<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/NCT03289858</url>
  </required_header>
  <id_info>
    <org_study_id>H00013594</org_study_id>
    <nct_id>NCT03289858</nct_id>
  </id_info>
  <brief_title>Randomized Controlled Trial for Exparel Hip Fracture</brief_title>
  <official_title>Does the Use of Liposomal Bupivacaine Decrease Narcotic Requirements in Geriatric Hip Fractures? A Randomized, Double Blinded Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Massachusetts, Worcester</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Orthopaedic Trauma Association</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Kentucky</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Massachusetts, Worcester</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a prospective, randomized study looking at the effect that a long-acting local&#xD;
      anesthetic has on pain control in patients having surgery for hip fractures. The&#xD;
      investigators are conducting the study to see if that reduces the amount of pain medicine&#xD;
      needed after surgery, and if it reduces other medical complications after surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Osteoporotic fragility fractures of the hip are common in the geriatric population, are&#xD;
      increasing in frequency, and represent a growing social and economic burden. Pain control&#xD;
      after surgical treatment is an area of growing interest, as improvement in post-injury pain&#xD;
      is often an important indication for surgical treatment of hip fractures.&#xD;
&#xD;
      Typically a mainstay of post-operative pain control, the use of opiates has come under&#xD;
      increasing scrutiny, as it has been shown to be associated with delirium, respiratory&#xD;
      depression, and even may even lead to addiction or abuse in the medically frail geriatric&#xD;
      population. These concerns have led to efforts to minimize the use of post-operative opiates&#xD;
      in hip fracture patients. In that context, a treatment that could reduce the necessity of&#xD;
      post-op narcotics while still improving pain control would be potentially valuable.&#xD;
&#xD;
      There has been growing interest in the use of long-acting local anesthetics for improving&#xD;
      pain control in orthopaedics, particularly in the elective total joint arthroplasty&#xD;
      population. Studies have shown that arthroplasty patients receiving long-acting local&#xD;
      anesthetics have decreased opiate requirements, reduced length of stay, and lower costs.&#xD;
      Although well-demonstrated in the elective arthroplasty population, the effects of&#xD;
      long-acting local anesthetics have yet to be demonstrated in the hip fracture population.&#xD;
      Given that these fractures frequently occur in medically frail patients with multiple&#xD;
      comorbidities, in whom post-operative confusion and delirium are relatively common, there is&#xD;
      the potential for treatments that decrease opiate requirements to demonstrate substantial&#xD;
      medical and economic benefits.&#xD;
&#xD;
      Exparel (liposomal bupivacaine) and long-acting local anesthetics have been used extensively&#xD;
      in hip replacement surgery and have not been shown to be associated with any increased risks.&#xD;
      In the case of patients with displaced femoral neck fractures treated with arthroplasty, the&#xD;
      surgical techniques are identical to those being used in this study. Exparel has also been&#xD;
      used in trauma surgery as well as foot and ankle surgery without any increased described&#xD;
      risks, although its use explicitly in hip fractures has not been published. However, the PI&#xD;
      has trained in other medical centers where Exparel is routinely used in hip fracture patients&#xD;
      without any identified increased risks or complications, but there is a paucity of data on&#xD;
      this subject, which is the rationale for this study.&#xD;
&#xD;
      The investigators hypothesize that in patients with osteoporotic fragility fractures of the&#xD;
      hip, patients receiving intraoperative long-acting local anesthetics will have decreased pain&#xD;
      and decreased post-operative opiate requirements, leading to less delirium and decreased&#xD;
      hospital resource utilization during their index hospitalization.&#xD;
&#xD;
      The goal is to conduct a multi-center prospective randomized control trial to determine if&#xD;
      liposomal bupivacaine is superior to standard of care by addressing the below separate but&#xD;
      related aims:&#xD;
&#xD;
        1. Determine the effectiveness of Exparel to reduce narcotic requirements and pain post&#xD;
           operatively after hip fracture treatment. Excess narcotic use in the elderly population&#xD;
           is associated with a host of complications often magnified by polypharmacy, including in&#xD;
           hospital delirium, increased length of stay, nausea, constipation, urinary retention,&#xD;
           respiratory depression and others. Decreasing narcotic usage in this group of patients&#xD;
           following hip fracture can possibly reduce such complications. Patients will receive&#xD;
           standard of care medical treatment and be randomized to intra-operative Exparel vs.&#xD;
           placebo injections. Opioid requirements, complications, pain score, and length of stay&#xD;
           will be assessed in the post-operative period. Hypothesis: The investigators hypothesize&#xD;
           that total morphine requirements and pain scores will be decreased in this group&#xD;
           following the administration of exparel in the geriatric hip fracture fracture&#xD;
           population.&#xD;
&#xD;
        2. Determine the effectiveness of Exparel to reduce delirium in post-operative hip fracture&#xD;
           patients. In hospital delirium in elderly patients is associated with poor outcomes,&#xD;
           including prolonged length of stay, poor participation in rehabilitation, and falls. Use&#xD;
           of a locally administered liposomal bupivacaine could decrease the need for additional&#xD;
           medications for pain control in addition to decreased mental stress for patients in this&#xD;
           unfamiliar situation, thus resulting in decreased episodes of delirium. The&#xD;
           investigators will assess delirium utilizing Confusion Assessment Method (CAM) scores in&#xD;
           the post-operative period at regularly scheduled intervals and compare average scores&#xD;
           between the treatment / standard of care group. Hypothesis: The investigators&#xD;
           hypothesize that total episodes of delirium will be decreased in the liposomal&#xD;
           bupivacaine group.&#xD;
&#xD;
        3. Determine if Exparel is cost-effective in hip fracture patients. The costs associated&#xD;
           with increased narcotic usage, prolonged stay, resources, and complications can be&#xD;
           significant. The use of liposomal bupivacaine may lead to decreased resource utilization&#xD;
           to care for hip fractures. The investigators will conduct an economic analysis&#xD;
           evaluating total inpatient hospitalization costs including costs associated with length&#xD;
           of stay, medication requirements, and resources associated with consultations and&#xD;
           diagnostic evaluations. These costs will be compared against the cost of Exparel&#xD;
           administration to evaluate the net cost effect of the intervention. Hypothesis: The&#xD;
           investigators hypothesize that the net cost of inpatient care will be decreased when&#xD;
           compared to standard of care.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">January 22, 2019</completion_date>
  <primary_completion_date type="Actual">January 1, 2019</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Opiate Requirements</measure>
    <time_frame>72 hours</time_frame>
    <description>Morphine meq given</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Hip Fractures</condition>
  <arm_group>
    <arm_group_label>Exparel (Liposomal Bupivacaine)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Exparel (liposomal bupivacaine) is FDA approved, with a labeled indication of &quot;single-dose infiltration into the surgical site to produce postsurgical analgesia.&quot;</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Saline Control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Saline Solution (Sodium Chloride)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Exparel</intervention_name>
    <description>Subcutaneous injection at conclusion of surgical fixation of hip fracture</description>
    <arm_group_label>Exparel (Liposomal Bupivacaine)</arm_group_label>
    <other_name>Liposomal Bupivacaine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sodium Chloride</intervention_name>
    <description>Saline Injection</description>
    <arm_group_label>Saline Control</arm_group_label>
    <other_name>Saline</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 55 or older&#xD;
&#xD;
          -  Sustaining either an OTA/AO type 31A or 31B fracture undergoing ORIF or&#xD;
             hemiarthroplasty&#xD;
&#xD;
          -  Able to consent&#xD;
&#xD;
          -  Isolated injury&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  OTA/AO 31B1 (Impacted/slightly displaced)&#xD;
&#xD;
          -  Baseline dementia or cognitive deficit&#xD;
&#xD;
          -  Inability to consent&#xD;
&#xD;
          -  Chronic Opioid use&#xD;
&#xD;
          -  End stage liver disease with Model for End-Stage Liver Disease (MELD) greater than 20.&#xD;
&#xD;
          -  End stage renal disease as defined by patients requiring hemodialysis at least twice&#xD;
             weekly&#xD;
&#xD;
          -  Polytrauma, defined as: concurrent upper or lower extremity fracture, pelvis fracture,&#xD;
             spine fracture, rib fractures, or facial fractures, Blunt chest or abdominal trauma&#xD;
             resulting in diagnosed organ injury, Head trauma resulting in intracranial bleed or&#xD;
             diagnosed concussion&#xD;
&#xD;
          -  Allergy to amide-type local anesthetics&#xD;
&#xD;
          -  Prisoners (unlikely to be accessible for follow-up)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>55 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric Swart, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UMASS Memorial Medical Center</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Paul Matuszewski, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Kentucky</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Kentucky</name>
      <address>
        <city>Lexington</city>
        <state>Kentucky</state>
        <zip>40536</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UMass Memorial Medical Center</name>
      <address>
        <city>Worcester</city>
        <state>Massachusetts</state>
        <zip>01655</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Brauer CA, Coca-Perraillon M, Cutler DM, Rosen AB. Incidence and mortality of hip fractures in the United States. JAMA. 2009 Oct 14;302(14):1573-9. doi: 10.1001/jama.2009.1462.</citation>
    <PMID>19826027</PMID>
  </reference>
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  <verification_date>March 2021</verification_date>
  <study_first_submitted>September 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <results_first_submitted>January 14, 2020</results_first_submitted>
  <results_first_submitted_qc>February 11, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">February 25, 2020</results_first_posted>
  <last_update_submitted>March 16, 2021</last_update_submitted>
  <last_update_submitted_qc>March 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Massachusetts, Worcester</investigator_affiliation>
    <investigator_full_name>Eric Swart</investigator_full_name>
    <investigator_title>Eric F. Swart, MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
    <mesh_term>Hip Fractures</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 15, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/58/NCT03289858/Prot_003.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 27, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/58/NCT03289858/SAP_004.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Exparel (Liposomal Bupivacaine)</title>
          <description>Exparel (liposomal bupivacaine) is FDA approved, with a labeled indication of &quot;single-dose infiltration into the surgical site to produce postsurgical analgesia.&quot;&#xD;
Exparel: Subcutaneous injection at conclusion of surgical fixation of hip fracture</description>
        </group>
        <group group_id="P2">
          <title>Saline Control</title>
          <description>Saline Solution (Sodium Chloride)&#xD;
Sodium Chloride: Saline Injection</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="25"/>
                <participants group_id="P2" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Exparel (Liposomal Bupivacaine)</title>
          <description>Exparel (liposomal bupivacaine) is FDA approved, with a labeled indication of &quot;single-dose infiltration into the surgical site to produce postsurgical analgesia.&quot;&#xD;
Exparel: Subcutaneous injection at conclusion of surgical fixation of hip fracture</description>
        </group>
        <group group_id="B2">
          <title>Saline Control</title>
          <description>Saline Solution (Sodium Chloride)&#xD;
Sodium Chloride: Saline Injection</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="27"/>
            <count group_id="B2" value="28"/>
            <count group_id="B3" value="55"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="27"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="76" spread="8.6"/>
                    <measurement group_id="B2" value="77" spread="9.2"/>
                    <measurement group_id="B3" value="76" spread="8.8"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="27"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="27"/>
                    <count group_id="B2" value="28"/>
                    <count group_id="B3" value="55"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="28"/>
                    <measurement group_id="B3" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Opiate Requirements</title>
        <description>Morphine meq given</description>
        <time_frame>72 hours</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Exparel (Liposomal Bupivacaine)</title>
            <description>Exparel (liposomal bupivacaine) is FDA approved, with a labeled indication of &quot;single-dose infiltration into the surgical site to produce postsurgical analgesia.&quot;&#xD;
Exparel: Subcutaneous injection at conclusion of surgical fixation of hip fracture</description>
          </group>
          <group group_id="O2">
            <title>Saline Control</title>
            <description>Saline Solution (Sodium Chloride)&#xD;
Sodium Chloride: Saline Injection</description>
          </group>
        </group_list>
        <measure>
          <title>Opiate Requirements</title>
          <description>Morphine meq given</description>
          <units>Morphine mEq</units>
          <param>Mean</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="25"/>
                <count group_id="O2" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52.5" lower_limit="30.21" upper_limit="74.75"/>
                    <measurement group_id="O2" value="65.39" lower_limit="45.68" upper_limit="85.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 months</time_frame>
      <desc>Patients were actively screened for a list of complications daily during their admission and at their 2 and 6 week follow up appointments.</desc>
      <group_list>
        <group group_id="E1">
          <title>Exparel (Liposomal Bupivacaine)</title>
          <description>Exparel (liposomal bupivacaine) is FDA approved, with a labeled indication of &quot;single-dose infiltration into the surgical site to produce postsurgical analgesia.&quot;&#xD;
Exparel: Subcutaneous injection at conclusion of surgical fixation of hip fracture</description>
        </group>
        <group group_id="E2">
          <title>Saline Control</title>
          <description>Saline Solution (Sodium Chloride)&#xD;
Sodium Chloride: Saline Injection</description>
        </group>
      </group_list>
      <serious_events>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="27"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="28"/>
              </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="27"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="28"/>
              </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>
    <point_of_contact>
      <name_or_title>Eric Swart</name_or_title>
      <organization>University of Massachusetts, Worcester</organization>
      <phone>503-880-7125</phone>
      <email>eric.swart@umassmemorial.org</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/NCT03289858
org study id: H00013594
nct id: NCT03289858
lead sponsor: 
collaborator: 
collaborator: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
This is a prospective, randomized study looking at the effect that a long-acting local
      anesthetic has on pain control in patients having surgery for hip fractures. The
      investigators are conducting the study to see if that reduces the amount of pain medicine
      needed after surgery, and if it reduces other medical complications after surgery.
Osteoporotic fragility fractures of the hip are common in the geriatric population, are
      increasing in frequency, and represent a growing social and economic burden. Pain control
      after surgical treatment is an area of growing interest, as improvement in post-injury pain
      is often an important indication for surgical treatment of hip fractures.

      Typically a mainstay of post-operative pain control, the use of opiates has come under
      increasing scrutiny, as it has been shown to be associated with delirium, respiratory
      depression, and even may even lead to addiction or abuse in the medically frail geriatric
      population. These concerns have led to efforts to minimize the use of post-operative opiates
      in hip fracture patients. In that context, a treatment that could reduce the necessity of
      post-op narcotics while still improving pain control would be potentially valuable.

      There has been growing interest in the use of long-acting local anesthetics for improving
      pain control in orthopaedics, particularly in the elective total joint arthroplasty
      population. Studies have shown that arthroplasty patients receiving long-acting local
      anesthetics have decreased opiate requirements, reduced length of stay, and lower costs.
      Although well-demonstrated in the elective arthroplasty population, the effects of
      long-acting local anesthetics have yet to be demonstrated in the hip fracture population.
      Given that these fractures frequently occur in medically frail patients with multiple
      comorbidities, in whom post-operative confusion and delirium are relatively common, there is
      the potential for treatments that decrease opiate requirements to demonstrate substantial
      medical and economic benefits.

      Exparel (liposomal bupivacaine) and long-acting local anesthetics have been used extensively
      in hip replacement surgery and have not been shown to be associated with any increased risks.
      In the case of patients with displaced femoral neck fractures treated with arthroplasty, the
      surgical techniques are identical to those being used in this study. Exparel has also been
      used in trauma surgery as well as foot and ankle surgery without any increased described
      risks, although its use explicitly in hip fractures has not been published. However, the PI
      has trained in other medical centers where Exparel is routinely used in hip fracture patients
      without any identified increased risks or complications, but there is a paucity of data on
      this subject, which is the rationale for this study.

      The investigators hypothesize that in patients with osteoporotic fragility fractures of the
      hip, patients receiving intraoperative long-acting local anesthetics will have decreased pain
      and decreased post-operative opiate requirements, leading to less delirium and decreased
      hospital resource utilization during their index hospitalization.

      The goal is to conduct a multi-center prospective randomized control trial to determine if
      liposomal bupivacaine is superior to standard of care by addressing the below separate but
      related aims:

        1. Determine the effectiveness of Exparel to reduce narcotic requirements and pain post
           operatively after hip fracture treatment. Excess narcotic use in the elderly population
           is associated with a host of complications often magnified by polypharmacy, including in
           hospital delirium, increased length of stay, nausea, constipation, urinary retention,
           respiratory depression and others. Decreasing narcotic usage in this group of patients
           following hip fracture can possibly reduce such complications. Patients will receive
           standard of care medical treatment and be randomized to intra-operative Exparel vs.
           placebo injections. Opioid requirements, complications, pain score, and length of stay
           will be assessed in the post-operative period. Hypothesis: The investigators hypothesize
           that total morphine requirements and pain scores will be decreased in this group
           following the administration of exparel in the geriatric hip fracture fracture
           population.

        2. Determine the effectiveness of Exparel to reduce delirium in post-operative hip fracture
           patients. In hospital delirium in elderly patients is associated with poor outcomes,
           including prolonged length of stay, poor participation in rehabilitation, and falls. Use
           of a locally administered liposomal bupivacaine could decrease the need for additional
           medications for pain control in addition to decreased mental stress for patients in this
           unfamiliar situation, thus resulting in decreased episodes of delirium. The
           investigators will assess delirium utilizing Confusion Assessment Method (CAM) scores in
           the post-operative period at regularly scheduled intervals and compare average scores
           between the treatment / standard of care group. Hypothesis: The investigators
           hypothesize that total episodes of delirium will be decreased in the liposomal
           bupivacaine group.

        3. Determine if Exparel is cost-effective in hip fracture patients. The costs associated
           with increased narcotic usage, prolonged stay, resources, and complications can be
           significant. The use of liposomal bupivacaine may lead to decreased resource utilization
           to care for hip fractures. The investigators will conduct an economic analysis
           evaluating total inpatient hospitalization costs including costs associated with length
           of stay, medication requirements, and resources associated with consultations and
           diagnostic evaluations. These costs will be compared against the cost of Exparel
           administration to evaluate the net cost effect of the intervention. Hypothesis: The
           investigators hypothesize that the net cost of inpatient care will be decreased when
           compared to standard of care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Opiate Requirements
time frame: 72 hours
description: Morphine meq given
arm group label: Exparel (Liposomal Bupivacaine)
arm group type: Experimental
description: Exparel (liposomal bupivacaine) is FDA approved, with a labeled indication of "single-dose infiltration into the surgical site to produce postsurgical analgesia."
arm group label: Saline Control
arm group type: Placebo Comparator
description: Saline Solution (Sodium Chloride)
intervention type: Drug
intervention name: Exparel
description: Subcutaneous injection at conclusion of surgical fixation of hip fracture
arm group label: Exparel (Liposomal Bupivacaine)
other name: Liposomal Bupivacaine
intervention type: Drug
intervention name: Sodium Chloride
description: Saline Injection
arm group label: Saline Control
other name: Saline
criteria: 
gender: All
minimum age: 55 Years
maximum age: N/A
healthy volunteers: No
last name: Eric Swart, MD
role: Principal Investigator
affiliation: UMASS Memorial Medical Center
last name: Paul Matuszewski, MD
role: Principal Investigator
affiliation: University of Kentucky
facility: 
facility: 
country: United States
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responsible party type: Principal Investigator
investigator affiliation: University of Massachusetts, Worcester
investigator full name: Eric Swart
investigator title: Eric F. Swart, MD
mesh term: Fractures, Bone
mesh term: Hip Fractures
mesh term: Bupivacaine
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 