<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/NCT03838874</url>
  </required_header>
  <id_info>
    <org_study_id>18-008635</org_study_id>
    <nct_id>NCT03838874</nct_id>
  </id_info>
  <brief_title>Mepivacaine Versus Low-Dose Bupivacaine For Primary Total Hip and Knee Arthroplasty</brief_title>
  <official_title>Double Blind Randomized Clinical Trial Comparing Time To Return of Lower Extremity Motor Function Following Spinal Anesthetic With Mepivacaine Versus Low-Dose Bupivacaine For Primary Total Hip and 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>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research is being done to see if there is a difference between two different spinal&#xD;
      anesthetics (Mepivacaine vs. Bupivacaine) as it relates to reducing post-operative&#xD;
      complications and the time it takes for subjects to regain mobility after surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 25, 2019</start_date>
  <completion_date type="Actual">October 29, 2019</completion_date>
  <primary_completion_date type="Actual">October 29, 2019</primary_completion_date>
  <phase>Phase 2/Phase 3</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to Return of Lower Extremity Motor Function</measure>
    <time_frame>Post surgery, approximately 1 day</time_frame>
    <description>Assessed by measuring time from spinal anesthetic administration to postoperative achievement of Bromage 0 function (return of spontaneous ankle, knee, and hip movement) in the non-operative extremity at 15-minute intervals.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post-Anesthesia Care Unit (PACU) Length of Stay</measure>
    <time_frame>Time of discharge, approximately 1-2 days</time_frame>
    <description>Number of minutes subjects were admitted to PACU following the surgical procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Length of Stay</measure>
    <time_frame>Time of discharge, approximately 1-2 days</time_frame>
    <description>Number days subjects were admitted to the hospital following the surgical procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Maximum Pain Score</measure>
    <time_frame>24 hours following the surgical procedure</time_frame>
    <description>Measured on a scale from 1 to 10 in the first 24 hours following the surgical procedure, 1=mild pain; 10=worst pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Pain Score</measure>
    <time_frame>24 hours following the surgical procedure</time_frame>
    <description>Measured on a scale from 1 to 10 in the first 24 hours following the surgical procedure, 1=mild pain; 10=worst pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Discharge Pain Score</measure>
    <time_frame>Time of discharge, approximately 1-2 days</time_frame>
    <description>Measured on a scale from 1 to 10 at time of hospital discharge, 1=mild pain; 10=worst pain.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Orthostatic Hypotension</measure>
    <time_frame>Time of discharge, approximately 1-2 days</time_frame>
    <description>Number of participants to experience orthostatic hypotension following the surgical procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary Retention</measure>
    <time_frame>Time of discharge, approximately 1-2 days</time_frame>
    <description>Number of participants to experience urinary retention follow the surgical procedure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transient Neurologic Symptoms</measure>
    <time_frame>One week post-operative</time_frame>
    <description>Number of participants to report transient neurologic symptoms</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">154</enrollment>
  <condition>Knee Osteoarthritis</condition>
  <condition>Hip Osteoarthritis</condition>
  <arm_group>
    <arm_group_label>Low-Dose Bupivacaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects in this group will be given 10mg of Low-Dose Bupivacaine, which is within standard of care for spinal anesthesia during TKA or THA.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mepivacaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Subjects in this group will be given 70mg of Mepivacaine, which is within standard of care for spinal anesthesia during TKA or THA.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Low-Dose Bupivacaine</intervention_name>
    <description>10 mg (2 mL of 0.5%) administered as an isobaric spinal anesthetic</description>
    <arm_group_label>Low-Dose Bupivacaine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mepivacaine</intervention_name>
    <description>70 mg (3.5 mL of 2%) administered as an isobaric spinal anesthetic</description>
    <arm_group_label>Mepivacaine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) physiological status I-III (patient must&#xD;
             meet criteria of a status I-III in the ASA Physical Status Classification System:&#xD;
             I=Normal Healthy Patient, II=Mild Systemic Disease, and III=Severe Systemic Disease)&#xD;
&#xD;
          -  Unilateral primary TKA or THA&#xD;
&#xD;
          -  18+ years of age&#xD;
&#xD;
          -  Able to provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic pain syndromes such as fibromyalgia or complex regional pain syndrome&#xD;
&#xD;
          -  Chronic opioid use (&gt;1 mos) with OME &gt;5 mg/day OR acute opioid use (&lt; 1 mos) with OME&#xD;
             &gt; 30 mg/day.&#xD;
&#xD;
          -  Body mass index (BMI) &gt; 45 kg/m2&#xD;
&#xD;
          -  Severe drug allergy* to medications used in this study, including non-steroidal&#xD;
             anti-inflammatory drugs (i.e. celecoxib and ketorolac), and local anesthetics (defined&#xD;
             as an immune reaction resulting in shortness of breath, hives, anaphylaxis, wheezing,&#xD;
             and fever)&#xD;
&#xD;
          -  Major systemic medical comorbidities such as:&#xD;
&#xD;
               -  Pre-existing severe renal disorder defined as glomerular filtration rate (GFR)&#xD;
                  &lt;50 units/m2 (if labs are available), currently on dialysis, or highly suspected&#xD;
                  based on history.&#xD;
&#xD;
               -  Severe hepatic disorder defined as current or past diagnosis of acute/subacute&#xD;
                  necrosis of liver, acute hepatic failure, chronic liver disease, cirrhosis&#xD;
                  (primary biliary cirrhosis), chronic hepatitis/toxic hepatitis, liver abscess,&#xD;
                  hepatic coma, hepatorenal syndrome, other disorders of liver&#xD;
&#xD;
          -  Contraindication to spinal anesthesia technique (e.g., known spinal stenosis,&#xD;
             coagulopathy, sepsis, infection at site of injection, uncooperative, refusal,&#xD;
             anticoagulation medications not held within appropriate time frame*). *Per ASRA&#xD;
             guidelines, Clopidogrel (Plavix) held for at least 7 days, Dabigatran (Pradexa) held&#xD;
             for at least 5 days, Rivaroxaban (Xarelto)held for at least 3 days, Warfarin&#xD;
             (Coumadin)held for at least 5 days or recent INR of less than 1.4, Enoxaparin&#xD;
             (Lovenox) with doses &gt; 1 mg/kg held for close to 24 hours.&#xD;
&#xD;
          -  Known to be currently pregnant or actively breastfeeding. Patients that have a&#xD;
             previous history of menopause, hysterectomy, or tubal ligation will not be required to&#xD;
             perform a pregnancy test. Female patients that do not meet this criterion will be&#xD;
             asked to submit a urine sample, and will require a negative urine sample in order to&#xD;
             proceed with study protocol. Urine sample be collected pre-procedurally.&#xD;
&#xD;
          -  Impaired cognition&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Days</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Matthew P Abdel, 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>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>February 11, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 12, 2019</study_first_posted>
  <results_first_submitted>June 30, 2021</results_first_submitted>
  <results_first_submitted_qc>July 20, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">August 12, 2021</results_first_posted>
  <last_update_submitted>July 20, 2021</last_update_submitted>
  <last_update_submitted_qc>July 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">August 12, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Matthew P. Abdel, M.D.</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteoarthritis</mesh_term>
    <mesh_term>Osteoarthritis, Hip</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
    <mesh_term>Mepivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 3, 2018</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/74/NCT03838874/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Low-Dose Bupivacaine</title>
          <description>Subjects in this group will be given 10mg of Low-Dose Bupivacaine, which is within standard of care for spinal anesthesia during TKA or THA.&#xD;
Low-Dose Bupivacaine: 10 mg (2 mL of 0.5%) administered as an isobaric spinal anesthetic</description>
        </group>
        <group group_id="P2">
          <title>Mepivacaine</title>
          <description>Subjects in this group will be given 70mg of Mepivacaine, which is within standard of care for spinal anesthesia during TKA or THA.&#xD;
Mepivacaine: 70 mg (3.5 mL of 2%) administered as an isobaric spinal anesthetic</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="80"/>
                <participants group_id="P2" count="74"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="80"/>
                <participants group_id="P2" count="74"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Low-Dose Bupivacaine</title>
          <description>Subjects in this group will be given 10mg of Low-Dose Bupivacaine, which is within standard of care for spinal anesthesia during TKA or THA.&#xD;
Low-Dose Bupivacaine: 10 mg (2 mL of 0.5%) administered as an isobaric spinal anesthetic</description>
        </group>
        <group group_id="B2">
          <title>Mepivacaine</title>
          <description>Subjects in this group will be given 70mg of Mepivacaine, which is within standard of care for spinal anesthesia during TKA or THA.&#xD;
Mepivacaine: 70 mg (3.5 mL of 2%) administered as an isobaric spinal anesthetic</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="80"/>
            <count group_id="B2" value="74"/>
            <count group_id="B3" value="154"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="80"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="154"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67.9" spread="11.8"/>
                    <measurement group_id="B2" value="67.9" spread="9.2"/>
                    <measurement group_id="B3" value="67.9" spread="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="80"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="154"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                    <measurement group_id="B2" value="42"/>
                    <measurement group_id="B3" value="88"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="34"/>
                    <measurement group_id="B2" value="32"/>
                    <measurement group_id="B3" value="66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="80"/>
                    <count group_id="B2" value="74"/>
                    <count group_id="B3" value="154"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="80"/>
                    <measurement group_id="B2" value="74"/>
                    <measurement group_id="B3" value="154"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Time to Return of Lower Extremity Motor Function</title>
        <description>Assessed by measuring time from spinal anesthetic administration to postoperative achievement of Bromage 0 function (return of spontaneous ankle, knee, and hip movement) in the non-operative extremity at 15-minute intervals.</description>
        <time_frame>Post surgery, approximately 1 day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low-Dose Bupivacaine</title>
            <description>Subjects in this group will be given 10mg of Low-Dose Bupivacaine, which is within standard of care for spinal anesthesia during TKA or THA.&#xD;
Low-Dose Bupivacaine: 10 mg (2 mL of 0.5%) administered as an isobaric spinal anesthetic</description>
          </group>
          <group group_id="O2">
            <title>Mepivacaine</title>
            <description>Subjects in this group will be given 70mg of Mepivacaine, which is within standard of care for spinal anesthesia during TKA or THA.&#xD;
Mepivacaine: 70 mg (3.5 mL of 2%) administered as an isobaric spinal anesthetic</description>
          </group>
        </group_list>
        <measure>
          <title>Time to Return of Lower Extremity Motor Function</title>
          <description>Assessed by measuring time from spinal anesthetic administration to postoperative achievement of Bromage 0 function (return of spontaneous ankle, knee, and hip movement) in the non-operative extremity at 15-minute intervals.</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="210.3" spread="79.54"/>
                    <measurement group_id="O2" value="184.7" spread="47.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Post-Anesthesia Care Unit (PACU) Length of Stay</title>
        <description>Number of minutes subjects were admitted to PACU following the surgical procedure</description>
        <time_frame>Time of discharge, approximately 1-2 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low-Dose Bupivacaine</title>
            <description>Subjects in this group will be given 10mg of Low-Dose Bupivacaine, which is within standard of care for spinal anesthesia during TKA or THA.&#xD;
Low-Dose Bupivacaine: 10 mg (2 mL of 0.5%) administered as an isobaric spinal anesthetic</description>
          </group>
          <group group_id="O2">
            <title>Mepivacaine</title>
            <description>Subjects in this group will be given 70mg of Mepivacaine, which is within standard of care for spinal anesthesia during TKA or THA.&#xD;
Mepivacaine: 70 mg (3.5 mL of 2%) administered as an isobaric spinal anesthetic</description>
          </group>
        </group_list>
        <measure>
          <title>Post-Anesthesia Care Unit (PACU) Length of Stay</title>
          <description>Number of minutes subjects were admitted to PACU following the surgical procedure</description>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="65.2" spread="33.6"/>
                    <measurement group_id="O2" value="75.0" spread="39.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hospital Length of Stay</title>
        <description>Number days subjects were admitted to the hospital following the surgical procedure</description>
        <time_frame>Time of discharge, approximately 1-2 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low-Dose Bupivacaine</title>
            <description>Subjects in this group will be given 10mg of Low-Dose Bupivacaine, which is within standard of care for spinal anesthesia during TKA or THA.&#xD;
Low-Dose Bupivacaine: 10 mg (2 mL of 0.5%) administered as an isobaric spinal anesthetic</description>
          </group>
          <group group_id="O2">
            <title>Mepivacaine</title>
            <description>Subjects in this group will be given 70mg of Mepivacaine, which is within standard of care for spinal anesthesia during TKA or THA.&#xD;
Mepivacaine: 70 mg (3.5 mL of 2%) administered as an isobaric spinal anesthetic</description>
          </group>
        </group_list>
        <measure>
          <title>Hospital Length of Stay</title>
          <description>Number days subjects were admitted to the hospital following the surgical procedure</description>
          <units>days</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.5" spread="0.9"/>
                    <measurement group_id="O2" value="1.4" spread="0.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Maximum Pain Score</title>
        <description>Measured on a scale from 1 to 10 in the first 24 hours following the surgical procedure, 1=mild pain; 10=worst pain.</description>
        <time_frame>24 hours following the surgical procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low-Dose Bupivacaine</title>
            <description>Subjects in this group will be given 10mg of Low-Dose Bupivacaine, which is within standard of care for spinal anesthesia during TKA or THA.&#xD;
Low-Dose Bupivacaine: 10 mg (2 mL of 0.5%) administered as an isobaric spinal anesthetic</description>
          </group>
          <group group_id="O2">
            <title>Mepivacaine</title>
            <description>Subjects in this group will be given 70mg of Mepivacaine, which is within standard of care for spinal anesthesia during TKA or THA.&#xD;
Mepivacaine: 70 mg (3.5 mL of 2%) administered as an isobaric spinal anesthetic</description>
          </group>
        </group_list>
        <measure>
          <title>Maximum Pain Score</title>
          <description>Measured on a scale from 1 to 10 in the first 24 hours following the surgical procedure, 1=mild pain; 10=worst pain.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.0" spread="2.5"/>
                    <measurement group_id="O2" value="6.5" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Pain Score</title>
        <description>Measured on a scale from 1 to 10 in the first 24 hours following the surgical procedure, 1=mild pain; 10=worst pain.</description>
        <time_frame>24 hours following the surgical procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low-Dose Bupivacaine</title>
            <description>Subjects in this group will be given 10mg of Low-Dose Bupivacaine, which is within standard of care for spinal anesthesia during TKA or THA.&#xD;
Low-Dose Bupivacaine: 10 mg (2 mL of 0.5%) administered as an isobaric spinal anesthetic</description>
          </group>
          <group group_id="O2">
            <title>Mepivacaine</title>
            <description>Subjects in this group will be given 70mg of Mepivacaine, which is within standard of care for spinal anesthesia during TKA or THA.&#xD;
Mepivacaine: 70 mg (3.5 mL of 2%) administered as an isobaric spinal anesthetic</description>
          </group>
        </group_list>
        <measure>
          <title>Median Pain Score</title>
          <description>Measured on a scale from 1 to 10 in the first 24 hours following the surgical procedure, 1=mild pain; 10=worst pain.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.4" spread="1.9"/>
                    <measurement group_id="O2" value="3.4" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Discharge Pain Score</title>
        <description>Measured on a scale from 1 to 10 at time of hospital discharge, 1=mild pain; 10=worst pain.</description>
        <time_frame>Time of discharge, approximately 1-2 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low-Dose Bupivacaine</title>
            <description>Subjects in this group will be given 10mg of Low-Dose Bupivacaine, which is within standard of care for spinal anesthesia during TKA or THA.&#xD;
Low-Dose Bupivacaine: 10 mg (2 mL of 0.5%) administered as an isobaric spinal anesthetic</description>
          </group>
          <group group_id="O2">
            <title>Mepivacaine</title>
            <description>Subjects in this group will be given 70mg of Mepivacaine, which is within standard of care for spinal anesthesia during TKA or THA.&#xD;
Mepivacaine: 70 mg (3.5 mL of 2%) administered as an isobaric spinal anesthetic</description>
          </group>
        </group_list>
        <measure>
          <title>Discharge Pain Score</title>
          <description>Measured on a scale from 1 to 10 at time of hospital discharge, 1=mild pain; 10=worst pain.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.5" spread="2.1"/>
                    <measurement group_id="O2" value="3.5" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Orthostatic Hypotension</title>
        <description>Number of participants to experience orthostatic hypotension following the surgical procedure.</description>
        <time_frame>Time of discharge, approximately 1-2 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low-Dose Bupivacaine</title>
            <description>Subjects in this group will be given 10mg of Low-Dose Bupivacaine, which is within standard of care for spinal anesthesia during TKA or THA.&#xD;
Low-Dose Bupivacaine: 10 mg (2 mL of 0.5%) administered as an isobaric spinal anesthetic</description>
          </group>
          <group group_id="O2">
            <title>Mepivacaine</title>
            <description>Subjects in this group will be given 70mg of Mepivacaine, which is within standard of care for spinal anesthesia during TKA or THA.&#xD;
Mepivacaine: 70 mg (3.5 mL of 2%) administered as an isobaric spinal anesthetic</description>
          </group>
        </group_list>
        <measure>
          <title>Orthostatic Hypotension</title>
          <description>Number of participants to experience orthostatic hypotension following the surgical procedure.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Urinary Retention</title>
        <description>Number of participants to experience urinary retention follow the surgical procedure.</description>
        <time_frame>Time of discharge, approximately 1-2 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low-Dose Bupivacaine</title>
            <description>Subjects in this group will be given 10mg of Low-Dose Bupivacaine, which is within standard of care for spinal anesthesia during TKA or THA.&#xD;
Low-Dose Bupivacaine: 10 mg (2 mL of 0.5%) administered as an isobaric spinal anesthetic</description>
          </group>
          <group group_id="O2">
            <title>Mepivacaine</title>
            <description>Subjects in this group will be given 70mg of Mepivacaine, which is within standard of care for spinal anesthesia during TKA or THA.&#xD;
Mepivacaine: 70 mg (3.5 mL of 2%) administered as an isobaric spinal anesthetic</description>
          </group>
        </group_list>
        <measure>
          <title>Urinary Retention</title>
          <description>Number of participants to experience urinary retention follow the surgical procedure.</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="10"/>
                    <measurement group_id="O2" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Transient Neurologic Symptoms</title>
        <description>Number of participants to report transient neurologic symptoms</description>
        <time_frame>One week post-operative</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low-Dose Bupivacaine</title>
            <description>Subjects in this group will be given 10mg of Low-Dose Bupivacaine, which is within standard of care for spinal anesthesia during TKA or THA.&#xD;
Low-Dose Bupivacaine: 10 mg (2 mL of 0.5%) administered as an isobaric spinal anesthetic</description>
          </group>
          <group group_id="O2">
            <title>Mepivacaine</title>
            <description>Subjects in this group will be given 70mg of Mepivacaine, which is within standard of care for spinal anesthesia during TKA or THA.&#xD;
Mepivacaine: 70 mg (3.5 mL of 2%) administered as an isobaric spinal anesthetic</description>
          </group>
        </group_list>
        <measure>
          <title>Transient Neurologic Symptoms</title>
          <description>Number of participants to report transient neurologic symptoms</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="80"/>
                <count group_id="O2" value="74"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were collected from baseline to end of study for a total of approximately 6-9 days on all participants.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Low-Dose Bupivacaine</title>
          <description>Subjects in this group will be given 10mg of Low-Dose Bupivacaine, which is within standard of care for spinal anesthesia during TKA or THA.&#xD;
Low-Dose Bupivacaine: 10 mg (2 mL of 0.5%) administered as an isobaric spinal anesthetic</description>
        </group>
        <group group_id="E2">
          <title>Mepivacaine</title>
          <description>Subjects in this group will be given 70mg of Mepivacaine, which is within standard of care for spinal anesthesia during TKA or THA.&#xD;
Mepivacaine: 70 mg (3.5 mL of 2%) administered as an isobaric spinal anesthetic</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="80"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="80"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="74"/>
              </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. Matthew Abdel</name_or_title>
      <organization>Mayo Clinic</organization>
      <phone>507-538-1296</phone>
      <email>Abdel.Matthew@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/NCT03838874
org study id: 18-008635
nct id: NCT03838874
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This research is being done to see if there is a difference between two different spinal
      anesthetics (Mepivacaine vs. Bupivacaine) as it relates to reducing post-operative
      complications and the time it takes for subjects to regain mobility after surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Time to Return of Lower Extremity Motor Function
time frame: Post surgery, approximately 1 day
description: Assessed by measuring time from spinal anesthetic administration to postoperative achievement of Bromage 0 function (return of spontaneous ankle, knee, and hip movement) in the non-operative extremity at 15-minute intervals.
measure: Post-Anesthesia Care Unit (PACU) Length of Stay
time frame: Time of discharge, approximately 1-2 days
description: Number of minutes subjects were admitted to PACU following the surgical procedure
measure: Hospital Length of Stay
time frame: Time of discharge, approximately 1-2 days
description: Number days subjects were admitted to the hospital following the surgical procedure
measure: Maximum Pain Score
time frame: 24 hours following the surgical procedure
description: Measured on a scale from 1 to 10 in the first 24 hours following the surgical procedure, 1=mild pain; 10=worst pain.
measure: Median Pain Score
time frame: 24 hours following the surgical procedure
description: Measured on a scale from 1 to 10 in the first 24 hours following the surgical procedure, 1=mild pain; 10=worst pain.
measure: Discharge Pain Score
time frame: Time of discharge, approximately 1-2 days
description: Measured on a scale from 1 to 10 at time of hospital discharge, 1=mild pain; 10=worst pain.
measure: Orthostatic Hypotension
time frame: Time of discharge, approximately 1-2 days
description: Number of participants to experience orthostatic hypotension following the surgical procedure.
measure: Urinary Retention
time frame: Time of discharge, approximately 1-2 days
description: Number of participants to experience urinary retention follow the surgical procedure.
measure: Transient Neurologic Symptoms
time frame: One week post-operative
description: Number of participants to report transient neurologic symptoms
arm group label: Low-Dose Bupivacaine
arm group type: Active Comparator
description: Subjects in this group will be given 10mg of Low-Dose Bupivacaine, which is within standard of care for spinal anesthesia during TKA or THA.
arm group label: Mepivacaine
arm group type: Active Comparator
description: Subjects in this group will be given 70mg of Mepivacaine, which is within standard of care for spinal anesthesia during TKA or THA.
intervention type: Drug
intervention name: Low-Dose Bupivacaine
description: 10 mg (2 mL of 0.5%) administered as an isobaric spinal anesthetic
arm group label: Low-Dose Bupivacaine
intervention type: Drug
intervention name: Mepivacaine
description: 70 mg (3.5 mL of 2%) administered as an isobaric spinal anesthetic
arm group label: Mepivacaine
criteria: 
gender: All
minimum age: 18 Days
maximum age: N/A
healthy volunteers: No
last name: Matthew P Abdel, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Matthew P. Abdel, M.D.
investigator title: Principal Investigator
mesh term: Osteoarthritis
mesh term: Osteoarthritis, Hip
mesh term: Bupivacaine
mesh term: Mepivacaine
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 