xD;
             discovered during the time of, or after surgery that may render them medically&#xD;
             unstable, or subject them to a surgical complication.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John Xerogeanes, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emory University Orthopaedic and Spine Center</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30324</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>June 2016</verification_date>
  <study_first_submitted>July 10, 2014</study_first_submitted>
  <study_first_submitted_qc>July 11, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 14, 2014</study_first_posted>
  <results_first_submitted>May 7, 2016</results_first_submitted>
  <results_first_submitted_qc>May 7, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">June 14, 2016</results_first_posted>
  <last_update_submitted>June 28, 2016</last_update_submitted>
  <last_update_submitted_qc>June 28, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 27, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>John Xerogeanes</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rupture</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Participants were recruited from an ambulatory surgery center from July 2014 to March 2015.</recruitment_details>
      <pre_assignment_details>Of the fifty participants who consented for the study, 18 participants who had different graph types were excluded to avoid a potential confounder. Thirty two participants were included in the overall study who had identical graph types.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Bupivacaine HCl</title>
          <description>Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received 20 mL 0.25% bupivacaine HCl and 20 ml 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.</description>
        </group>
        <group group_id="P2">
          <title>Exparel (Bupivacaine Liposome)</title>
          <description>Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received a 40-mL suspension of 20 mL Exparel (1 vial of bupivacaine liposome injectable suspension) and 20 mL 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="16"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Bupivacaine HCl</title>
          <description>Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received 20 mL 0.25% bupivacaine HCl and 20 ml 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.</description>
        </group>
        <group group_id="B2">
          <title>Exparel (Liposomal Bupivacaine)</title>
          <description>Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received a 40-mL suspension of 20 mL Exparel (1 vial of bupivacaine liposome injectable suspension) and 20 mL 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="16"/>
            <count group_id="B2" value="16"/>
            <count group_id="B3" value="32"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Numerical Rating Scale (NRS) Pain Score</title>
        <description>The numerical rating scale (NRS) pain score is a self-reported pain scale from 0 to 10 where zero is equal to &quot;no pain&quot; and ten is equal to &quot;worst possible&quot; pain. The score was recorded every 12 hours for up to 144 hours (six days) post-operatively.</description>
        <time_frame>Day of Surgery, Post-Operative Day 6 (Up to 144 hours)</time_frame>
        <population>Participants who underwent ACL reconstruction surgery and returned a completed post-operative pain and medication journal (bupivacaine HCl group).&#xD;
Participants who underwent ACL reconstruction surgery, returned a completed post-operative pain and medication journal, and did not require reoperation (Exparel liposomal/bupivacaine group).</population>
        <group_list>
          <group group_id="O1">
            <title>Bupivacaine HCl</title>
            <description>Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received 20 mL 0.25% bupivacaine HCl and 20 ml 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.</description>
          </group>
          <group group_id="O2">
            <title>Exparel (Liposomal Bupivacaine)</title>
            <description>Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received a 40-mL suspension of 20 mL Exparel (1 vial of bupivacaine liposome injectable suspension) and 20 mL 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Numerical Rating Scale (NRS) Pain Score</title>
          <description>The numerical rating scale (NRS) pain score is a self-reported pain scale from 0 to 10 where zero is equal to &quot;no pain&quot; and ten is equal to &quot;worst possible&quot; pain. The score was recorded every 12 hours for up to 144 hours (six days) post-operatively.</description>
          <population>Participants who underwent ACL reconstruction surgery and returned a completed post-operative pain and medication journal (bupivacaine HCl group).&#xD;
Participants who underwent ACL reconstruction surgery, returned a completed post-operative pain and medication journal, and did not require reoperation (Exparel liposomal/bupivacaine group).</population>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline (recovery room)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" spread="2.1"/>
                    <measurement group_id="O2" value="4.7" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Evening on the day of surgery</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0" spread="3.7"/>
                    <measurement group_id="O2" value="4.1" spread="2.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1 Morning</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.7" spread="2.5"/>
                    <measurement group_id="O2" value="4.5" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 1 Evening</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.2" spread="2.6"/>
                    <measurement group_id="O2" value="5.6" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 2 Morning</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.1" spread="2.6"/>
                    <measurement group_id="O2" value="4.9" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 2 Evening</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.1" spread="2.4"/>
                    <measurement group_id="O2" value="4.7" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3 Morning</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.7" spread="2.5"/>
                    <measurement group_id="O2" value="4.8" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 3 Evening</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6" spread="2.5"/>
                    <measurement group_id="O2" value="4.5" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 4 Morning</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" spread="2.2"/>
                    <measurement group_id="O2" value="4.1" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 4 Evening</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" spread="2.0"/>
                    <measurement group_id="O2" value="3.6" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 5 Morning</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" spread="2.1"/>
                    <measurement group_id="O2" value="2.8" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 5 Evening</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" spread="2.1"/>
                    <measurement group_id="O2" value="2.5" spread="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 6 Morning</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" spread="2.2"/>
                    <measurement group_id="O2" value="2.5" spread="2.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 6 Evening</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" spread="2.3"/>
                    <measurement group_id="O2" value="1.4" spread="2.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in Home Opioid Use</title>
        <description>The difference in amount of Percocet (7.5/325 tablets) usage post-surgery.</description>
        <time_frame>Day of Surgery, Post-Operative Day 6 (Up to 144 hours)</time_frame>
        <population>Participants who underwent ACL reconstruction surgery and returned a completed post-operative pain and medication journal (bupivacaine HCl group).&#xD;
Participants who underwent ACL reconstruction surgery, returned a completed post-operative pain and medication journal, and did not require reoperation (Exparel liposomal/bupivacaine group).</population>
        <group_list>
          <group group_id="O1">
            <title>Bupivacaine HCl</title>
            <description>Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received 20 mL 0.25% bupivacaine HCl and 20 ml 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.</description>
          </group>
          <group group_id="O2">
            <title>Exparel (Liposomal Bupivacaine)</title>
            <description>Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received a 40-mL suspension of 20 mL Exparel (1 vial of bupivacaine liposome injectable suspension) and 20 mL 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Home Opioid Use</title>
          <description>The difference in amount of Percocet (7.5/325 tablets) usage post-surgery.</description>
          <population>Participants who underwent ACL reconstruction surgery and returned a completed post-operative pain and medication journal (bupivacaine HCl group).&#xD;
Participants who underwent ACL reconstruction surgery, returned a completed post-operative pain and medication journal, and did not require reoperation (Exparel liposomal/bupivacaine group).</population>
          <units>miligrams</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Up to 72 hours</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10.2" spread="4.8"/>
                    <measurement group_id="O2" value="9.3" spread="6.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day of Surgery</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" spread="1.3"/>
                    <measurement group_id="O2" value="2.5" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Postoperative Day 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.9" spread="2.9"/>
                    <measurement group_id="O2" value="4.1" spread="3.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Postoperative Day 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" spread="2.1"/>
                    <measurement group_id="O2" value="2.3" spread="2.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Postoperative Day 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.3" spread="1.9"/>
                    <measurement group_id="O2" value="1.3" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Postoperative Day 4</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7" spread="1.4"/>
                    <measurement group_id="O2" value="0.8" spread="1.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Postoperative Day 5</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" spread="1.5"/>
                    <measurement group_id="O2" value="0.2" spread="0.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Postoperative Day 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.6" spread="1.6"/>
                    <measurement group_id="O2" value="0.3" spread="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Difference in Time to First Opioid Use</title>
        <description>The time difference in hours to first Percocet (7.5/325 tablets) usage post-surgery.</description>
        <time_frame>Day of Surgery, Post-Operative Day 6 (Up to 144 hours)</time_frame>
        <population>Participants who underwent ACL reconstruction surgery and returned a completed post-operative pain and medication journal (bupivacaine HCl group).&#xD;
Participants who underwent ACL reconstruction surgery, returned a completed post-operative pain and medication journal, and did not require reoperation (Exparel liposomal/bupivacaine group).</population>
        <group_list>
          <group group_id="O1">
            <title>Bupivacaine HCl</title>
            <description>Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received 20 mL 0.25% bupivacaine HCl and 20 ml 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.</description>
          </group>
          <group group_id="O2">
            <title>Exparel (Liposomal Bupivacaine)</title>
            <description>Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received a 40-mL suspension of 20 mL Exparel (1 vial of bupivacaine liposome injectable suspension) and 20 mL 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.</description>
          </group>
        </group_list>
        <measure>
          <title>Difference in Time to First Opioid Use</title>
          <description>The time difference in hours to first Percocet (7.5/325 tablets) usage post-surgery.</description>
          <population>Participants who underwent ACL reconstruction surgery and returned a completed post-operative pain and medication journal (bupivacaine HCl group).&#xD;
Participants who underwent ACL reconstruction surgery, returned a completed post-operative pain and medication journal, and did not require reoperation (Exparel liposomal/bupivacaine group).</population>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="14"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.2" spread="2.1"/>
                    <measurement group_id="O2" value="3.1" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Bupivacaine HCl</title>
          <description>Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received 20 mL 0.25% bupivacaine HCl and 20 ml 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.</description>
        </group>
        <group group_id="E2">
          <title>Exparel (Bupivacaine Liposome)</title>
          <description>Participants undergoing primary anterior cruciate ligament (ACL) reconstruction with a soft tissue quadriceps tendon autograft received a femoral block immediately before surgery. Participants then received a 40-mL suspension of 20 mL Exparel (1 vial of bupivacaine liposome injectable suspension) and 20 mL 0.9% injectable saline administered into the graft harvest site and portal sites during surgery.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Post-operative Hematoma</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="16"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="16"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>The study lacked a third comparison group of participants who received placebo which may have provided another internal control. Additionally, there was a difference in the total milligrams of bupivacaine administered in each study group.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>John W Xerogeanes, MD</name_or_title>
      <organization>Emory University</organization>
      <phone>404-778-7202</phone>
      <email>jxeroge@emory.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02189317
org study id: IRB00073168
nct id: NCT02189317
lead sponsor: 
has dmc: No
This study will consist of 80 patients ages 18 to 50 at the Emory Orthopaedic and Spine
      Center who are undergoing Anterior Cruciate Ligament (ACL) reconstruction with a quadriceps
      tendon autograft or bone patellar tendon bone autograft by Dr. Karas or Dr. Xerogeanes.
      Patients will be randomized into treatment and control arms. The treatment arm will include
      40 patients receiving liposomal bupivacaine intra-operatively in addition to the current
      standard pain control regimen. The control group will include 40 patients receiving the
      standard post-operative pain control regimen. Patients will be assessed to identify
      differences in post-operative pain, satisfaction, as well as concomitant pain medication use.
      Post-operative range of motion will also be assessed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Change in Numerical Rating Scale (NRS) Pain Score
time frame: Day of Surgery, Post-Operative Day 6 (Up to 144 hours)
description: The numerical rating scale (NRS) pain score is a self-reported pain scale from 0 to 10 where zero is equal to "no pain" and ten is equal to "worst possible" pain. The score was recorded every 12 hours for up to 144 hours (six days) post-operatively.
measure: Change in Home Opioid Use
time frame: Day of Surgery, Post-Operative Day 6 (Up to 144 hours)
description: The difference in amount of Percocet (7.5/325 tablets) usage post-surgery.
measure: Difference in Time to First Opioid Use
time frame: Day of Surgery, Post-Operative Day 6 (Up to 144 hours)
description: The time difference in hours to first Percocet (7.5/325 tablets) usage post-surgery.
arm group label: Exparel
arm group type: Experimental
description: This arm will receive Exparel
arm group label: Control
arm group type: No Intervention
intervention type: Drug
intervention name: Exparel
description: For the treatment group a total of 40 cc consisting of 20 cc of 1.3% Exparel® and 20 cc of 0.5 % marcaine will be administered to the ACL harvest site, into the periosteum surrounding the distal tibial tunnel site, and in the proximity of the skin incisions. No infiltration of Exparel will be provided intra-articularly.
arm group label: Exparel
other name: Liposomal Bupivacaine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: John Xerogeanes, MD
role: Principal Investigator
affiliation: Emory University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: John Xerogeanes
investigator title: Associate Professor
mesh term: Rupture
mesh term: Bupivacaine
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: The study lacked a third comparison group of participants who received placebo which may have provided another internal control. Additionally, there was a difference in the total milligrams of bupivacaine administered in each study group.
point of contact: 