<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/NCT02980926</url>
  </required_header>
  <id_info>
    <org_study_id>#10455</org_study_id>
    <nct_id>NCT02980926</nct_id>
  </id_info>
  <brief_title>Mepivacaine vs. Bupivacaine Spinal Anesthetic in Total Knee Arthroplasty</brief_title>
  <official_title>Mepivacaine vs. Bupivacaine Spinal Anesthetic in Total Knee Arthroplasty, a Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Henry Ford Health System</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Henry Ford Health System</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if a shorter-acting spinal anesthetic called&#xD;
      mepivacaine has advantages over a longer-acting medication called bupivacaine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Different medications last for different amounts of time and can be changed depending on the&#xD;
      length of the procedure. A short acting spinal is generally used for procedures lasting less&#xD;
      than 90 minutes. A longer acting medication would be any that lasts longer than 90 minutes.&#xD;
      These medications not only block the signals that travel along the pain nerves, they also&#xD;
      prevent the signals that tell the patients muscles to move. This means that after a total&#xD;
      knee replacement a patient may delayed in their ability to get up and start walking early&#xD;
      after surgery. Walking early in the recovery has been shown to decrease the rate of pulmonary&#xD;
      embolism and death. Ambulating early is also important to prevent loss of strength,&#xD;
      constipation, pneumonia and urinary retention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">March 2017</completion_date>
  <primary_completion_date type="Actual">March 2017</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Return of motor and sensory function</measure>
    <time_frame>Exams will take place in 15 minute intervals beginning with arrival to the PACU and will be continued for a maximum of 6 hours or until the exam returns to baseline for 2 consecutive exams.</time_frame>
    <description>Times will be recorded in minutes from the administration of the spinal anesthetic. Normal exam will include intact sensation to light touch of the thigh, calf, foot and toes. Normal motor is defined as ability to perform a straight leg raise, active knee flexion, as well as wiggling of the ankle and toes.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain</measure>
    <time_frame>Entire hospital admission. No data will be recorded after 96 hours.</time_frame>
    <description>visual analog scale from 0 - 10</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain</measure>
    <time_frame>Hospital admission, maximum of 96 hours.</time_frame>
    <description>morphine equivalent consumption</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to urination</measure>
    <time_frame>24 hours maximum from time of spinal.</time_frame>
    <description>The total time between the administration of spinal anesthesia to the first episode of spontaneous urination will be recorded. Patients who require greater than 6 hours to urinate independently are followed per hospital protocol with serial bladder scans and straight catheterization for urinary retention as needed. Patients who exceed 6 hours to urinate will be defined as having urinary retention.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary retention</measure>
    <time_frame>Entire hospital stay beginning immediately in the post operative period until discharge to a maximum of 96 hours.</time_frame>
    <description>The number of straight catheterization and foley placements will be recorded as well.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of stay</measure>
    <time_frame>Hospital admission maximum of 96 hours.</time_frame>
    <description>Length of stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to discharge readiness.</measure>
    <time_frame>Hospital admission maximum of 96 hours.</time_frame>
    <description>Time from admission to discharge readiness as assessed by physical therapy.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Transient Neurologic Symptoms</measure>
    <time_frame>Hospital admission and first follow up visit. Data will not be recorded after 3 weeks from time of spinal</time_frame>
    <description>Any episodes of transient radiating pain in the buttocks and thigh will be recorded in the hospital charts during routine post operative rounds. This is also be discussed at the first follow up visit scheduled 2 weeks after surgery.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Anesthesia, Spinal</condition>
  <condition>Arthroplasty, Replacement, Knee</condition>
  <condition>Pain Management</condition>
  <condition>Early Ambulation</condition>
  <condition>Ambulatory Surgical Procedures</condition>
  <arm_group>
    <arm_group_label>Mepivacaine Spinal Anesthetic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Mepivacaine 3 mL intrathecal injection of 2% solution</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bupivacaine Spinal Anesthetic</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bupivacaine 12 mg of 8.25% solution</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mepivacaine</intervention_name>
    <description>This is a shorter acting spinal anesthetic as compared to the current standard of care at this institution.</description>
    <arm_group_label>Mepivacaine Spinal Anesthetic</arm_group_label>
    <other_name>CAS Number: 96-88-8</other_name>
    <other_name>Carbocaine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
    <description>This is the current standard of care at this institution and many centers. This is a longer acting spinal anesthetic compared to the study drug.</description>
    <arm_group_label>Bupivacaine Spinal Anesthetic</arm_group_label>
    <other_name>Sensorcaine</other_name>
    <other_name>Marcaine</other_name>
    <other_name>CAS 38396-39-3</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients undergoing primary total knee arthroplasty&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic opioid users&#xD;
&#xD;
          -  Unable to give informed consent&#xD;
&#xD;
          -  Forego the use of a foley catheter&#xD;
&#xD;
          -  Those with hypersensitively to amide local anesthetics or opioids&#xD;
&#xD;
          -  Those with contraindications to spinal anesthesia&#xD;
&#xD;
          -  Conversion to general anesthesia will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jason Davis, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Surgeon</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Henry Ford West Bloomfield</name>
      <address>
        <city>West Bloomfield Township</city>
        <state>Michigan</state>
        <zip>48322</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>September 21, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>March 23, 2017</last_update_submitted>
  <last_update_submitted_qc>March 23, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Henry Ford Health System</investigator_affiliation>
    <investigator_full_name>M. Chad Mahan, M.D.</investigator_full_name>
    <investigator_title>PGY-3</investigator_title>
  </responsible_party>
  <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>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02980926
org study id: #10455
nct id: NCT02980926
lead sponsor: 
has dmc: No
The purpose of this study is to determine if a shorter-acting spinal anesthetic called
      mepivacaine has advantages over a longer-acting medication called bupivacaine.
Different medications last for different amounts of time and can be changed depending on the
      length of the procedure. A short acting spinal is generally used for procedures lasting less
      than 90 minutes. A longer acting medication would be any that lasts longer than 90 minutes.
      These medications not only block the signals that travel along the pain nerves, they also
      prevent the signals that tell the patients muscles to move. This means that after a total
      knee replacement a patient may delayed in their ability to get up and start walking early
      after surgery. Walking early in the recovery has been shown to decrease the rate of pulmonary
      embolism and death. Ambulating early is also important to prevent loss of strength,
      constipation, pneumonia and urinary retention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Return of motor and sensory function
time frame: Exams will take place in 15 minute intervals beginning with arrival to the PACU and will be continued for a maximum of 6 hours or until the exam returns to baseline for 2 consecutive exams.
description: Times will be recorded in minutes from the administration of the spinal anesthetic. Normal exam will include intact sensation to light touch of the thigh, calf, foot and toes. Normal motor is defined as ability to perform a straight leg raise, active knee flexion, as well as wiggling of the ankle and toes.
measure: Pain
time frame: Entire hospital admission. No data will be recorded after 96 hours.
description: visual analog scale from 0 - 10
measure: Pain
time frame: Hospital admission, maximum of 96 hours.
description: morphine equivalent consumption
measure: Time to urination
time frame: 24 hours maximum from time of spinal.
description: The total time between the administration of spinal anesthesia to the first episode of spontaneous urination will be recorded. Patients who require greater than 6 hours to urinate independently are followed per hospital protocol with serial bladder scans and straight catheterization for urinary retention as needed. Patients who exceed 6 hours to urinate will be defined as having urinary retention.
measure: Urinary retention
time frame: Entire hospital stay beginning immediately in the post operative period until discharge to a maximum of 96 hours.
description: The number of straight catheterization and foley placements will be recorded as well.
measure: Length of stay
time frame: Hospital admission maximum of 96 hours.
description: Length of stay
measure: Time to discharge readiness.
time frame: Hospital admission maximum of 96 hours.
description: Time from admission to discharge readiness as assessed by physical therapy.
measure: Transient Neurologic Symptoms
time frame: Hospital admission and first follow up visit. Data will not be recorded after 3 weeks from time of spinal
description: Any episodes of transient radiating pain in the buttocks and thigh will be recorded in the hospital charts during routine post operative rounds. This is also be discussed at the first follow up visit scheduled 2 weeks after surgery.
arm group label: Mepivacaine Spinal Anesthetic
arm group type: Experimental
description: Mepivacaine 3 mL intrathecal injection of 2% solution
arm group label: Bupivacaine Spinal Anesthetic
arm group type: Active Comparator
description: Bupivacaine 12 mg of 8.25% solution
intervention type: Drug
intervention name: Mepivacaine
description: This is a shorter acting spinal anesthetic as compared to the current standard of care at this institution.
arm group label: Mepivacaine Spinal Anesthetic
other name: CAS Number: 96-88-8
other name: Carbocaine
intervention type: Drug
intervention name: Bupivacaine
description: This is the current standard of care at this institution and many centers. This is a longer acting spinal anesthetic compared to the study drug.
arm group label: Bupivacaine Spinal Anesthetic
other name: Sensorcaine
other name: Marcaine
other name: CAS 38396-39-3
criteria: 
gender: All
minimum age: 40 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jason Davis, MD
role: Principal Investigator
affiliation: Surgeon
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Henry Ford Health System
investigator full name: M. Chad Mahan, M.D.
investigator title: PGY-3
mesh term: Bupivacaine
mesh term: Mepivacaine
sharing ipd: No