<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/NCT02242201</url>
  </required_header>
  <id_info>
    <org_study_id>14-004183</org_study_id>
    <secondary_id>UL1TR000135</secondary_id>
    <nct_id>NCT02242201</nct_id>
  </id_info>
  <brief_title>Total Hip Arthroplasty (THA) Lumbar Plexus Verses Periarticular</brief_title>
  <official_title>Prospective, Randomized Controlled Trial Comparing Continuous Posterior Lumbar Plexus Nerve Block vs Periarticular Injection With Ropivacaine or Liposomal Bupivacaine (Exparel&amp;#174;) on Patients Undergoing Total Hip Arthroplasty</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <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>
      Total hip arthroplasty is a one of the most commonly performed surgical procedures with&#xD;
      increasing numbers anticipated over the next several decades. The purpose of this study was&#xD;
      to find a better way to make patients comfortable after their hip surgery. Three different&#xD;
      ways of providing pain relief were compared, a peripheral nerve block in the lower back&#xD;
      outside of the spinal space (using bupivacaine, a numbing medicine), or injections around the&#xD;
      hip joint with one of two different medicines, either Ropivacaine or Liposomal Bupivacaine&#xD;
      (Exparel®).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Total hip arthroplasty is associated with moderate to severe postoperative pain and an ideal&#xD;
      clinical pathway for pain management has yet to be established. Multimodal pain management&#xD;
      incorporating the use of regional anesthesia for THA has led to decreased hospital length of&#xD;
      stay, improved patient comfort, and enhanced patient satisfaction that is efficacious and&#xD;
      cost-effective. This investigation compared multimodal total joint arthroplasty pathways with&#xD;
      continuous lumbar plexus blockade versus two different periarticular injection mixtures to&#xD;
      potentially determine an ideal perioperative analgesia pathway for THA.&#xD;
&#xD;
      Patients undergoing elective, unilateral primary total hip arthroplasty within a clinical&#xD;
      pathway utilizing preemptive low-dose opioid and non-opioid medications for multimodal&#xD;
      analgesia were randomized to one of three different intervention groups after informed&#xD;
      consent was obtained: posterior lumbar plexus block (PNB), periarticular infiltration (PAI)&#xD;
      with ropivacaine, ketorolac, and epinephrine, and PAI with liposomal bupivacaine, ketorolac,&#xD;
      and epinephrine. The investigators hypothesized differences in the analgesia outcomes between&#xD;
      the three intervention groups would provide for an evidenced-based clinical pathway to emerge&#xD;
      as a result of this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">September 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum Postoperative Pain Score</measure>
    <time_frame>Post-Operative Day 1 (0600-1200)</time_frame>
    <description>Pain was measured on an ascending numeric rating scale (NRS) from 0-10 where 1-3 equaled mild pain, 4-6 equaled moderate pain, 7-9 equaled severe pain, and 10 equaled worst possible pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Total Opioid Consumption During Hospitalization</measure>
    <time_frame>Preoperative, Intraoperative, Postanesthesia Care Unit (PACU), Post Operative Day (POD) 0, day 1, and day 2</time_frame>
    <description>Measured in daily oral morphine equivalents (OME)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Hospital Length of Stay</measure>
    <time_frame>Post-operative Day 1 through discharge (approximately 3 days)</time_frame>
    <description>Discharge readiness was evaluated by the surgical team during morning and afternoon physical therapy sessions.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Unipedal Stance Time</measure>
    <time_frame>Baseline, 3 months</time_frame>
    <description>Length of time in seconds a patient could stand on involved leg</description>
  </other_outcome>
  <other_outcome>
    <measure>Post-Operative Pain Score</measure>
    <time_frame>3 month follow-up</time_frame>
    <description>Pain intensity (NRS) assessment at 3 month follow-up. Pain was measured on an ascending numeric rating scale (NRS) from 0-10 where 1-3 equaled mild pain, 4-6 equaled moderate pain, 7-9 equaled severe pain, and 10 equaled worst possible pain.</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Short Form-36 (SF-36) Quality of Life Physical Component</measure>
    <time_frame>Baseline, 3 months</time_frame>
    <description>Scores on the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36). Subjects completed the SF-36 which consists of 8 sub-scales ranging from 0 to 100, with (0 = worst imaginable, 100 = best imaginable).</description>
  </other_outcome>
  <other_outcome>
    <measure>Change in Short Form-36 (SF-36) Quality of Life Mental Component</measure>
    <time_frame>Baseline, 3 months</time_frame>
    <description>Scores on the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36). Subjects completed the SF-36 which consists of 8 sub-scales ranging from 0 to 100, with (0 = worst imaginable, 100 = best imaginable).</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants Reporting Complications Since Surgery</measure>
    <time_frame>Post-operative Day 1 Through 3 - Month Follow-up</time_frame>
    <description>Complications were collected by telephone interview after surgery.</description>
  </other_outcome>
  <other_outcome>
    <measure>Number of Participants Reporting a NRS Pain Score Greater Than 3</measure>
    <time_frame>3 month follow up</time_frame>
    <description>Pain was measured on an ascending numeric rating scale (NRS) from 0-10 where 1-3 equaled mild pain, 4-6 equaled moderate pain, 7-9 equaled severe pain, and 10 equaled worst possible pain.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">165</enrollment>
  <condition>Total Hip Arthroplasty</condition>
  <arm_group>
    <arm_group_label>PNB Bupivacaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bupivacaine 0.5% with 1:200,000 epinephrine 30 ml bolus preoperatively followed by an infusion of bupivacaine 0.2% on post anesthesia care unit (PACU) arrival.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PAI Ropivacaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients 50 to 74.9 kg: ropivacaine 200 mg, epinephrine 100 ug, ketorolac 30 mg. Patients 75 to 99.9 kg: ropivacaine 300 mg, epinephrine 200 ug, ketorolac 30 mg. Patients 100 to 125 kg: ropivacaine 400 mg, epinephrine 300 ug, ketorolac 30mg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PAI liposomal bupivacaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PNB Bupivacaine</intervention_name>
    <description>Infusion</description>
    <arm_group_label>PNB Bupivacaine</arm_group_label>
    <other_name>Marcaine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PAI Ropivacaine</intervention_name>
    <description>Injection</description>
    <arm_group_label>PAI Ropivacaine</arm_group_label>
    <other_name>Naropin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>PAI liposomal bupivacaine</intervention_name>
    <description>Injection</description>
    <arm_group_label>PAI liposomal bupivacaine</arm_group_label>
    <other_name>Exparel</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Epinephrine</intervention_name>
    <description>Injection, weight-based dosage of 100 mcg - 300 mcg</description>
    <arm_group_label>PAI Ropivacaine</arm_group_label>
    <arm_group_label>PAI liposomal bupivacaine</arm_group_label>
    <arm_group_label>PNB Bupivacaine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ketorolac</intervention_name>
    <description>Injection, 30 mg</description>
    <arm_group_label>PAI Ropivacaine</arm_group_label>
    <arm_group_label>PAI liposomal bupivacaine</arm_group_label>
    <other_name>Acuvail</other_name>
    <other_name>Acular</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adult patients with an American Society of Anesthesiologists (ASA) physiological&#xD;
             status I-III&#xD;
&#xD;
          2. Patients presenting for unilateral primary total hip arthroplasty&#xD;
&#xD;
          3. Patients 18 years of age and older&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Chronic pain syndromes such as fibromyalgia or complex regional pain syndrome&#xD;
&#xD;
          2. History of long term use of daily opioids (&gt;1 months) with Oral Morphine Equivalent&#xD;
             (OME) &gt;5mg/day&#xD;
&#xD;
          3. Body mass index (BMI) &gt; 40 kg/m2&#xD;
&#xD;
          4. Allergies to medications used in this study such as: fentanyl,hydromorphone,&#xD;
             ketorolac, ibuprofen, acetaminophen, local anesthetics, oxycodone, tramadol,&#xD;
             ondansetron, droperidol, dexamethasone, celecoxib and OxyContin&#xD;
&#xD;
          5. Major systemic medical problems such as:&#xD;
&#xD;
               1. severe renal disorder defined as glomerular filtration rate (GFR) &lt;50 units/m2&#xD;
&#xD;
               2. cardiovascular disorders defined as Congestive Heart Failure (CHF) New York Heart&#xD;
                  Association (NYHA) class III-IV&#xD;
&#xD;
               3. severe hepatic disorder defined as current or past diagnosis of acute/subacute&#xD;
                  necrosis of liver, acute hepatic failure, chronic liver disease, cirrhosis&#xD;
                  (primary biliary cirrhosis), fatty liver, chronic hepatitis/toxic hepatitis,&#xD;
                  liver abscess, hepatic coma, hepatorenal syndrome, other disorders of liver&#xD;
&#xD;
          6. Impaired cognitive function or inability to understand the study protocol&#xD;
&#xD;
          7. Contraindication to a regional anesthesia technique (e.g., preexisting neuropathy in&#xD;
             the operative extremity, coagulopathy [platelets &lt; 100,000, International Normalized&#xD;
             Ratio (INR) &gt;1.5], refusal, etc.).&#xD;
&#xD;
          8. Previous contralateral hip replacement managed with regional or periarticular&#xD;
             injection&#xD;
&#xD;
          9. Unable to follow-up at the 3 month interval at Mayo Clinic in Rochester, Minnesota&#xD;
&#xD;
         10. Pregnancy or breastfeeding (women of child-bearing potential will require a negative&#xD;
             pregnancy test)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rebecca Johnson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>Johnson RL, Amundson AW, Abdel MP, Sviggum HP, Mabry TM, Mantilla CB, Schroeder DR, Pagnano MW, Kopp SL. Continuous Posterior Lumbar Plexus Nerve Block Versus Periarticular Injection with Ropivacaine or Liposomal Bupivacaine for Total Hip Arthroplasty: A Three-Arm Randomized Clinical Trial. J Bone Joint Surg Am. 2017 Nov 1;99(21):1836-1845. doi: 10.2106/JBJS.16.01305.</citation>
    <PMID>29088038</PMID>
  </results_reference>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>September 13, 2014</study_first_submitted>
  <study_first_submitted_qc>September 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <results_first_submitted>December 13, 2017</results_first_submitted>
  <results_first_submitted_qc>January 13, 2018</results_first_submitted_qc>
  <results_first_posted type="Actual">January 17, 2018</results_first_posted>
  <last_update_submitted>March 21, 2018</last_update_submitted>
  <last_update_submitted_qc>March 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">April 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Rebecca L Johnson, MD</investigator_full_name>
    <investigator_title>PI</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ketorolac</mesh_term>
    <mesh_term>Epinephrine</mesh_term>
    <mesh_term>Bupivacaine</mesh_term>
    <mesh_term>Ropivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>PNB Bupivacaine</title>
          <description>Bupivacaine 0.5% with 1:200,000 epinephrine 30 ml bolus preoperatively followed by an infusion of bupivacaine 0.2% on post anesthesia care unit (PACU) arrival.&#xD;
Posterior lumbar plexus block (PNB) Bupivacaine: Infusion&#xD;
Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg</description>
        </group>
        <group group_id="P2">
          <title>PAI Ropivacaine</title>
          <description>Patients 50 to 74.9 kg: ropivacaine 200 mg, epinephrine 100 ug, ketorolac 30 mg. Patients 75 to 99.9 kg: ropivacaine 300 mg, epinephrine 200 ug, ketorolac 30 mg. Patients 100 to 125 kg: ropivacaine 400 mg, epinephrine 300 ug, ketorolac 30mg.&#xD;
Periarticular infiltration (PAI) Ropivacaine: Injection&#xD;
Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg&#xD;
Ketorolac: Injection, 30 mg</description>
        </group>
        <group group_id="P3">
          <title>PAI Liposomal Bupivacaine</title>
          <description>Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug.&#xD;
PAI liposomal bupivacaine: Injection&#xD;
Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg&#xD;
Ketorolac: Injection, 30 mg</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="55"/>
                <participants group_id="P2" count="55"/>
                <participants group_id="P3" count="55"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="51"/>
                <participants group_id="P2" count="54"/>
                <participants group_id="P3" count="54"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>preoperative identified neuropathy</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>planned post-op anticoagulation</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>changed surgical procedure</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>postponed surgery</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>preoperative opioid consumption</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>PNB Bupivacaine</title>
          <description>Bupivacaine 0.5% with 1:200,000 epinephrine 30 ml bolus preoperatively followed by an infusion of bupivacaine 0.2% on post anesthesia care unit (PACU) arrival.&#xD;
PNB Bupivacaine: Infusion&#xD;
Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg</description>
        </group>
        <group group_id="B2">
          <title>PAI Ropivacaine</title>
          <description>Patients 50 to 74.9 kg: ropivacaine 200 mg, epinephrine 100 ug, ketorolac 30 mg. Patients 75 to 99.9 kg: ropivacaine 300 mg, epinephrine 200 ug, ketorolac 30 mg. Patients 100 to 125 kg: ropivacaine 400 mg, epinephrine 300 ug, ketorolac 30mg.&#xD;
PAI Ropivacaine: Injection&#xD;
Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg&#xD;
Ketorolac: Injection, 30 mg</description>
        </group>
        <group group_id="B3">
          <title>PAI Liposomal Bupivacaine</title>
          <description>Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug.&#xD;
PAI liposomal bupivacaine: Injection&#xD;
Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg&#xD;
Ketorolac: Injection, 30 mg</description>
        </group>
        <group group_id="B4">
          <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="51"/>
            <count group_id="B2" value="54"/>
            <count group_id="B3" value="54"/>
            <count group_id="B4" value="159"/>
          </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="51"/>
                    <count group_id="B2" value="54"/>
                    <count group_id="B3" value="54"/>
                    <count group_id="B4" value="159"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="62.1" spread="11.5"/>
                    <measurement group_id="B2" value="59.4" spread="15.3"/>
                    <measurement group_id="B3" value="61.7" spread="11.7"/>
                    <measurement group_id="B4" value="61.0" spread="12.9"/>
                  </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="51"/>
                    <count group_id="B2" value="54"/>
                    <count group_id="B3" value="54"/>
                    <count group_id="B4" value="159"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="28"/>
                    <measurement group_id="B4" value="80"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="26"/>
                    <measurement group_id="B4" value="79"/>
                  </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 group_id="B4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B4" 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="51"/>
                    <count group_id="B2" value="54"/>
                    <count group_id="B3" value="54"/>
                    <count group_id="B4" value="159"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="54"/>
                    <measurement group_id="B4" value="159"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Duration of surgery</title>
          <units>minutes</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="51"/>
                    <count group_id="B2" value="54"/>
                    <count group_id="B3" value="54"/>
                    <count group_id="B4" value="159"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="91.4" spread="24.0"/>
                    <measurement group_id="B2" value="88.1" spread="23.2"/>
                    <measurement group_id="B3" value="88.4" spread="28.3"/>
                    <measurement group_id="B4" value="89.2" spread="25.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Type of anesthetic</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="51"/>
                    <count group_id="B2" value="54"/>
                    <count group_id="B3" value="54"/>
                    <count group_id="B4" value="159"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>General</title>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="36"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Spinal</title>
                  <measurement_list>
                    <measurement group_id="B1" value="38"/>
                    <measurement group_id="B2" value="44"/>
                    <measurement group_id="B3" value="41"/>
                    <measurement group_id="B4" value="123"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>American Society of Anesthesiologists (ASA) Status</title>
          <description>The ASA Physical Status Classification System assesses the fitness of patients prior to surgery. It defines an ASA I as a normal healthy patient, ASA II as a patient with mild systemic disease, and ASA III as a patient with severe systemic disease.</description>
          <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="51"/>
                    <count group_id="B2" value="54"/>
                    <count group_id="B3" value="54"/>
                    <count group_id="B4" value="159"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>I or II</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="45"/>
                    <measurement group_id="B4" value="130"/>
                  </measurement_list>
                </category>
                <category>
                  <title>III</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="9"/>
                    <measurement group_id="B4" value="29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m2</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="51"/>
                    <count group_id="B2" value="54"/>
                    <count group_id="B3" value="54"/>
                    <count group_id="B4" value="159"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30.0" spread="6.0"/>
                    <measurement group_id="B2" value="30.1" spread="6.0"/>
                    <measurement group_id="B3" value="30.2" spread="5.4"/>
                    <measurement group_id="B4" value="30.1" spread="5.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Maximum Postoperative Pain Score</title>
        <description>Pain was measured on an ascending numeric rating scale (NRS) from 0-10 where 1-3 equaled mild pain, 4-6 equaled moderate pain, 7-9 equaled severe pain, and 10 equaled worst possible pain.</description>
        <time_frame>Post-Operative Day 1 (0600-1200)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>PNB Bupivacaine</title>
            <description>Bupivacaine 0.5% with 1:200,000 epinephrine 30 ml bolus preoperatively followed by an infusion of bupivacaine 0.2% on post anesthesia care unit (PACU) arrival.&#xD;
PNB Bupivacaine: Infusion&#xD;
Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg</description>
          </group>
          <group group_id="O2">
            <title>PAI Ropivacaine</title>
            <description>Patients 50 to 74.9 kg: ropivacaine 200 mg, epinephrine 100 ug, ketorolac 30 mg. Patients 75 to 99.9 kg: ropivacaine 300 mg, epinephrine 200 ug, ketorolac 30 mg. Patients 100 to 125 kg: ropivacaine 400 mg, epinephrine 300 ug, ketorolac 30mg.&#xD;
PAI Ropivacaine: Injection&#xD;
Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg&#xD;
Ketorolac: Injection, 30 mg</description>
          </group>
          <group group_id="O3">
            <title>PAI Liposomal Bupivacaine</title>
            <description>Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug.&#xD;
PAI liposomal bupivacaine: Injection&#xD;
Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg&#xD;
Ketorolac: Injection, 30 mg</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Postoperative Pain Score</title>
          <description>Pain was measured on an ascending numeric rating scale (NRS) from 0-10 where 1-3 equaled mild pain, 4-6 equaled moderate pain, 7-9 equaled severe pain, and 10 equaled worst possible pain.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="54"/>
                <count group_id="O3" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.0" lower_limit="1" upper_limit="4"/>
                    <measurement group_id="O2" value="4.0" lower_limit="2" upper_limit="5"/>
                    <measurement group_id="O3" value="3.0" lower_limit="2" upper_limit="5"/>
                  </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</non_inferiority_type>
            <p_value>0.033</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.662</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.103</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Total Opioid Consumption During Hospitalization</title>
        <description>Measured in daily oral morphine equivalents (OME)</description>
        <time_frame>Preoperative, Intraoperative, Postanesthesia Care Unit (PACU), Post Operative Day (POD) 0, day 1, and day 2</time_frame>
        <population>For Post Operative Day (POD) 2, data were missing for 26 subjects (7 in the PNB group, 9 in the PAI-R group, and 10 in the PAI-L group).</population>
        <group_list>
          <group group_id="O1">
            <title>PNB Bupivacaine</title>
            <description>Bupivacaine 0.5% with 1:200,000 epinephrine 30 ml bolus preoperatively followed by an infusion of bupivacaine 0.2% on post anesthesia care unit (PACU) arrival.&#xD;
PNB Bupivacaine: Infusion&#xD;
Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg</description>
          </group>
          <group group_id="O2">
            <title>PAI Ropivacaine</title>
            <description>Patients 50 to 74.9 kg: ropivacaine 200 mg, epinephrine 100 ug, ketorolac 30 mg. Patients 75 to 99.9 kg: ropivacaine 300 mg, epinephrine 200 ug, ketorolac 30 mg. Patients 100 to 125 kg: ropivacaine 400 mg, epinephrine 300 ug, ketorolac 30mg.&#xD;
PAI Ropivacaine: Injection&#xD;
Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg&#xD;
Ketorolac: Injection, 30 mg</description>
          </group>
          <group group_id="O3">
            <title>PAI Liposomal Bupivacaine</title>
            <description>Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug.&#xD;
PAI liposomal bupivacaine: Injection&#xD;
Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg&#xD;
Ketorolac: Injection, 30 mg</description>
          </group>
        </group_list>
        <measure>
          <title>Total Opioid Consumption During Hospitalization</title>
          <description>Measured in daily oral morphine equivalents (OME)</description>
          <population>For Post Operative Day (POD) 2, data were missing for 26 subjects (7 in the PNB group, 9 in the PAI-R group, and 10 in the PAI-L group).</population>
          <units>Oral morphine equivalent in milligrams</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="54"/>
                <count group_id="O3" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Preoperative</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="54"/>
                    <count group_id="O3" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15" lower_limit="0" upper_limit="30"/>
                    <measurement group_id="O2" value="15" lower_limit="0" upper_limit="30"/>
                    <measurement group_id="O3" value="15" lower_limit="15" upper_limit="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Intraoperative</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="54"/>
                    <count group_id="O3" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10" lower_limit="5" upper_limit="20"/>
                    <measurement group_id="O2" value="10" lower_limit="5" upper_limit="15"/>
                    <measurement group_id="O3" value="10" lower_limit="5" upper_limit="20"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Postanesthesia Care Unit (PACU)</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="54"/>
                    <count group_id="O3" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="10"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="0" lower_limit="0" upper_limit="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post Operative Day (POD) 0 post PACU</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="54"/>
                    <count group_id="O3" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.5" lower_limit="0" upper_limit="30"/>
                    <measurement group_id="O2" value="15" lower_limit="0" upper_limit="30"/>
                    <measurement group_id="O3" value="11.3" lower_limit="0" upper_limit="22.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>POD 1</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="51"/>
                    <count group_id="O2" value="54"/>
                    <count group_id="O3" value="54"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.5" lower_limit="7.5" upper_limit="60"/>
                    <measurement group_id="O2" value="33.8" lower_limit="7.5" upper_limit="60"/>
                    <measurement group_id="O3" value="15" lower_limit="7.5" upper_limit="45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>POD 2</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="O1" value="44"/>
                    <count group_id="O2" value="45"/>
                    <count group_id="O3" value="44"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15" lower_limit="0" upper_limit="30"/>
                    <measurement group_id="O2" value="15" lower_limit="0" upper_limit="45"/>
                    <measurement group_id="O3" value="11.3" lower_limit="0" upper_limit="18.8"/>
                  </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>
            <groups_desc>Preoperative</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.948</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Preoperative</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.880</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Preoperative</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.802</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Intraoperative</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.179</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Intraoperative</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.837</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Intraoperative</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.142</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>PACU</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.010</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>PACU</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.516</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>PACU</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.052</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>POD 0 post PACU</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.840</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>POD 0 post PACU</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.744</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>POD 0 post PACU</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.501</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>POD 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.358</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>POD 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.536</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>POD 1</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.110</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>POD 2</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.313</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>POD 2</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.893</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>POD 2</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.232</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Hospital Length of Stay</title>
        <description>Discharge readiness was evaluated by the surgical team during morning and afternoon physical therapy sessions.</description>
        <time_frame>Post-operative Day 1 through discharge (approximately 3 days)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>PNB Bupivacaine</title>
            <description>Bupivacaine 0.5% with 1:200,000 epinephrine 30 ml bolus preoperatively followed by an infusion of bupivacaine 0.2% on post anesthesia care unit (PACU) arrival.&#xD;
PNB Bupivacaine: Infusion&#xD;
Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg</description>
          </group>
          <group group_id="O2">
            <title>PAI Ropivacaine</title>
            <description>Patients 50 to 74.9 kg: ropivacaine 200 mg, epinephrine 100 ug, ketorolac 30 mg. Patients 75 to 99.9 kg: ropivacaine 300 mg, epinephrine 200 ug, ketorolac 30 mg. Patients 100 to 125 kg: ropivacaine 400 mg, epinephrine 300 ug, ketorolac 30mg.&#xD;
PAI Ropivacaine: Injection&#xD;
Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg&#xD;
Ketorolac: Injection, 30 mg</description>
          </group>
          <group group_id="O3">
            <title>PAI Liposomal Bupivacaine</title>
            <description>Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug.&#xD;
PAI liposomal bupivacaine: Injection&#xD;
Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg&#xD;
Ketorolac: Injection, 30 mg</description>
          </group>
        </group_list>
        <measure>
          <title>Hospital Length of Stay</title>
          <description>Discharge readiness was evaluated by the surgical team during morning and afternoon physical therapy sessions.</description>
          <units>days</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="51"/>
                <count group_id="O2" value="54"/>
                <count group_id="O3" value="54"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" lower_limit="2" upper_limit="2"/>
                    <measurement group_id="O2" value="2" lower_limit="2" upper_limit="3"/>
                    <measurement group_id="O3" value="2" lower_limit="2" upper_limit="2"/>
                  </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>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.772</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change in Unipedal Stance Time</title>
        <description>Length of time in seconds a patient could stand on involved leg</description>
        <time_frame>Baseline, 3 months</time_frame>
        <population>Data were available for 50, 54, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively.</population>
        <group_list>
          <group group_id="O1">
            <title>PNB Bupivacaine</title>
            <description>Bupivacaine 0.5% with 1:200,000 epinephrine 30 ml bolus preoperatively followed by an infusion of bupivacaine 0.2% on post anesthesia care unit (PACU) arrival.&#xD;
PNB Bupivacaine: Infusion&#xD;
Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg</description>
          </group>
          <group group_id="O2">
            <title>PAI Ropivacaine</title>
            <description>Patients 50 to 74.9 kg: ropivacaine 200 mg, epinephrine 100 ug, ketorolac 30 mg. Patients 75 to 99.9 kg: ropivacaine 300 mg, epinephrine 200 ug, ketorolac 30 mg. Patients 100 to 125 kg: ropivacaine 400 mg, epinephrine 300 ug, ketorolac 30mg.&#xD;
PAI Ropivacaine: Injection&#xD;
Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg&#xD;
Ketorolac: Injection, 30 mg</description>
          </group>
          <group group_id="O3">
            <title>PAI Liposomal Bupivacaine</title>
            <description>Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug.&#xD;
PAI liposomal bupivacaine: Injection&#xD;
Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg&#xD;
Ketorolac: Injection, 30 mg</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Unipedal Stance Time</title>
          <description>Length of time in seconds a patient could stand on involved leg</description>
          <population>Data were available for 50, 54, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively.</population>
          <units>seconds</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="54"/>
                <count group_id="O3" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.5" lower_limit="6" upper_limit="30"/>
                    <measurement group_id="O2" value="30" lower_limit="9" upper_limit="30"/>
                    <measurement group_id="O3" value="30" lower_limit="7" upper_limit="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 months</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30" lower_limit="12" upper_limit="30"/>
                    <measurement group_id="O2" value="30" lower_limit="18" upper_limit="30"/>
                    <measurement group_id="O3" value="30" lower_limit="15" upper_limit="30"/>
                  </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>O3</group_id>
            </group_id_list>
            <groups_desc>Baseline</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.251</p_value>
            <method>Regression, Cox</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>3 month follow-up</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.300</p_value>
            <method>Regression, Cox</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Baseline vs 3 months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.113</p_value>
            <method>Regression, Cox</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Baseline vs 3 months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.147</p_value>
            <method>Regression, Cox</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Baseline vs 3 months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.216</p_value>
            <method>Regression, Cox</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Baseline vs 3 months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.968</p_value>
            <method>Regression, Cox</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Post-Operative Pain Score</title>
        <description>Pain intensity (NRS) assessment at 3 month follow-up. Pain was measured on an ascending numeric rating scale (NRS) from 0-10 where 1-3 equaled mild pain, 4-6 equaled moderate pain, 7-9 equaled severe pain, and 10 equaled worst possible pain.</description>
        <time_frame>3 month follow-up</time_frame>
        <population>Data were available for 50, 54, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively.</population>
        <group_list>
          <group group_id="O1">
            <title>PNB Bupivacaine</title>
            <description>Bupivacaine 0.5% with 1:200,000 epinephrine 30 ml bolus preoperatively followed by an infusion of bupivacaine 0.2% on post anesthesia care unit (PACU) arrival.&#xD;
PNB Bupivacaine: Infusion&#xD;
Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg</description>
          </group>
          <group group_id="O2">
            <title>PAI Ropivacaine</title>
            <description>Patients 50 to 74.9 kg: ropivacaine 200 mg, epinephrine 100 ug, ketorolac 30 mg. Patients 75 to 99.9 kg: ropivacaine 300 mg, epinephrine 200 ug, ketorolac 30 mg. Patients 100 to 125 kg: ropivacaine 400 mg, epinephrine 300 ug, ketorolac 30mg.&#xD;
PAI Ropivacaine: Injection&#xD;
Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg&#xD;
Ketorolac: Injection, 30 mg</description>
          </group>
          <group group_id="O3">
            <title>PAI Liposomal Bupivacaine</title>
            <description>Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug.&#xD;
PAI liposomal bupivacaine: Injection&#xD;
Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg&#xD;
Ketorolac: Injection, 30 mg</description>
          </group>
        </group_list>
        <measure>
          <title>Post-Operative Pain Score</title>
          <description>Pain intensity (NRS) assessment at 3 month follow-up. Pain was measured on an ascending numeric rating scale (NRS) from 0-10 where 1-3 equaled mild pain, 4-6 equaled moderate pain, 7-9 equaled severe pain, and 10 equaled worst possible pain.</description>
          <population>Data were available for 50, 54, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively.</population>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="54"/>
                <count group_id="O3" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pain at rest</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="0"/>
                    <measurement group_id="O3" value="0" lower_limit="0" upper_limit="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain with movement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="1"/>
                    <measurement group_id="O2" value="1" lower_limit="0" upper_limit="2"/>
                    <measurement group_id="O3" value="1" lower_limit="0" upper_limit="2"/>
                  </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>O3</group_id>
            </group_id_list>
            <groups_desc>Pain at rest</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.776</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Pain with movement</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.447</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change in Short Form-36 (SF-36) Quality of Life Physical Component</title>
        <description>Scores on the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36). Subjects completed the SF-36 which consists of 8 sub-scales ranging from 0 to 100, with (0 = worst imaginable, 100 = best imaginable).</description>
        <time_frame>Baseline, 3 months</time_frame>
        <population>Data were available for 50, 52, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively.</population>
        <group_list>
          <group group_id="O1">
            <title>PNB Bupivacaine</title>
            <description>Bupivacaine 0.5% with 1:200,000 epinephrine 30 ml bolus preoperatively followed by an infusion of bupivacaine 0.2% on post anesthesia care unit (PACU) arrival.&#xD;
PNB Bupivacaine: Infusion&#xD;
Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg</description>
          </group>
          <group group_id="O2">
            <title>PAI Ropivacaine</title>
            <description>Patients 50 to 74.9 kg: ropivacaine 200 mg, epinephrine 100 ug, ketorolac 30 mg. Patients 75 to 99.9 kg: ropivacaine 300 mg, epinephrine 200 ug, ketorolac 30 mg. Patients 100 to 125 kg: ropivacaine 400 mg, epinephrine 300 ug, ketorolac 30mg.&#xD;
PAI Ropivacaine: Injection&#xD;
Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg&#xD;
Ketorolac: Injection, 30 mg</description>
          </group>
          <group group_id="O3">
            <title>PAI Liposomal Bupivacaine</title>
            <description>Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug.&#xD;
PAI liposomal bupivacaine: Injection&#xD;
Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg&#xD;
Ketorolac: Injection, 30 mg</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Short Form-36 (SF-36) Quality of Life Physical Component</title>
          <description>Scores on the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36). Subjects completed the SF-36 which consists of 8 sub-scales ranging from 0 to 100, with (0 = worst imaginable, 100 = best imaginable).</description>
          <population>Data were available for 50, 52, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively.</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="50"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.5" spread="10.3"/>
                    <measurement group_id="O2" value="12.6" spread="9.1"/>
                    <measurement group_id="O3" value="12.3" spread="8.8"/>
                  </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>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.986</p_value>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Baseline vs 3 months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>t-test, 1 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Baseline vs 3 months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>t-test, 1 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Baseline vs 3 months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>&lt;0.001</p_value>
            <method>t-test, 1 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change in Short Form-36 (SF-36) Quality of Life Mental Component</title>
        <description>Scores on the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36). Subjects completed the SF-36 which consists of 8 sub-scales ranging from 0 to 100, with (0 = worst imaginable, 100 = best imaginable).</description>
        <time_frame>Baseline, 3 months</time_frame>
        <population>Data were available for 50, 52, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively.</population>
        <group_list>
          <group group_id="O1">
            <title>PNB Bupivacaine</title>
            <description>Bupivacaine 0.5% with 1:200,000 epinephrine 30 ml bolus preoperatively followed by an infusion of bupivacaine 0.2% on post anesthesia care unit (PACU) arrival.&#xD;
PNB Bupivacaine: Infusion&#xD;
Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg</description>
          </group>
          <group group_id="O2">
            <title>PAI Ropivacaine</title>
            <description>Patients 50 to 74.9 kg: ropivacaine 200 mg, epinephrine 100 ug, ketorolac 30 mg. Patients 75 to 99.9 kg: ropivacaine 300 mg, epinephrine 200 ug, ketorolac 30 mg. Patients 100 to 125 kg: ropivacaine 400 mg, epinephrine 300 ug, ketorolac 30mg.&#xD;
PAI Ropivacaine: Injection&#xD;
Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg&#xD;
Ketorolac: Injection, 30 mg</description>
          </group>
          <group group_id="O3">
            <title>PAI Liposomal Bupivacaine</title>
            <description>Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug.&#xD;
PAI liposomal bupivacaine: Injection&#xD;
Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg&#xD;
Ketorolac: Injection, 30 mg</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Short Form-36 (SF-36) Quality of Life Mental Component</title>
          <description>Scores on the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36). Subjects completed the SF-36 which consists of 8 sub-scales ranging from 0 to 100, with (0 = worst imaginable, 100 = best imaginable).</description>
          <population>Data were available for 50, 52, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively.</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="50"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.2" spread="9.5"/>
                    <measurement group_id="O2" value="2.6" spread="9.4"/>
                    <measurement group_id="O3" value="3.0" spread="9.4"/>
                  </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>O3</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.898</p_value>
            <method>ANOVA</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
            </group_id_list>
            <groups_desc>Baseline vs 3 months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.112</p_value>
            <method>t-test, 1 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Baseline vs 3 months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.046</p_value>
            <method>t-test, 1 sided</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Baseline vs 3 months</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.026</p_value>
            <method>t-test, 1 sided</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants Reporting Complications Since Surgery</title>
        <description>Complications were collected by telephone interview after surgery.</description>
        <time_frame>Post-operative Day 1 Through 3 - Month Follow-up</time_frame>
        <population>Data were available for 50, 54, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively.</population>
        <group_list>
          <group group_id="O1">
            <title>PNB Bupivacaine</title>
            <description>Bupivacaine 0.5% with 1:200,000 epinephrine 30 ml bolus preoperatively followed by an infusion of bupivacaine 0.2% on post anesthesia care unit (PACU) arrival.&#xD;
PNB Bupivacaine: Infusion&#xD;
Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg</description>
          </group>
          <group group_id="O2">
            <title>PAI Ropivacaine</title>
            <description>Patients 50 to 74.9 kg: ropivacaine 200 mg, epinephrine 100 ug, ketorolac 30 mg. Patients 75 to 99.9 kg: ropivacaine 300 mg, epinephrine 200 ug, ketorolac 30 mg. Patients 100 to 125 kg: ropivacaine 400 mg, epinephrine 300 ug, ketorolac 30mg.&#xD;
PAI Ropivacaine: Injection&#xD;
Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg&#xD;
Ketorolac: Injection, 30 mg</description>
          </group>
          <group group_id="O3">
            <title>PAI Liposomal Bupivacaine</title>
            <description>Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug.&#xD;
PAI liposomal bupivacaine: Injection&#xD;
Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg&#xD;
Ketorolac: Injection, 30 mg</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting Complications Since Surgery</title>
          <description>Complications were collected by telephone interview after surgery.</description>
          <population>Data were available for 50, 54, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="54"/>
                <count group_id="O3" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Operative extremity neurologic changes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Wound infection</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Fall requiring medical attention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                    <measurement group_id="O2" value="2"/>
                    <measurement group_id="O3" value="1"/>
                  </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>O3</group_id>
            </group_id_list>
            <groups_desc>Operative extremity neurologic changes</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.843</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Wound infection</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>1.00</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Fall requiring medical attention</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>1.00</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Number of Participants Reporting a NRS Pain Score Greater Than 3</title>
        <description>Pain was measured on an ascending numeric rating scale (NRS) from 0-10 where 1-3 equaled mild pain, 4-6 equaled moderate pain, 7-9 equaled severe pain, and 10 equaled worst possible pain.</description>
        <time_frame>3 month follow up</time_frame>
        <population>Data were available for 50, 54, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively.</population>
        <group_list>
          <group group_id="O1">
            <title>PNB Bupivacaine</title>
            <description>Bupivacaine 0.5% with 1:200,000 epinephrine 30 ml bolus preoperatively followed by an infusion of bupivacaine 0.2% on post anesthesia care unit (PACU) arrival.&#xD;
PNB Bupivacaine: Infusion&#xD;
Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg</description>
          </group>
          <group group_id="O2">
            <title>PAI Ropivacaine</title>
            <description>Patients 50 to 74.9 kg: ropivacaine 200 mg, epinephrine 100 ug, ketorolac 30 mg. Patients 75 to 99.9 kg: ropivacaine 300 mg, epinephrine 200 ug, ketorolac 30 mg. Patients 100 to 125 kg: ropivacaine 400 mg, epinephrine 300 ug, ketorolac 30mg.&#xD;
PAI Ropivacaine: Injection&#xD;
Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg&#xD;
Ketorolac: Injection, 30 mg</description>
          </group>
          <group group_id="O3">
            <title>PAI Liposomal Bupivacaine</title>
            <description>Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug.&#xD;
PAI liposomal bupivacaine: Injection&#xD;
Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg&#xD;
Ketorolac: Injection, 30 mg</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting a NRS Pain Score Greater Than 3</title>
          <description>Pain was measured on an ascending numeric rating scale (NRS) from 0-10 where 1-3 equaled mild pain, 4-6 equaled moderate pain, 7-9 equaled severe pain, and 10 equaled worst possible pain.</description>
          <population>Data were available for 50, 54, and 51 patients in the PNB, PAI Ropivacaine, and PAI liposomal bupivacaine groups, respectively.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="50"/>
                <count group_id="O2" value="54"/>
                <count group_id="O3" value="51"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pain at rest</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="1"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Pain with movement</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="4"/>
                    <measurement group_id="O3" value="2"/>
                  </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>O3</group_id>
            </group_id_list>
            <groups_desc>Pain at rest</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>1.00</p_value>
            <method>Fisher Exact</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Pain with movement</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.167</p_value>
            <method>Fisher Exact</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse event data were collected over the duration of the study, from baseline through three month follow-up for each study participant.</time_frame>
      <desc>The Anesthesia Clinical Research Unit (ACRU) not affiliated with the investigator team had continuous access to information regarding adverse outcomes and monitored quarterly reporting to the principal investigator. Participants were postoperatively monitored for adverse outcomes by the inpatient pain service (IPS) or surgical team.</desc>
      <group_list>
        <group group_id="E1">
          <title>PNB Bupivacaine</title>
          <description>Bupivacaine 0.5% with 1:200,000 epinephrine 30 ml bolus preoperatively followed by an infusion of bupivacaine 0.2% on post anesthesia care unit (PACU) arrival.&#xD;
PNB Bupivacaine: Infusion&#xD;
Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg</description>
        </group>
        <group group_id="E2">
          <title>PAI Ropivacaine</title>
          <description>Patients 50 to 74.9 kg: ropivacaine 200 mg, epinephrine 100 ug, ketorolac 30 mg. Patients 75 to 99.9 kg: ropivacaine 300 mg, epinephrine 200 ug, ketorolac 30 mg. Patients 100 to 125 kg: ropivacaine 400 mg, epinephrine 300 ug, ketorolac 30mg.&#xD;
PAI Ropivacaine: Injection&#xD;
Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg&#xD;
Ketorolac: Injection, 30 mg</description>
        </group>
        <group group_id="E3">
          <title>PAI Liposomal Bupivacaine</title>
          <description>Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug.&#xD;
PAI liposomal bupivacaine: Injection&#xD;
Epinephrine: Injection, weight-based dosage of 100 mcg - 300 mcg&#xD;
Ketorolac: Injection, 30 mg</description>
        </group>
      </group_list>
      <serious_events>
        <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="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="51"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="54"/>
                <counts group_id="E3" subjects_affected="1" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Infection</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>ICU admission</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="54"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="54"/>
              </event>
              <event>
                <sub_title>Rapid response team</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="54"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Nerve Injury</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="54"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Additional surgery</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="51"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="54"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="54"/>
              </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>PNB and PAI for total hip arthroplasty are highly technique dependent modalities and standardized delivery of PAI injections is less established than PNB.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Rebecca L. Johnson</name_or_title>
      <organization>Mayo Clinic</organization>
      <phone>507-266-2049</phone>
      <email>Johnson.Rebecca1@mayo.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/NCT02242201
org study id: 14-004183
secondary id: UL1TR000135
nct id: NCT02242201
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: Yes
Total hip arthroplasty is a one of the most commonly performed surgical procedures with
      increasing numbers anticipated over the next several decades. The purpose of this study was
      to find a better way to make patients comfortable after their hip surgery. Three different
      ways of providing pain relief were compared, a peripheral nerve block in the lower back
      outside of the spinal space (using bupivacaine, a numbing medicine), or injections around the
      hip joint with one of two different medicines, either Ropivacaine or Liposomal Bupivacaine
      (Exparel®).
Total hip arthroplasty is associated with moderate to severe postoperative pain and an ideal
      clinical pathway for pain management has yet to be established. Multimodal pain management
      incorporating the use of regional anesthesia for THA has led to decreased hospital length of
      stay, improved patient comfort, and enhanced patient satisfaction that is efficacious and
      cost-effective. This investigation compared multimodal total joint arthroplasty pathways with
      continuous lumbar plexus blockade versus two different periarticular injection mixtures to
      potentially determine an ideal perioperative analgesia pathway for THA.

      Patients undergoing elective, unilateral primary total hip arthroplasty within a clinical
      pathway utilizing preemptive low-dose opioid and non-opioid medications for multimodal
      analgesia were randomized to one of three different intervention groups after informed
      consent was obtained: posterior lumbar plexus block (PNB), periarticular infiltration (PAI)
      with ropivacaine, ketorolac, and epinephrine, and PAI with liposomal bupivacaine, ketorolac,
      and epinephrine. The investigators hypothesized differences in the analgesia outcomes between
      the three intervention groups would provide for an evidenced-based clinical pathway to emerge
      as a result of this study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Maximum Postoperative Pain Score
time frame: Post-Operative Day 1 (0600-1200)
description: Pain was measured on an ascending numeric rating scale (NRS) from 0-10 where 1-3 equaled mild pain, 4-6 equaled moderate pain, 7-9 equaled severe pain, and 10 equaled worst possible pain.
measure: Total Opioid Consumption During Hospitalization
time frame: Preoperative, Intraoperative, Postanesthesia Care Unit (PACU), Post Operative Day (POD) 0, day 1, and day 2
description: Measured in daily oral morphine equivalents (OME)
measure: Hospital Length of Stay
time frame: Post-operative Day 1 through discharge (approximately 3 days)
description: Discharge readiness was evaluated by the surgical team during morning and afternoon physical therapy sessions.
measure: Change in Unipedal Stance Time
time frame: Baseline, 3 months
description: Length of time in seconds a patient could stand on involved leg
measure: Post-Operative Pain Score
time frame: 3 month follow-up
description: Pain intensity (NRS) assessment at 3 month follow-up. Pain was measured on an ascending numeric rating scale (NRS) from 0-10 where 1-3 equaled mild pain, 4-6 equaled moderate pain, 7-9 equaled severe pain, and 10 equaled worst possible pain.
measure: Change in Short Form-36 (SF-36) Quality of Life Physical Component
time frame: Baseline, 3 months
description: Scores on the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36). Subjects completed the SF-36 which consists of 8 sub-scales ranging from 0 to 100, with (0 = worst imaginable, 100 = best imaginable).
measure: Change in Short Form-36 (SF-36) Quality of Life Mental Component
time frame: Baseline, 3 months
description: Scores on the Medical Outcomes Study 36-Item Short-Form General Health Survey (SF-36). Subjects completed the SF-36 which consists of 8 sub-scales ranging from 0 to 100, with (0 = worst imaginable, 100 = best imaginable).
measure: Number of Participants Reporting Complications Since Surgery
time frame: Post-operative Day 1 Through 3 - Month Follow-up
description: Complications were collected by telephone interview after surgery.
measure: Number of Participants Reporting a NRS Pain Score Greater Than 3
time frame: 3 month follow up
description: Pain was measured on an ascending numeric rating scale (NRS) from 0-10 where 1-3 equaled mild pain, 4-6 equaled moderate pain, 7-9 equaled severe pain, and 10 equaled worst possible pain.
arm group label: PNB Bupivacaine
arm group type: Active Comparator
description: Bupivacaine 0.5% with 1:200,000 epinephrine 30 ml bolus preoperatively followed by an infusion of bupivacaine 0.2% on post anesthesia care unit (PACU) arrival.
arm group label: PAI Ropivacaine
arm group type: Active Comparator
description: Patients 50 to 74.9 kg: ropivacaine 200 mg, epinephrine 100 ug, ketorolac 30 mg. Patients 75 to 99.9 kg: ropivacaine 300 mg, epinephrine 200 ug, ketorolac 30 mg. Patients 100 to 125 kg: ropivacaine 400 mg, epinephrine 300 ug, ketorolac 30mg.
arm group label: PAI liposomal bupivacaine
arm group type: Active Comparator
description: Liposomal bupivacaine 255 mg, ketorolac 30 mg, bupivacaine 125 mg, epinephrine 125 ug.
intervention type: Drug
intervention name: PNB Bupivacaine
description: Infusion
arm group label: PNB Bupivacaine
other name: Marcaine
intervention type: Drug
intervention name: PAI Ropivacaine
description: Injection
arm group label: PAI Ropivacaine
other name: Naropin
intervention type: Drug
intervention name: PAI liposomal bupivacaine
description: Injection
arm group label: PAI liposomal bupivacaine
other name: Exparel
intervention type: Drug
intervention name: Epinephrine
description: Injection, weight-based dosage of 100 mcg - 300 mcg
arm group label: PAI Ropivacaine
arm group label: PAI liposomal bupivacaine
arm group label: PNB Bupivacaine
intervention type: Drug
intervention name: Ketorolac
description: Injection, 30 mg
arm group label: PAI Ropivacaine
arm group label: PAI liposomal bupivacaine
other name: Acuvail
other name: Acular
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Rebecca Johnson, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
citation: Johnson RL, Amundson AW, Abdel MP, Sviggum HP, Mabry TM, Mantilla CB, Schroeder DR, Pagnano MW, Kopp SL. Continuous Posterior Lumbar Plexus Nerve Block Versus Periarticular Injection with Ropivacaine or Liposomal Bupivacaine for Total Hip Arthroplasty: A Three-Arm Randomized Clinical Trial. J Bone Joint Surg Am. 2017 Nov 1;99(21):1836-1845. doi: 10.2106/JBJS.16.01305.
PMID: 29088038
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Rebecca L Johnson, MD
investigator title: PI
mesh term: Ketorolac
mesh term: Epinephrine
mesh term: Bupivacaine
mesh term: Ropivacaine
sharing ipd: Undecided
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: PNB and PAI for total hip arthroplasty are highly technique dependent modalities and standardized delivery of PAI injections is less established than PNB.
point of contact: 