<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/NCT02223364</url>
  </required_header>
  <id_info>
    <org_study_id>14-002083</org_study_id>
    <nct_id>NCT02223364</nct_id>
  </id_info>
  <brief_title>Peripheral Nerve Blocks vs Periarticular Local Anesthetic Injection for Total Knee Arthroplasty (TKA)</brief_title>
  <official_title>Prospective, Randomized, Controlled Trial Comparing Continuous Femoral and Single Injection Sciatic Peripheral Nerve Blocks vs Periarticular Injection With Ropivacaine or Liposomal Bupivacaine (Exparel) on Patients Undergoing Total Knee 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to find a better way to make patients comfortable after their&#xD;
      knee surgery. The investigators compared three ways of providing pain relief, either by use&#xD;
      of a nerve block at the femoral and sciatic nerve areas, or with actual injections in the&#xD;
      surgical joint area with one of two different medicines, either ropivacaine or liposomal&#xD;
      bupivacaine (Exparel®). The hypothesis was that the nerve block at the femoral and sciatic&#xD;
      nerve areas would result in lower pain scores and opioid consumption than either of the two&#xD;
      injections in the surgical joint area.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum Pain Post-Operative Day (POD) 1 (Morning)</measure>
    <time_frame>Post-Operative Day 1, approximately 6 am to 12:00 pm</time_frame>
    <description>Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Average Pain Post-Postanesthesia Care Unit (PACU)</measure>
    <time_frame>Post-operative Day 0, approximately 12 pm to 12 am</time_frame>
    <description>Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Pain Post-PACU</measure>
    <time_frame>Post-operative Day 0, approximately 12 pm to 12 am</time_frame>
    <description>Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Pain POD 1 (24 Hours)</measure>
    <time_frame>POD 1, approximately 12 am to 12 am next day</time_frame>
    <description>Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Pain POD 1 (24 Hours)</measure>
    <time_frame>POD 1, approximately 12 am to 12 am next day</time_frame>
    <description>Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average Pain POD 2 (24 Hours)</measure>
    <time_frame>POD 2, approximately 12 am to 12 am next day</time_frame>
    <description>Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Pain POD 2 (24 Hours)</measure>
    <time_frame>POD 2, approximately 12 am to 12 am next day</time_frame>
    <description>Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Preoperative Daily Opioid Use</measure>
    <time_frame>baseline</time_frame>
    <description>Opioid consumption will be documented in the patient electronic medical record by the nursing staff caring for the patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative Opioid Use</measure>
    <time_frame>During the procedure, approximately 2 hours after start of the procedure</time_frame>
    <description>Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PACU Opioid Use</measure>
    <time_frame>Approximately 2 hours after entry in PACU</time_frame>
    <description>Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>POD 0 Post-PACU Opioid Use</measure>
    <time_frame>POD 0, approximately 12 pm to 12 am</time_frame>
    <description>Additional opioid medications that were taken by subjects (recorded at the same time as the time points for measuring pain). Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>POD 1 Opioid Use</measure>
    <time_frame>POD 1, approximately 12 am to 12 am next day</time_frame>
    <description>Additional opioid medications that were taken by subjects (recorded at the same time as the time points for measuring pain). Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>POD 2 Opioid Use</measure>
    <time_frame>POD 2, approximately 12 am to 12 am next day</time_frame>
    <description>Additional opioid medications that were taken by subjects (recorded at the same time as the time points for measuring pain). Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Length of Stay</measure>
    <time_frame>Approximately 3 days</time_frame>
    <description>The hospital length of stay was measured from the date of admittance until the date of discharge.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Balance Testing on Operative Leg Using Unipedal Stance Time</measure>
    <time_frame>baseline, approximately 12 weeks</time_frame>
    <description>In order to measure clinical balance, unipedal stance time (UST) was collected as an indicator of balance and fall risk. Timing (in seconds) began upon withdrawal of support and continued until the uplifted foot returned to the floor, the subject required support, or if the subject reached a time limit of 30 seconds. The best performance of three repetitions was recorded for analysis. Normative values for the UST are available. A UST threshold of 30 seconds yields a sensitivity of 95% and a specificity of 58% in identifying those with a history of falls. The first five seconds of unipedal stance is indicative of dynamic balance; inability to maintain unipedal stance for five seconds is a significant predictor of injurious falls.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">165</enrollment>
  <condition>Total Knee Arthroplasty</condition>
  <arm_group>
    <arm_group_label>Peripheral Nerve Block (PNB)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ropivacaine (PAI-R)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Liposomal Bupivacaine (PAI-L)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Peripheral nerve blocks with Bupivacaine</intervention_name>
    <description>Subjects received Bupivacaine 0.5% preoperatively, then Bupivacaine 0.2% upon post anesthesia care unit (PACU) arrival via femoral nerve block, then Bupivacaine 0.25% via single-injection sciatic nerve.</description>
    <arm_group_label>Peripheral Nerve Block (PNB)</arm_group_label>
    <other_name>Marcaine</other_name>
    <other_name>Sensorcaine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intra articular injection with Ropivacaine</intervention_name>
    <description>Subjects received an intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Ropivacaine dose depended upon body weight: 50-74.9 kg: 200 mg, 75-99.9 kg: 300 mg, 100-125 kg: 400 mg.</description>
    <arm_group_label>Ropivacaine (PAI-R)</arm_group_label>
    <other_name>Naropin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Intra articular injection with liposomal bupivacaine</intervention_name>
    <description>Subjects received an intra articular injection with liposomal bupivacaine, a total volume of 120 mL injected in the periarticular structures by the surgeon. Patients weighing 50-125 kg received 266mg of Liposomal Bupivacaine.</description>
    <arm_group_label>Liposomal Bupivacaine (PAI-L)</arm_group_label>
    <other_name>Exparel</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 knee replacement.&#xD;
&#xD;
          3. No focal neurologic deficit of the surgical lower extremity.&#xD;
&#xD;
          4. Cognitively intact with the ability to sign informed consent&#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, OxyContin,&#xD;
             tramadol, ondansetron, droperidol, or dexamethasone, celecoxib&#xD;
&#xD;
          5. Major systemic medical problems such as:&#xD;
&#xD;
               -  Severe renal disorder defined as glomerular filtration rate (GFR) &lt;50 units/m2&#xD;
&#xD;
               -  Cardiovascular disorders defined as congestive heart failure (CHF) New York Heart&#xD;
                  Association (NYHA) class III-IV&#xD;
&#xD;
               -  Severe hepatic disorder defined as current or past diagnosis of acute/subacute&#xD;
                  necrosis liver, acute hepatic failure, chronic liver disease, cirrhosis (primary&#xD;
                  biliary cirrhosis), fatty liver, chronic hepatitis/toxic hepatitis, liver&#xD;
                  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 knee 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 breast feeding (women of child-bearing potential, must have 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>Sandra Kopp, 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>Amundson AW, Johnson RL, Abdel MP, Mantilla CB, Panchamia JK, Taunton MJ, Kralovec ME, Hebl JR, Schroeder DR, Pagnano MW, Kopp SL. A Three-arm Randomized Clinical Trial Comparing Continuous Femoral Plus Single-injection Sciatic Peripheral Nerve Blocks versus Periarticular Injection with Ropivacaine or Liposomal Bupivacaine for Patients Undergoing Total Knee Arthroplasty. Anesthesiology. 2017 Jun;126(6):1139-1150. doi: 10.1097/ALN.0000000000001586.</citation>
    <PMID>28234636</PMID>
  </results_reference>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 29, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2014</study_first_posted>
  <results_first_submitted>June 16, 2017</results_first_submitted>
  <results_first_submitted_qc>August 29, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">August 31, 2017</results_first_posted>
  <last_update_submitted>August 29, 2017</last_update_submitted>
  <last_update_submitted_qc>August 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 31, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Sandra (Sandy) L. Kopp, M.D.</investigator_full_name>
    <investigator_title>Associate Professor of Anesthesiology</investigator_title>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
    <mesh_term>Ropivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects were recruited at Mayo Clinic in Rochester, Minnesota from October 2014 to December 2015.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Peripheral Nerve Block (PNB)</title>
          <description>This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.</description>
        </group>
        <group group_id="P2">
          <title>Ropivacaine (PAI-R)</title>
          <description>This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.</description>
        </group>
        <group group_id="P3">
          <title>Liposomal Bupivacaine (PAI-L)</title>
          <description>This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.</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="50"/>
                <participants group_id="P2" count="55"/>
                <participants group_id="P3" count="52"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="5"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>subject expired before surgery</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>Physician Decision</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_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Peripheral Nerve Block (PNB)</title>
          <description>This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.</description>
        </group>
        <group group_id="B2">
          <title>Ropivacaine (PAI-R)</title>
          <description>This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.</description>
        </group>
        <group group_id="B3">
          <title>Liposomal Bupivacaine (PAI-L)</title>
          <description>This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.</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="50"/>
            <count group_id="B2" value="55"/>
            <count group_id="B3" value="52"/>
            <count group_id="B4" value="157"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67" spread="9"/>
                    <measurement group_id="B2" value="68" spread="8"/>
                    <measurement group_id="B3" value="67" spread="8"/>
                    <measurement group_id="B4" value="67.7" spread="8.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="34"/>
                    <measurement group_id="B3" value="27"/>
                    <measurement group_id="B4" value="86"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="25"/>
                    <measurement group_id="B4" value="71"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="55"/>
                    <measurement group_id="B3" value="52"/>
                    <measurement group_id="B4" value="157"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Maximum Pain Post-Operative Day (POD) 1 (Morning)</title>
        <description>Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.</description>
        <time_frame>Post-Operative Day 1, approximately 6 am to 12:00 pm</time_frame>
        <population>Intent-to-Treat Analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Peripheral Nerve Block (PNB)</title>
            <description>This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.</description>
          </group>
          <group group_id="O2">
            <title>Ropivacaine (PAI-R)</title>
            <description>This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.</description>
          </group>
          <group group_id="O3">
            <title>Liposomal Bupivacaine (PAI-L)</title>
            <description>This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Pain Post-Operative Day (POD) 1 (Morning)</title>
          <description>Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.</description>
          <population>Intent-to-Treat Analysis</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="55"/>
                <count group_id="O3" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3" lower_limit="1" upper_limit="6"/>
                    <measurement group_id="O2" value="4" lower_limit="2" upper_limit="6"/>
                    <measurement group_id="O3" value="4.5" lower_limit="3" upper_limit="6"/>
                  </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>0.144</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>0.016</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>0.196</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Pain Post-Postanesthesia Care Unit (PACU)</title>
        <description>Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.</description>
        <time_frame>Post-operative Day 0, approximately 12 pm to 12 am</time_frame>
        <population>Intent-to-Treat analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Peripheral Nerve Block (PNB)</title>
            <description>This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.</description>
          </group>
          <group group_id="O2">
            <title>Ropivacaine (PAI-R)</title>
            <description>This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.</description>
          </group>
          <group group_id="O3">
            <title>Liposomal Bupivacaine (PAI-L)</title>
            <description>This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Pain Post-Postanesthesia Care Unit (PACU)</title>
          <description>Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.</description>
          <population>Intent-to-Treat analysis</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="55"/>
                <count group_id="O3" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.6" lower_limit="0.0" upper_limit="2.2"/>
                    <measurement group_id="O2" value="1.7" lower_limit="0.9" upper_limit="2.5"/>
                    <measurement group_id="O3" value="2.4" lower_limit="1.1" upper_limit="3.6"/>
                  </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>0.003</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>&lt;0.001</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>0.021</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Pain Post-PACU</title>
        <description>Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.</description>
        <time_frame>Post-operative Day 0, approximately 12 pm to 12 am</time_frame>
        <population>Intent-to-Treat Analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Peripheral Nerve Block (PNB)</title>
            <description>This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.</description>
          </group>
          <group group_id="O2">
            <title>Ropivacaine (PAI-R)</title>
            <description>This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.</description>
          </group>
          <group group_id="O3">
            <title>Liposomal Bupivacaine (PAI-L)</title>
            <description>This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Pain Post-PACU</title>
          <description>Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.</description>
          <population>Intent-to-Treat Analysis</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="55"/>
                <count group_id="O3" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1" lower_limit="0" upper_limit="4"/>
                    <measurement group_id="O2" value="4" lower_limit="2" upper_limit="6"/>
                    <measurement group_id="O3" value="5" lower_limit="3" upper_limit="6"/>
                  </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>&lt;0.001</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>&lt;0.001</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>0.257</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Pain POD 1 (24 Hours)</title>
        <description>Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.</description>
        <time_frame>POD 1, approximately 12 am to 12 am next day</time_frame>
        <population>Intent-to-Treat Analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Peripheral Nerve Block (PNB)</title>
            <description>This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.</description>
          </group>
          <group group_id="O2">
            <title>Ropivacaine (PAI-R)</title>
            <description>This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.</description>
          </group>
          <group group_id="O3">
            <title>Liposomal Bupivacaine (PAI-L)</title>
            <description>This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Pain POD 1 (24 Hours)</title>
          <description>Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.</description>
          <population>Intent-to-Treat Analysis</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="55"/>
                <count group_id="O3" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.5" lower_limit="1.2" upper_limit="4.2"/>
                    <measurement group_id="O2" value="3.5" lower_limit="2.5" upper_limit="4.6"/>
                    <measurement group_id="O3" value="3.7" lower_limit="2.9" upper_limit="4.6"/>
                  </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>0.059</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>0.005</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>0.214</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Pain POD 1 (24 Hours)</title>
        <description>Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.</description>
        <time_frame>POD 1, approximately 12 am to 12 am next day</time_frame>
        <population>Intent-to-Treat Analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Peripheral Nerve Block (PNB)</title>
            <description>This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.</description>
          </group>
          <group group_id="O2">
            <title>Ropivacaine (PAI-R)</title>
            <description>This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.</description>
          </group>
          <group group_id="O3">
            <title>Liposomal Bupivacaine (PAI-L)</title>
            <description>This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Pain POD 1 (24 Hours)</title>
          <description>Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.</description>
          <population>Intent-to-Treat Analysis</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="55"/>
                <count group_id="O3" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.5" lower_limit="3" upper_limit="7"/>
                    <measurement group_id="O2" value="6" lower_limit="5" upper_limit="7"/>
                    <measurement group_id="O3" value="6" lower_limit="5" upper_limit="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>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.189</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>0.043</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>0.357</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Average Pain POD 2 (24 Hours)</title>
        <description>Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.</description>
        <time_frame>POD 2, approximately 12 am to 12 am next day</time_frame>
        <population>Intent-to-Treat Analysis. For POD 2, data are missing for 5 subjects (1 on Peripheral Nerve Block (PNB) arm, 1 on Ropivacaine (PAI-R) arm, and 3 on Liposomal Bupivacaine (PAI-L) arm).</population>
        <group_list>
          <group group_id="O1">
            <title>Peripheral Nerve Block (PNB)</title>
            <description>This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.</description>
          </group>
          <group group_id="O2">
            <title>Ropivacaine (PAI-R)</title>
            <description>This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.</description>
          </group>
          <group group_id="O3">
            <title>Liposomal Bupivacaine (PAI-L)</title>
            <description>This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.</description>
          </group>
        </group_list>
        <measure>
          <title>Average Pain POD 2 (24 Hours)</title>
          <description>Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.</description>
          <population>Intent-to-Treat Analysis. For POD 2, data are missing for 5 subjects (1 on Peripheral Nerve Block (PNB) arm, 1 on Ropivacaine (PAI-R) arm, and 3 on Liposomal Bupivacaine (PAI-L) arm).</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="49"/>
                <count group_id="O2" value="54"/>
                <count group_id="O3" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" lower_limit="2.0" upper_limit="4.2"/>
                    <measurement group_id="O2" value="3.2" lower_limit="2.4" upper_limit="4.0"/>
                    <measurement group_id="O3" value="3.5" lower_limit="2.8" upper_limit="4.3"/>
                  </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>0.958</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>0.203</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>0.132</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Pain POD 2 (24 Hours)</title>
        <description>Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.</description>
        <time_frame>POD 2, approximately 12 am to 12 am next day</time_frame>
        <population>Intent-to-Treat Analysis. For POD 2, data are missing for 5 subjects (1 on PNB arm, 1 on PAI-R arm, and 3 on PAI-L arm).</population>
        <group_list>
          <group group_id="O1">
            <title>Peripheral Nerve Block (PNB)</title>
            <description>This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.</description>
          </group>
          <group group_id="O2">
            <title>Ropivacaine (PAI-R)</title>
            <description>This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.</description>
          </group>
          <group group_id="O3">
            <title>Liposomal Bupivacaine (PAI-L)</title>
            <description>This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Pain POD 2 (24 Hours)</title>
          <description>Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.</description>
          <population>Intent-to-Treat Analysis. For POD 2, data are missing for 5 subjects (1 on PNB arm, 1 on PAI-R arm, and 3 on PAI-L arm).</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="49"/>
                <count group_id="O2" value="54"/>
                <count group_id="O3" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5" lower_limit="3" upper_limit="7"/>
                    <measurement group_id="O2" value="6" lower_limit="4" upper_limit="7"/>
                    <measurement group_id="O3" value="6" lower_limit="5" upper_limit="7"/>
                  </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>0.493</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>0.299</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>0.797</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Preoperative Daily Opioid Use</title>
        <description>Opioid consumption will be documented in the patient electronic medical record by the nursing staff caring for the patient.</description>
        <time_frame>baseline</time_frame>
        <population>Intent-to-Treat Analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Peripheral Nerve Block (PNB)</title>
            <description>This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.</description>
          </group>
          <group group_id="O2">
            <title>Ropivacaine (PAI-R)</title>
            <description>This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.</description>
          </group>
          <group group_id="O3">
            <title>Liposomal Bupivacaine (PAI-L)</title>
            <description>This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.</description>
          </group>
        </group_list>
        <measure>
          <title>Preoperative Daily Opioid Use</title>
          <description>Opioid consumption will be documented in the patient electronic medical record by the nursing staff caring for the patient.</description>
          <population>Intent-to-Treat Analysis</population>
          <units>mg oral morphine equivalents (OME)</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="55"/>
                <count group_id="O3" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15" lower_limit="0" upper_limit="15"/>
                    <measurement group_id="O2" value="15" lower_limit="0" upper_limit="15"/>
                    <measurement group_id="O3" value="15" lower_limit="1" upper_limit="15"/>
                  </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>0.571</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>0.991</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>0.496</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Intraoperative Opioid Use</title>
        <description>Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.</description>
        <time_frame>During the procedure, approximately 2 hours after start of the procedure</time_frame>
        <population>Intent-to-treat analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Peripheral Nerve Block (PNB)</title>
            <description>This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.</description>
          </group>
          <group group_id="O2">
            <title>Ropivacaine (PAI-R)</title>
            <description>This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.</description>
          </group>
          <group group_id="O3">
            <title>Liposomal Bupivacaine (PAI-L)</title>
            <description>This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.</description>
          </group>
        </group_list>
        <measure>
          <title>Intraoperative Opioid Use</title>
          <description>Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.</description>
          <population>Intent-to-treat analysis</population>
          <units>mg OME</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="55"/>
                <count group_id="O3" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10" lower_limit="5" upper_limit="15"/>
                    <measurement group_id="O2" value="10" lower_limit="5" upper_limit="15"/>
                    <measurement group_id="O3" value="10" lower_limit="7" upper_limit="20"/>
                  </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>0.807</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>0.171</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.104</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>PACU Opioid Use</title>
        <description>Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.</description>
        <time_frame>Approximately 2 hours after entry in PACU</time_frame>
        <population>Intent-to-treat analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Peripheral Nerve Block (PNB)</title>
            <description>This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.</description>
          </group>
          <group group_id="O2">
            <title>Ropivacaine (PAI-R)</title>
            <description>This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.</description>
          </group>
          <group group_id="O3">
            <title>Liposomal Bupivacaine (PAI-L)</title>
            <description>This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.</description>
          </group>
        </group_list>
        <measure>
          <title>PACU Opioid Use</title>
          <description>Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.</description>
          <population>Intent-to-treat analysis</population>
          <units>mg OME</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="55"/>
                <count group_id="O3" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <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_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>POD 0 Post-PACU Opioid Use</title>
        <description>Additional opioid medications that were taken by subjects (recorded at the same time as the time points for measuring pain). Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.</description>
        <time_frame>POD 0, approximately 12 pm to 12 am</time_frame>
        <population>Intent-to-treat</population>
        <group_list>
          <group group_id="O1">
            <title>Peripheral Nerve Block (PNB)</title>
            <description>This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.</description>
          </group>
          <group group_id="O2">
            <title>Ropivacaine (PAI-R)</title>
            <description>This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.</description>
          </group>
          <group group_id="O3">
            <title>Liposomal Bupivacaine (PAI-L)</title>
            <description>This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.</description>
          </group>
        </group_list>
        <measure>
          <title>POD 0 Post-PACU Opioid Use</title>
          <description>Additional opioid medications that were taken by subjects (recorded at the same time as the time points for measuring pain). Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.</description>
          <population>Intent-to-treat</population>
          <units>mg OME</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="55"/>
                <count group_id="O3" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="15"/>
                    <measurement group_id="O2" value="8" lower_limit="0" upper_limit="30"/>
                    <measurement group_id="O3" value="15" lower_limit="0" 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_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.012</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>&lt;0.001</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>0.293</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>POD 1 Opioid Use</title>
        <description>Additional opioid medications that were taken by subjects (recorded at the same time as the time points for measuring pain). Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.</description>
        <time_frame>POD 1, approximately 12 am to 12 am next day</time_frame>
        <population>Intent-to-treat analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Peripheral Nerve Block (PNB)</title>
            <description>This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.</description>
          </group>
          <group group_id="O2">
            <title>Ropivacaine (PAI-R)</title>
            <description>This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.</description>
          </group>
          <group group_id="O3">
            <title>Liposomal Bupivacaine (PAI-L)</title>
            <description>This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.</description>
          </group>
        </group_list>
        <measure>
          <title>POD 1 Opioid Use</title>
          <description>Additional opioid medications that were taken by subjects (recorded at the same time as the time points for measuring pain). Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.</description>
          <population>Intent-to-treat analysis</population>
          <units>mg OME</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="55"/>
                <count group_id="O3" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26" lower_limit="0" upper_limit="53"/>
                    <measurement group_id="O2" value="38" lower_limit="15" upper_limit="53"/>
                    <measurement group_id="O3" value="45" lower_limit="15" upper_limit="82"/>
                  </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>0.202</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>0.007</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>0.148</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>POD 2 Opioid Use</title>
        <description>Additional opioid medications that were taken by subjects (recorded at the same time as the time points for measuring pain). Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.</description>
        <time_frame>POD 2, approximately 12 am to 12 am next day</time_frame>
        <population>Intent-to-treat analysis. For POD 2, data are missing for 5 subjects (1 on PNB arm, 1 on PAI-R arm, and 3 on PAI-L arm).</population>
        <group_list>
          <group group_id="O1">
            <title>Peripheral Nerve Block (PNB)</title>
            <description>This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.</description>
          </group>
          <group group_id="O2">
            <title>Ropivacaine (PAI-R)</title>
            <description>This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.</description>
          </group>
          <group group_id="O3">
            <title>Liposomal Bupivacaine (PAI-L)</title>
            <description>This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.</description>
          </group>
        </group_list>
        <measure>
          <title>POD 2 Opioid Use</title>
          <description>Additional opioid medications that were taken by subjects (recorded at the same time as the time points for measuring pain). Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.</description>
          <population>Intent-to-treat analysis. For POD 2, data are missing for 5 subjects (1 on PNB arm, 1 on PAI-R arm, and 3 on PAI-L arm).</population>
          <units>mg OME</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="49"/>
                <count group_id="O2" value="54"/>
                <count group_id="O3" value="49"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23" lower_limit="0" upper_limit="38"/>
                    <measurement group_id="O2" value="15" lower_limit="0" upper_limit="38"/>
                    <measurement group_id="O3" value="23" lower_limit="15" upper_limit="45"/>
                  </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>0.933</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>0.169</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>0.126</p_value>
            <method>Wilcoxon (Mann-Whitney)</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hospital Length of Stay</title>
        <description>The hospital length of stay was measured from the date of admittance until the date of discharge.</description>
        <time_frame>Approximately 3 days</time_frame>
        <population>Intent-to-treat analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Peripheral Nerve Block (PNB)</title>
            <description>This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.</description>
          </group>
          <group group_id="O2">
            <title>Ropivacaine (PAI-R)</title>
            <description>This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.</description>
          </group>
          <group group_id="O3">
            <title>Liposomal Bupivacaine (PAI-L)</title>
            <description>This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.</description>
          </group>
        </group_list>
        <measure>
          <title>Hospital Length of Stay</title>
          <description>The hospital length of stay was measured from the date of admittance until the date of discharge.</description>
          <population>Intent-to-treat analysis</population>
          <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="50"/>
                <count group_id="O2" value="55"/>
                <count group_id="O3" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2" lower_limit="2" upper_limit="3"/>
                    <measurement group_id="O2" value="2" lower_limit="2" upper_limit="3"/>
                    <measurement group_id="O3" value="2" lower_limit="2" upper_limit="3"/>
                  </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>0.768</p_value>
            <method>Kruskal-Wallis</method>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Balance Testing on Operative Leg Using Unipedal Stance Time</title>
        <description>In order to measure clinical balance, unipedal stance time (UST) was collected as an indicator of balance and fall risk. Timing (in seconds) began upon withdrawal of support and continued until the uplifted foot returned to the floor, the subject required support, or if the subject reached a time limit of 30 seconds. The best performance of three repetitions was recorded for analysis. Normative values for the UST are available. A UST threshold of 30 seconds yields a sensitivity of 95% and a specificity of 58% in identifying those with a history of falls. The first five seconds of unipedal stance is indicative of dynamic balance; inability to maintain unipedal stance for five seconds is a significant predictor of injurious falls.</description>
        <time_frame>baseline, approximately 12 weeks</time_frame>
        <population>Intent-to-treat analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Peripheral Nerve Block (PNB)</title>
            <description>This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.</description>
          </group>
          <group group_id="O2">
            <title>Ropivacaine (PAI-R)</title>
            <description>This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.</description>
          </group>
          <group group_id="O3">
            <title>Liposomal Bupivacaine (PAI-L)</title>
            <description>This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.</description>
          </group>
        </group_list>
        <measure>
          <title>Balance Testing on Operative Leg Using Unipedal Stance Time</title>
          <description>In order to measure clinical balance, unipedal stance time (UST) was collected as an indicator of balance and fall risk. Timing (in seconds) began upon withdrawal of support and continued until the uplifted foot returned to the floor, the subject required support, or if the subject reached a time limit of 30 seconds. The best performance of three repetitions was recorded for analysis. Normative values for the UST are available. A UST threshold of 30 seconds yields a sensitivity of 95% and a specificity of 58% in identifying those with a history of falls. The first five seconds of unipedal stance is indicative of dynamic balance; inability to maintain unipedal stance for five seconds is a significant predictor of injurious falls.</description>
          <population>Intent-to-treat analysis</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="55"/>
                <count group_id="O3" value="52"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24" lower_limit="7" upper_limit="30"/>
                    <measurement group_id="O2" value="16" lower_limit="5" upper_limit="30"/>
                    <measurement group_id="O3" value="17" lower_limit="3" upper_limit="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>12 weeks</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="20" lower_limit="8" upper_limit="30"/>
                    <measurement group_id="O2" value="30" lower_limit="11" upper_limit="30"/>
                    <measurement group_id="O3" value="23" lower_limit="8" 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_list>
            <groups_desc>Within group comparison of baseline and 3 months (approximately 12 weeks)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.623</p_value>
            <method>Regression, Cox</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O2</group_id>
            </group_id_list>
            <groups_desc>Within group comparison of baseline and 3 months (approximately 12 weeks)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.001</p_value>
            <method>Regression, Cox</method>
          </analysis>
          <analysis>
            <group_id_list>
              <group_id>O3</group_id>
            </group_id_list>
            <groups_desc>Within group comparison of baseline and three months (approximately 12 weeks)</groups_desc>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.048</p_value>
            <method>Regression, Cox</method>
          </analysis>
        </analysis_list>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Peripheral Nerve Block (PNB)</title>
          <description>This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.</description>
        </group>
        <group group_id="E2">
          <title>Ropivacaine (PAI-R)</title>
          <description>This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.</description>
        </group>
        <group group_id="E3">
          <title>Liposomal Bupivacaine (PAI-L)</title>
          <description>This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.</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="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="52"/>
              </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="2" subjects_at_risk="50"/>
                <counts group_id="E2" subjects_affected="3" subjects_at_risk="55"/>
                <counts group_id="E3" subjects_affected="3" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Fall</sub_title>
                <description>2 in the peripheral nerve block group fell during their hospital stay; one in the ropivacaine periarticular injection group and one in the liposomal bupivacaine periarticular injection group fell after hospital discharge.</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Rapid Response Team</sub_title>
                <description>Adverse event occurred during the patients' hospital stay.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="50"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="55"/>
                <counts group_id="E3" events="1" subjects_affected="1" subjects_at_risk="52"/>
              </event>
              <event>
                <sub_title>Additional surgery</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="50"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Superficial wound infection</sub_title>
                <description>Six patients, two in each group experienced a superficial wound infection after hospital discharge that required treatment with antibiotics.</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="55"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Nerve Injury</sub_title>
                <description>This adverse event occurred after hospital discharge.</description>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="50"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="55"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="52"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Sandra L. Kopp</name_or_title>
      <organization>Mayo Clinic</organization>
      <phone>507-284-6637</phone>
      <email>Kopp.Sandra@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/NCT02223364
org study id: 14-002083
nct id: NCT02223364
lead sponsor: 
has dmc: No
The purpose of this study is to find a better way to make patients comfortable after their
      knee surgery. The investigators compared three ways of providing pain relief, either by use
      of a nerve block at the femoral and sciatic nerve areas, or with actual injections in the
      surgical joint area with one of two different medicines, either ropivacaine or liposomal
      bupivacaine (Exparel®). The hypothesis was that the nerve block at the femoral and sciatic
      nerve areas would result in lower pain scores and opioid consumption than either of the two
      injections in the surgical joint area.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum Pain Post-Operative Day (POD) 1 (Morning)
time frame: Post-Operative Day 1, approximately 6 am to 12:00 pm
description: Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.
measure: Average Pain Post-Postanesthesia Care Unit (PACU)
time frame: Post-operative Day 0, approximately 12 pm to 12 am
description: Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.
measure: Maximum Pain Post-PACU
time frame: Post-operative Day 0, approximately 12 pm to 12 am
description: Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.
measure: Average Pain POD 1 (24 Hours)
time frame: POD 1, approximately 12 am to 12 am next day
description: Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.
measure: Maximum Pain POD 1 (24 Hours)
time frame: POD 1, approximately 12 am to 12 am next day
description: Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.
measure: Average Pain POD 2 (24 Hours)
time frame: POD 2, approximately 12 am to 12 am next day
description: Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.
measure: Maximum Pain POD 2 (24 Hours)
time frame: POD 2, approximately 12 am to 12 am next day
description: Pain was measured on a 1-10 numeric pain rating scale (NRS) with 0=no pain, and 10=worst pain imaginable.
measure: Preoperative Daily Opioid Use
time frame: baseline
description: Opioid consumption will be documented in the patient electronic medical record by the nursing staff caring for the patient.
measure: Intraoperative Opioid Use
time frame: During the procedure, approximately 2 hours after start of the procedure
description: Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.
measure: PACU Opioid Use
time frame: Approximately 2 hours after entry in PACU
description: Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.
measure: POD 0 Post-PACU Opioid Use
time frame: POD 0, approximately 12 pm to 12 am
description: Additional opioid medications that were taken by subjects (recorded at the same time as the time points for measuring pain). Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.
measure: POD 1 Opioid Use
time frame: POD 1, approximately 12 am to 12 am next day
description: Additional opioid medications that were taken by subjects (recorded at the same time as the time points for measuring pain). Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.
measure: POD 2 Opioid Use
time frame: POD 2, approximately 12 am to 12 am next day
description: Additional opioid medications that were taken by subjects (recorded at the same time as the time points for measuring pain). Opioid consumption was documented in the patient electronic medical record by the nursing staff caring for the patient.
measure: Hospital Length of Stay
time frame: Approximately 3 days
description: The hospital length of stay was measured from the date of admittance until the date of discharge.
measure: Balance Testing on Operative Leg Using Unipedal Stance Time
time frame: baseline, approximately 12 weeks
description: In order to measure clinical balance, unipedal stance time (UST) was collected as an indicator of balance and fall risk. Timing (in seconds) began upon withdrawal of support and continued until the uplifted foot returned to the floor, the subject required support, or if the subject reached a time limit of 30 seconds. The best performance of three repetitions was recorded for analysis. Normative values for the UST are available. A UST threshold of 30 seconds yields a sensitivity of 95% and a specificity of 58% in identifying those with a history of falls. The first five seconds of unipedal stance is indicative of dynamic balance; inability to maintain unipedal stance for five seconds is a significant predictor of injurious falls.
arm group label: Peripheral Nerve Block (PNB)
arm group type: Active Comparator
description: This group received a continuous femoral nerve block and a single injection sciatic nerve block consisting of the following: Peripheral nerve blocks with Bupivacaine.
arm group label: Ropivacaine (PAI-R)
arm group type: Active Comparator
description: This group received intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
arm group label: Liposomal Bupivacaine (PAI-L)
arm group type: Active Comparator
description: This group received Intra articular injection with liposomal bupivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Following the current, standardized practice for periarticular infiltration, approximately 30 - 40 mL of solution was injected into the posterior capsule just prior to cementing the implants in place and 40 - 50 mL of solution injected into the medial and lateral retinaculum while the cement was hardening and prior to deflation of the tourniquet. The remaining volume of approximately 40 mL was injected into the quadriceps tendon and subcutaneous tissue prior to skin closure.
intervention type: Drug
intervention name: Peripheral nerve blocks with Bupivacaine
description: Subjects received Bupivacaine 0.5% preoperatively, then Bupivacaine 0.2% upon post anesthesia care unit (PACU) arrival via femoral nerve block, then Bupivacaine 0.25% via single-injection sciatic nerve.
arm group label: Peripheral Nerve Block (PNB)
other name: Marcaine
other name: Sensorcaine
intervention type: Drug
intervention name: Intra articular injection with Ropivacaine
description: Subjects received an intra articular injection with Ropivacaine, a total volume of 120 milliliters (mL) injected in the periarticular structures by the surgeon. Ropivacaine dose depended upon body weight: 50-74.9 kg: 200 mg, 75-99.9 kg: 300 mg, 100-125 kg: 400 mg.
arm group label: Ropivacaine (PAI-R)
other name: Naropin
intervention type: Drug
intervention name: Intra articular injection with liposomal bupivacaine
description: Subjects received an intra articular injection with liposomal bupivacaine, a total volume of 120 mL injected in the periarticular structures by the surgeon. Patients weighing 50-125 kg received 266mg of Liposomal Bupivacaine.
arm group label: Liposomal Bupivacaine (PAI-L)
other name: Exparel
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Sandra Kopp, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
citation: Amundson AW, Johnson RL, Abdel MP, Mantilla CB, Panchamia JK, Taunton MJ, Kralovec ME, Hebl JR, Schroeder DR, Pagnano MW, Kopp SL. A Three-arm Randomized Clinical Trial Comparing Continuous Femoral Plus Single-injection Sciatic Peripheral Nerve Blocks versus Periarticular Injection with Ropivacaine or Liposomal Bupivacaine for Patients Undergoing Total Knee Arthroplasty. Anesthesiology. 2017 Jun;126(6):1139-1150. doi: 10.1097/ALN.0000000000001586.
PMID: 28234636
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Sandra (Sandy) L. Kopp, M.D.
investigator title: Associate Professor of Anesthesiology
mesh term: Bupivacaine
mesh term: Ropivacaine
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 