<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/NCT02197273</url>
  </required_header>
  <id_info>
    <org_study_id>OH1-14-00529</org_study_id>
    <nct_id>NCT02197273</nct_id>
  </id_info>
  <brief_title>Liposomal Bupivacaine Versus Standard Analgesia in Total Joint Arthroplasty (TJA)</brief_title>
  <official_title>Efficacy of Liposomal Bupivacaine Versus Standard Analgesia in Pain Management of Total Joint Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>OhioHealth</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>OhioHealth</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether liposomal bupivacaine is effective in the&#xD;
      management of pain following total joint arthroplasty, as compared to standard of care&#xD;
      analgesia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Liposomal bupivacaine (Exparel®) is a local anesthetic made up of liposomal encapsulated&#xD;
      bupivacaine. It is designed to be injected at the time of surgery into the local soft&#xD;
      tissues. Because of its unique liposomal delivery system, Liposomal bupivacaine (Exparel®)&#xD;
      has been shown to provide up to 96 hours of pain relief following surgeries. This makes it an&#xD;
      attractive option in total joint arthroplasty patients. Combined with the proven efficacy of&#xD;
      regional anesthesia, intraoperative liposomal bupivacaine (Exparel®) may provide extended&#xD;
      pain relief following total joint arthroplasty. This has the potential to avoid the need for&#xD;
      opioid medications. With better pain control, medication side effects can be avoided and&#xD;
      patient's length of stay in the hospital can be shortened.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Length of Stay in Hospital (Days)</measure>
    <time_frame>Participants were followed for the duration of hospital stay, an expected average of 3 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time to Post-operative Rescue Opioids (Hours)</measure>
    <time_frame>Immediately following discharge from operating room until the participant was discharged from the hospital, an expected average of 3 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Readmission or Emergency Department (ED) Visit Due to Pain Control Within 30 Days</measure>
    <time_frame>Date of discharge through 30 days following discharge</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">211</enrollment>
  <condition>Osteoarthritis, Knee</condition>
  <condition>Osteoarthritis, Hip</condition>
  <condition>Osteoarthritis, Shoulder</condition>
  <arm_group>
    <arm_group_label>Standard of care analgesia</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Total Hip Arthroplasty (THA):&#xD;
All patients will receive a spinal anesthetic using Fentanyl and Bupivacaine&#xD;
Injection into capsular tissue after placement of the acetabular component:&#xD;
0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline&#xD;
Total Knee Arthroplasty (TKA):&#xD;
All patients will receive a spinal anesthetic using Fentanyl and Bupivacaine All patients will receive an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc&#xD;
Injection into posterior capsule of the knee:&#xD;
0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline&#xD;
Total Shoulder Arthroplasty (TSA):&#xD;
All patients will receive a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Liposomal bupivacaine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>THA:&#xD;
Standard of care analgesia, PLUS 266 mg of liposomal bupivacaine. Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue&#xD;
TKA:&#xD;
Standard of care analgesia, PLUS 266 mg of liposomal bupivacaine. Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue&#xD;
TSA:&#xD;
All patients will receive a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine.&#xD;
Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Liposomal bupivacaine</intervention_name>
    <arm_group_label>Liposomal bupivacaine</arm_group_label>
    <other_name>Exparel</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Standard of care analgesia</intervention_name>
    <arm_group_label>Liposomal bupivacaine</arm_group_label>
    <arm_group_label>Standard of care analgesia</arm_group_label>
    <other_name>Bupivacaine</other_name>
    <other_name>Ropivacaine</other_name>
    <other_name>Fentanyl</other_name>
    <other_name>Solumedrol</other_name>
    <other_name>Morphine</other_name>
    <other_name>Saline</other_name>
    <other_name>Epinephrine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Clinical diagnosis of osteoarthritis&#xD;
&#xD;
          2. Elected to undergo primary TKA, THA, or TSA&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age &lt; 18 years&#xD;
&#xD;
          2. Pregnant or breastfeeding&#xD;
&#xD;
          3. Non-English speaking&#xD;
&#xD;
          4. Unable to give informed consent&#xD;
&#xD;
          5. Previous open hip, knee or shoulder surgery&#xD;
&#xD;
          6. Pre-determined patients discharging to ECF&#xD;
&#xD;
          7. Patients with allergies to bupivacaine&#xD;
&#xD;
          8. Patients currently taking opioid pain medication&#xD;
&#xD;
          9. Patients with contraindication to nerve blocks&#xD;
&#xD;
         10. Patients undergoing simultaneous bilateral joint replacement, as this would require &gt;1&#xD;
             dose of liposomal bupivacaine (Exparel®) per patient for each surgical site&#xD;
&#xD;
         11. Patients with severe hepatic disease&#xD;
&#xD;
         12. Patients with chronic heart disease as defined as a decreased ejection fraction&#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>Deborah Napier, BSN,RN,MA</last_name>
    <role>Principal Investigator</role>
    <affiliation>OhioHealth</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>OhioHealth Riverside Methodist Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43214</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>July 17, 2014</study_first_submitted>
  <study_first_submitted_qc>July 18, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 22, 2014</study_first_posted>
  <results_first_submitted>May 10, 2016</results_first_submitted>
  <results_first_submitted_qc>August 30, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">October 21, 2016</results_first_posted>
  <last_update_submitted>August 30, 2016</last_update_submitted>
  <last_update_submitted_qc>August 30, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 21, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>OhioHealth</investigator_affiliation>
    <investigator_full_name>Deborah Napier</investigator_full_name>
    <investigator_title>Clinical Outcomes Manager</investigator_title>
  </responsible_party>
  <keyword>Total knee arthroplasty</keyword>
  <keyword>Total shoulder arthroplasty</keyword>
  <keyword>Total hip arthroplasty</keyword>
  <keyword>Total joint arthroplasty</keyword>
  <keyword>Hip replacement</keyword>
  <keyword>Knee replacement</keyword>
  <keyword>Shoulder replacement</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Knee</mesh_term>
    <mesh_term>Osteoarthritis, Hip</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methylprednisolone Hemisuccinate</mesh_term>
    <mesh_term>Epinephrine</mesh_term>
    <mesh_term>Fentanyl</mesh_term>
    <mesh_term>Morphine</mesh_term>
    <mesh_term>Bupivacaine</mesh_term>
    <mesh_term>Ropivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment period July 1, 2014 to September 30, 2015 for patients undergoing total hip, knee or shoulder arthroplasty at OhioHealth Riverside Methodist Hospital.</recruitment_details>
      <pre_assignment_details>Patients were randomized in a one to one fashion to one of two study groups within each surgical group. 10 patients were excluded after enrollment due to dual enrollment in another study, changes in anesthesia plan or improper dose of study drug. These 10 patients were not included in the analysis.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Standard of Care Analgesia</title>
          <description>THA:&#xD;
33 patients received a spinal anesthetic using Fentanyl and Bupivacaine&#xD;
Injection into capsular tissue after placement of the acetabular component:&#xD;
0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline&#xD;
TKA:&#xD;
39 patients received a spinal anesthetic using Fentanyl and Bupivacaine 39 patients received an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc&#xD;
Injection into posterior capsule of the knee:&#xD;
0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline&#xD;
TSA:&#xD;
35 patients received a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days.&#xD;
Standard of care analgesia</description>
        </group>
        <group group_id="P2">
          <title>Liposomal Bupivacaine</title>
          <description>THA:&#xD;
36 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.&#xD;
Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue&#xD;
TKA:&#xD;
34 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.&#xD;
Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue&#xD;
TSA:&#xD;
34 patient received a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine.&#xD;
Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle&#xD;
Liposomal bupivacaine&#xD;
Standard of care analgesia</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="107"/>
                <participants group_id="P2" count="104"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="107"/>
                <participants group_id="P2" count="104"/>
              </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>Standard of Care Analgesia</title>
          <description>THA:&#xD;
All patients will receive a spinal anesthetic using Fentanyl and Bupivacaine&#xD;
Injection into capsular tissue after placement of the acetabular component:&#xD;
0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline&#xD;
TKA:&#xD;
All patients will receive a spinal anesthetic using Fentanyl and Bupivacaine All patients will receive an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc&#xD;
Injection into posterior capsule of the knee:&#xD;
0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline&#xD;
TSA:&#xD;
All patients will receive a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days.&#xD;
Standard of care analgesia</description>
        </group>
        <group group_id="B2">
          <title>Liposomal Bupivacaine</title>
          <description>THA:&#xD;
Standard of care analgesia, PLUS 266 mg of liposomal bupivacaine. Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue&#xD;
TKA:&#xD;
Standard of care analgesia, PLUS 266 mg of liposomal bupivacaine. Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue&#xD;
TSA:&#xD;
All patients will receive a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine.&#xD;
Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle&#xD;
Liposomal bupivacaine&#xD;
Standard of care analgesia</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="107"/>
            <count group_id="B2" value="104"/>
            <count group_id="B3" value="211"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="66.5" spread="8.4"/>
                    <measurement group_id="B2" value="65.9" spread="9.1"/>
                    <measurement group_id="B3" value="66.3" spread="8.6"/>
                  </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="57"/>
                    <measurement group_id="B2" value="61"/>
                    <measurement group_id="B3" value="118"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="43"/>
                    <measurement group_id="B3" value="93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Length of Stay in Hospital (Days)</title>
        <time_frame>Participants were followed for the duration of hospital stay, an expected average of 3 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard of Care Analgesia</title>
            <description>THA:&#xD;
33 patients received a spinal anesthetic using Fentanyl and Bupivacaine&#xD;
Injection into capsular tissue after placement of the acetabular component:&#xD;
0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline&#xD;
TKA:&#xD;
39 patients received a spinal anesthetic using Fentanyl and Bupivacaine 39 patients received an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc&#xD;
Injection into posterior capsule of the knee:&#xD;
0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline&#xD;
TSA:&#xD;
35 patients received a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days.&#xD;
Standard of care analgesia</description>
          </group>
          <group group_id="O2">
            <title>Liposomal Bupivacaine</title>
            <description>THA:&#xD;
36 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.&#xD;
Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue&#xD;
TKA:&#xD;
34 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.&#xD;
Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue&#xD;
TSA:&#xD;
34 patient received a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine.&#xD;
Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle&#xD;
Liposomal bupivacaine&#xD;
Standard of care analgesia</description>
          </group>
        </group_list>
        <measure>
          <title>Length of Stay in Hospital (Days)</title>
          <units>days</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="107"/>
                <count group_id="O2" value="104"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" lower_limit="1.0" upper_limit="7.0"/>
                    <measurement group_id="O2" value="2.0" lower_limit="1.0" upper_limit="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.764</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Time to Post-operative Rescue Opioids (Hours)</title>
        <time_frame>Immediately following discharge from operating room until the participant was discharged from the hospital, an expected average of 3 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard of Care Analgesia</title>
            <description>THA:&#xD;
33 patients received a spinal anesthetic using Fentanyl and Bupivacaine&#xD;
Injection into capsular tissue after placement of the acetabular component:&#xD;
0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline&#xD;
TKA:&#xD;
39 patients received a spinal anesthetic using Fentanyl and Bupivacaine 39 patients received an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc&#xD;
Injection into posterior capsule of the knee:&#xD;
0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline&#xD;
TSA:&#xD;
35 patients received a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days.&#xD;
Standard of care analgesia</description>
          </group>
          <group group_id="O2">
            <title>Liposomal Bupivacaine</title>
            <description>THA:&#xD;
36 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.&#xD;
Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue&#xD;
TKA:&#xD;
34 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.&#xD;
Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue&#xD;
TSA:&#xD;
34 patient received a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine.&#xD;
Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle&#xD;
Liposomal bupivacaine&#xD;
Standard of care analgesia</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Post-operative Rescue Opioids (Hours)</title>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="107"/>
                <count group_id="O2" value="104"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.7" lower_limit="2.6" upper_limit="49.5"/>
                    <measurement group_id="O2" value="11.8" lower_limit="2.2" upper_limit="75.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.206</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Readmission or Emergency Department (ED) Visit Due to Pain Control Within 30 Days</title>
        <time_frame>Date of discharge through 30 days following discharge</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Standard of Care Analgesia</title>
            <description>THA:&#xD;
33 patients received a spinal anesthetic using Fentanyl and Bupivacaine&#xD;
Injection into capsular tissue after placement of the acetabular component:&#xD;
0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline&#xD;
TKA:&#xD;
39 patients received a spinal anesthetic using Fentanyl and Bupivacaine 39 patients received an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc&#xD;
Injection into posterior capsule of the knee:&#xD;
0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline&#xD;
TSA:&#xD;
35 patients received a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days.&#xD;
Standard of care analgesia</description>
          </group>
          <group group_id="O2">
            <title>Liposomal Bupivacaine</title>
            <description>THA:&#xD;
36 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.&#xD;
Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue&#xD;
TKA:&#xD;
34 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.&#xD;
Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue&#xD;
TSA:&#xD;
34 patient received a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine.&#xD;
Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle&#xD;
Liposomal bupivacaine&#xD;
Standard of care analgesia</description>
          </group>
        </group_list>
        <measure>
          <title>Readmission or Emergency Department (ED) Visit Due to Pain Control Within 30 Days</title>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="107"/>
                <count group_id="O2" value="104"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority or Other</non_inferiority_type>
            <p_value>0.656</p_value>
            <method>Fisher Exact</method>
            <param_type>Fisher exact</param_type>
            <param_value>0.486</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Standard of Care Analgesia</title>
          <description>THA:&#xD;
33 patients received a spinal anesthetic using Fentanyl and Bupivacaine&#xD;
Injection into capsular tissue after placement of the acetabular component:&#xD;
0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline&#xD;
TKA:&#xD;
39 patients received a spinal anesthetic using Fentanyl and Bupivacaine 39 patients received an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc&#xD;
Injection into posterior capsule of the knee:&#xD;
0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline&#xD;
TSA:&#xD;
35 patients received a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days.&#xD;
Standard of care analgesia</description>
        </group>
        <group group_id="E2">
          <title>Liposomal Bupivacaine</title>
          <description>THA:&#xD;
36 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.&#xD;
Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue&#xD;
TKA:&#xD;
33 patients received the standard of care analgesia, PLUS 266 mg of liposomal bupivacaine.&#xD;
Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue&#xD;
TSA:&#xD;
34 patient received a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine.&#xD;
Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle&#xD;
Liposomal bupivacaine&#xD;
Standard of care analgesia</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="107"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="104"/>
              </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="107"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="104"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>knee pain</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="107"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="104"/>
              </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>No early termination or technical problems identified.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Deborah Napier</name_or_title>
      <organization>OhioHealth</organization>
      <phone>614-566-5575</phone>
      <email>Deborah.Napier@ohiohealth.com</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/NCT02197273
org study id: OH1-14-00529
nct id: NCT02197273
lead sponsor: 
has dmc: No
The purpose of this study is to determine whether liposomal bupivacaine is effective in the
      management of pain following total joint arthroplasty, as compared to standard of care
      analgesia.
Liposomal bupivacaine (Exparel®) is a local anesthetic made up of liposomal encapsulated
      bupivacaine. It is designed to be injected at the time of surgery into the local soft
      tissues. Because of its unique liposomal delivery system, Liposomal bupivacaine (Exparel®)
      has been shown to provide up to 96 hours of pain relief following surgeries. This makes it an
      attractive option in total joint arthroplasty patients. Combined with the proven efficacy of
      regional anesthesia, intraoperative liposomal bupivacaine (Exparel®) may provide extended
      pain relief following total joint arthroplasty. This has the potential to avoid the need for
      opioid medications. With better pain control, medication side effects can be avoided and
      patient's length of stay in the hospital can be shortened.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Length of Stay in Hospital (Days)
time frame: Participants were followed for the duration of hospital stay, an expected average of 3 days
measure: Time to Post-operative Rescue Opioids (Hours)
time frame: Immediately following discharge from operating room until the participant was discharged from the hospital, an expected average of 3 days
measure: Readmission or Emergency Department (ED) Visit Due to Pain Control Within 30 Days
time frame: Date of discharge through 30 days following discharge
arm group label: Standard of care analgesia
arm group type: Active Comparator
description: Total Hip Arthroplasty (THA):
All patients will receive a spinal anesthetic using Fentanyl and Bupivacaine
Injection into capsular tissue after placement of the acetabular component:
0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline
Total Knee Arthroplasty (TKA):
All patients will receive a spinal anesthetic using Fentanyl and Bupivacaine All patients will receive an adductor canal block of 0.25% Bupivacaine w/epinephrine 30cc
Injection into posterior capsule of the knee:
0.5% Bupivacaine 15 cc 40 mg Solumedrol 10 mg Morphine 20 cc Saline
Total Shoulder Arthroplasty (TSA):
All patients will receive a standard interscalene block with bupivacaine followed by indwelling catheter insertion with ropivacaine infusion to be left in place for two days.
arm group label: Liposomal bupivacaine
arm group type: Experimental
description: THA:
Standard of care analgesia, PLUS 266 mg of liposomal bupivacaine. Anterior capsule Inferior capsule Posterior capsule Short external rotator Gluteus maximus Subcutaneous tissue
TKA:
Standard of care analgesia, PLUS 266 mg of liposomal bupivacaine. Posterior knee capsule Anterior femoral periosteum Anterior tibial periosteum Subcutaneous tissue Pericapsular meniscal tissue
TSA:
All patients will receive a standard interscalene block with bupivacaine PLUS 266 mg of liposomal bupivacaine.
Posterior capsule Rotator cuff Subscapularis Humeral periosteum Subcutaneous tissue Deltopectoral muscle
intervention type: Drug
intervention name: Liposomal bupivacaine
arm group label: Liposomal bupivacaine
other name: Exparel
intervention type: Drug
intervention name: Standard of care analgesia
arm group label: Liposomal bupivacaine
arm group label: Standard of care analgesia
other name: Bupivacaine
other name: Ropivacaine
other name: Fentanyl
other name: Solumedrol
other name: Morphine
other name: Saline
other name: Epinephrine
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Deborah Napier, BSN,RN,MA
role: Principal Investigator
affiliation: OhioHealth
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: OhioHealth
investigator full name: Deborah Napier
investigator title: Clinical Outcomes Manager
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Knee
mesh term: Osteoarthritis, Hip
mesh term: Methylprednisolone Hemisuccinate
mesh term: Epinephrine
mesh term: Fentanyl
mesh term: Morphine
mesh term: Bupivacaine
mesh term: Ropivacaine
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: No early termination or technical problems identified.
point of contact: 