<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/NCT01701102</url>
  </required_header>
  <id_info>
    <org_study_id>11140</org_study_id>
    <nct_id>NCT01701102</nct_id>
  </id_info>
  <brief_title>Study to Find Optimal Dose of Local Spinal Anesthetic (Mepivacaine) Combined With Narcotic (Fentanyl) For Knee Surgery</brief_title>
  <official_title>Optimal Dose of Spinal Mepivacaine Combined With Fentanyl For Knee Arthroscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital for Special Surgery, New York</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital for Special Surgery, New York</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prolonged motor block and delayed ability to walk are limitations of spinal anesthesia in&#xD;
      ambulatory (same-day) surgery. This can be improved by lowering the dose of local anesthetic&#xD;
      (a medication that, when injected around nerves, blocks nerve conduction, resulting in&#xD;
      numbness and weakness) used in the spine, but too low a dose can result in an incomplete&#xD;
      block (inadequate anesthesia) in some patients. There is evidence that adding a low dose of&#xD;
      fentanyl, a narcotic, to mepivacaine enhances the anesthetic effect. The purpose of this&#xD;
      study is to determine the lowest dose of mepivacaine, a local anesthetic, when combined with&#xD;
      fentanyl, for which spinal anesthesia is adequate for ambulatory knee arthroscopy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2011</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">July 2012</primary_completion_date>
  <phase>N/A</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, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time From Spinal Administration to Block Regression to the S1 Dermatome in Post-Anesthesia Care Unit (PACU)</measure>
    <time_frame>Participants will be followed for the duration of their recovery after surgery in the post-anesthesia care unit (PACU), an expected average of 2-4 hours.</time_frame>
    <description>The time frame of the study for each patient only covers the period between time of surgery and time of discharge from the hospital, which is on the same day as the day of surgery</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">56</enrollment>
  <condition>Arthroscopic Knee Surgery</condition>
  <arm_group>
    <arm_group_label>Mepivacaine 37.5 mg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Mepivacaine 30 mg plus fentanyl 10 µg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Mepivacaine 27 mg plus fentanyl 10 µg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Mepivacaine 24 mg plus fentanyl 10 µg</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Mepivacaine (24 mg) plus fentanyl</intervention_name>
    <description>Mepivacaine (24 mg) and fentanyl (10 µg)</description>
    <arm_group_label>Mepivacaine 24 mg plus fentanyl 10 µg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Mepivacaine (27 mg) plus fentanyl</intervention_name>
    <description>Mepivacaine (27 mg) and fentanyl (10 µg)</description>
    <arm_group_label>Mepivacaine 27 mg plus fentanyl 10 µg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Mepivacaine (30 mg) plus fentanyl</intervention_name>
    <description>Mepivacaine (30 mg) and fentanyl (10 µg)</description>
    <arm_group_label>Mepivacaine 30 mg plus fentanyl 10 µg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Mepivacaine</intervention_name>
    <description>Mepivacaine 37.5 mg</description>
    <arm_group_label>Mepivacaine 37.5 mg</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects aged 18-60&#xD;
&#xD;
          -  Patients scheduled for &quot;simple&quot; knee arthroscopies, including meniscectomy,&#xD;
             debridement, and plica.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects aged &lt;18 or &gt;60&#xD;
&#xD;
          -  Subjects greater than 190 cm in height&#xD;
&#xD;
          -  Patients scheduled for ligament reconstruction or surgery involving bone&#xD;
&#xD;
          -  Daily use of narcotics for greater than one week pre-op&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Hospital for Special Surgery</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>January 4, 2012</study_first_submitted>
  <study_first_submitted_qc>October 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <results_first_submitted>February 11, 2016</results_first_submitted>
  <results_first_submitted_qc>February 11, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">March 10, 2016</results_first_posted>
  <last_update_submitted>March 9, 2016</last_update_submitted>
  <last_update_submitted_qc>March 9, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 5, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fentanyl</mesh_term>
    <mesh_term>Mepivacaine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Mepivacaine 37.5 mg</title>
          <description>Mepivacaine (37.5 mg)</description>
        </group>
        <group group_id="P2">
          <title>Mepivacaine 30 mg Plus Fentanyl 10 µg</title>
          <description>Mepivacaine plus fentanyl: Mepivacaine (30 mg) and fentanyl (10 µg)</description>
        </group>
        <group group_id="P3">
          <title>Mepivacaine 27 mg Plus Fentanyl 10 µg</title>
          <description>Mepivacaine plus fentanyl: Mepivacaine (27 mg) and fentanyl (10 µg)</description>
        </group>
        <group group_id="P4">
          <title>Mepivacaine 24 mg Plus Fentanyl 10 µg</title>
          <description>Mepivacaine plus fentanyl: Mepivacaine (24 mg) and fentanyl (10 µg)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="10"/>
                <participants group_id="P4" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="22"/>
                <participants group_id="P2" count="6"/>
                <participants group_id="P3" count="10"/>
                <participants group_id="P4" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="0"/>
                <participants group_id="P4" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Mepivacaine 37.5 mg</title>
          <description>Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)</description>
        </group>
        <group group_id="B2">
          <title>Mepivacaine 30 mg Plus Fentanyl 10 µg</title>
          <description>Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)</description>
        </group>
        <group group_id="B3">
          <title>Mepivacaine 27 mg Plus Fentanyl 10 µg</title>
          <description>Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)</description>
        </group>
        <group group_id="B4">
          <title>Mepivacaine 24 mg Plus Fentanyl 10 µg</title>
          <description>Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)</description>
        </group>
        <group group_id="B5">
          <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="22"/>
            <count group_id="B2" value="6"/>
            <count group_id="B3" value="10"/>
            <count group_id="B4" value="18"/>
            <count group_id="B5" value="56"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41" lower_limit="19" upper_limit="55"/>
                    <measurement group_id="B2" value="50" lower_limit="42" upper_limit="57"/>
                    <measurement group_id="B3" value="46" lower_limit="27" upper_limit="60"/>
                    <measurement group_id="B4" value="45" lower_limit="19" upper_limit="60"/>
                    <measurement group_id="B5" value="44" lower_limit="19" upper_limit="60"/>
                  </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="12"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="5"/>
                    <measurement group_id="B5" value="22"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="8"/>
                    <measurement group_id="B4" value="13"/>
                    <measurement group_id="B5" value="34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index</title>
          <units>kg/(m^2)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.3" spread="3.8"/>
                    <measurement group_id="B2" value="26.0" spread="4.3"/>
                    <measurement group_id="B3" value="28.5" spread="5.6"/>
                    <measurement group_id="B4" value="28.7" spread="4.8"/>
                    <measurement group_id="B5" value="27.4" spread="4.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Time From Spinal Administration to Block Regression to the S1 Dermatome in Post-Anesthesia Care Unit (PACU)</title>
        <description>The time frame of the study for each patient only covers the period between time of surgery and time of discharge from the hospital, which is on the same day as the day of surgery</description>
        <time_frame>Participants will be followed for the duration of their recovery after surgery in the post-anesthesia care unit (PACU), an expected average of 2-4 hours.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mepivacaine 37.5 mg</title>
            <description>Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)</description>
          </group>
          <group group_id="O2">
            <title>Mepivacaine 30 mg Plus Fentanyl 10 µg</title>
            <description>Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)</description>
          </group>
          <group group_id="O3">
            <title>Mepivacaine 27 mg Plus Fentanyl 10 µg</title>
            <description>Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)</description>
          </group>
          <group group_id="O4">
            <title>Mepivacaine 24 mg Plus Fentanyl 10 µg</title>
            <description>Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)</description>
          </group>
        </group_list>
        <measure>
          <title>Time From Spinal Administration to Block Regression to the S1 Dermatome in Post-Anesthesia Care Unit (PACU)</title>
          <description>The time frame of the study for each patient only covers the period between time of surgery and time of discharge from the hospital, which is on the same day as the day of surgery</description>
          <units>minutes</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="22"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="10"/>
                <count group_id="O4" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="203" lower_limit="165" upper_limit="231"/>
                    <measurement group_id="O2" value="195" lower_limit="175" upper_limit="210"/>
                    <measurement group_id="O3" value="156" lower_limit="135" upper_limit="180"/>
                    <measurement group_id="O4" value="159" lower_limit="135" upper_limit="194"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Mepivacaine 37.5 mg</title>
          <description>Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)</description>
        </group>
        <group group_id="E2">
          <title>Mepivacaine 30 mg Plus Fentanyl 10 µg</title>
          <description>Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)</description>
        </group>
        <group group_id="E3">
          <title>Mepivacaine 27 mg Plus Fentanyl 10 µg</title>
          <description>Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)</description>
        </group>
        <group group_id="E4">
          <title>Mepivacaine 24 mg Plus Fentanyl 10 µg</title>
          <description>Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
              </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="22"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="6"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="10"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="18"/>
              </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>Jennifer Cheng</name_or_title>
      <organization>Hospital for Special Surgery</organization>
      <phone>212-774-7377</phone>
      <email>chengj@hss.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/NCT01701102
org study id: 11140
nct id: NCT01701102
lead sponsor: 
has dmc: No
Prolonged motor block and delayed ability to walk are limitations of spinal anesthesia in
      ambulatory (same-day) surgery. This can be improved by lowering the dose of local anesthetic
      (a medication that, when injected around nerves, blocks nerve conduction, resulting in
      numbness and weakness) used in the spine, but too low a dose can result in an incomplete
      block (inadequate anesthesia) in some patients. There is evidence that adding a low dose of
      fentanyl, a narcotic, to mepivacaine enhances the anesthetic effect. The purpose of this
      study is to determine the lowest dose of mepivacaine, a local anesthetic, when combined with
      fentanyl, for which spinal anesthesia is adequate for ambulatory knee arthroscopy.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Time From Spinal Administration to Block Regression to the S1 Dermatome in Post-Anesthesia Care Unit (PACU)
time frame: Participants will be followed for the duration of their recovery after surgery in the post-anesthesia care unit (PACU), an expected average of 2-4 hours.
description: The time frame of the study for each patient only covers the period between time of surgery and time of discharge from the hospital, which is on the same day as the day of surgery
arm group label: Mepivacaine 37.5 mg
arm group type: Active Comparator
arm group label: Mepivacaine 30 mg plus fentanyl 10 µg
arm group type: Active Comparator
arm group label: Mepivacaine 27 mg plus fentanyl 10 µg
arm group type: Active Comparator
arm group label: Mepivacaine 24 mg plus fentanyl 10 µg
arm group type: Active Comparator
intervention type: Procedure
intervention name: Mepivacaine (24 mg) plus fentanyl
description: Mepivacaine (24 mg) and fentanyl (10 µg)
arm group label: Mepivacaine 24 mg plus fentanyl 10 µg
intervention type: Procedure
intervention name: Mepivacaine (27 mg) plus fentanyl
description: Mepivacaine (27 mg) and fentanyl (10 µg)
arm group label: Mepivacaine 27 mg plus fentanyl 10 µg
intervention type: Procedure
intervention name: Mepivacaine (30 mg) plus fentanyl
description: Mepivacaine (30 mg) and fentanyl (10 µg)
arm group label: Mepivacaine 30 mg plus fentanyl 10 µg
intervention type: Procedure
intervention name: Mepivacaine
description: Mepivacaine 37.5 mg
arm group label: Mepivacaine 37.5 mg
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Fentanyl
mesh term: Mepivacaine
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 