<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/NCT02198235</url>
  </required_header>
  <id_info>
    <org_study_id>2012-017</org_study_id>
    <nct_id>NCT02198235</nct_id>
  </id_info>
  <brief_title>Prolonged Popliteal Fossa Nerve Blockade (Prolonged Pop)</brief_title>
  <official_title>Prolonged Popliteal Fossa Nerve Blockade</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>
      This study looks at addition of medications to the local anesthetic for the nerve blockade.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Following major foot and ankle surgery patients complain of severe pain. Currently, Hospital&#xD;
      for Special Surgery (HSS) usually uses nerve blocks (injections of local anesthetic near&#xD;
      nerves supplying the lower leg) to help manage pain after this type of surgery. Patients also&#xD;
      receive additional pain pills, including narcotics as needed. This study looks at addition of&#xD;
      medications to the local anesthetic for the nerve blockade. The investigators hope that these&#xD;
      medications (dexamethasone and buprenorphine) will prolong the pain relief from the nerve&#xD;
      block. There are 3 groups in the study. One group is a control, and receives usual therapy:&#xD;
      nerve block + pain pills. This is typically what the patient would receive as standard care&#xD;
      if they were not in the study. One group uses a nerve block with additives (+ pain pills).&#xD;
      One group gets a nerve block (local anesthetic only) + pain pills + intravenous buprenorphine&#xD;
      - this is meant to see if the buprenorphine acts directly on the nerve that was blocked, or&#xD;
      indirectly acts on the brain.&#xD;
&#xD;
      Patients will be followed while in the hospital, and contacted by telephone and/or email&#xD;
      after discharge for 2-3 days. Patients will be asked about their pain levels and the duration&#xD;
      of their block. The investigators will enroll 90 patients.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">January 2014</primary_completion_date>
  <phase>Phase 1</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>Other</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Numeric Rating Scale (NRS) Pain Score With Movement</measure>
    <time_frame>24 hours after the popliteal block is given</time_frame>
    <description>Pain with movement at 24 hours from the nerve block (0-10; 0 = no pain, 10 = worst possible pain)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Block Duration</measure>
    <time_frame>24 hours and 48 hours after the popliteal block is given</time_frame>
    <description>When did the nerve block entirely wear off?</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Numeric Rating Scale (NRS) Pain Score at Rest</measure>
    <time_frame>24 hours after the popliteal block is given</time_frame>
    <description>Pain at rest at 24 hours from the nerve block (0-10; 0 = no pain, 10 = worst possible pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median Time to Requiring Oral Opioids</measure>
    <time_frame>24 hours after the popliteal block is given</time_frame>
    <description>Did patient have pain requiring oral opioids?</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Postoperative Pain</condition>
  <arm_group>
    <arm_group_label>Control NB + IV Dex + IV Bup</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control NB + IV Dex</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>IV Dexamethasone (4 mg)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NB with Dex + Bup in block.</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dexamethasone (4 mg) Buprenorphine (150 mcg)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <arm_group_label>Control NB + IV Dex</arm_group_label>
    <arm_group_label>Control NB + IV Dex + IV Bup</arm_group_label>
    <arm_group_label>NB with Dex + Bup in block.</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Buprenorphine</intervention_name>
    <arm_group_label>Control NB + IV Dex + IV Bup</arm_group_label>
    <arm_group_label>NB with Dex + Bup in block.</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients of Dr. Levine or Dr. Roberts at Hospital for Special Surgery&#xD;
&#xD;
          -  Patients aged 18-75&#xD;
&#xD;
          -  Patients scheduled for discharge from HSS after foot or ankle surgery&#xD;
&#xD;
          -  A single-injection popliteal fossa nerve block is judged appropriate&#xD;
&#xD;
          -  Surgery confined to foot and ankle (no iliac crest bone graft planned - iliac aspirate&#xD;
             is not an exclusion criterion)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  &lt; 18 and &gt; 75&#xD;
&#xD;
          -  Surgery that will cause pain at sites outside the distal lower extremity (e.g. iliac&#xD;
             crest bone graft)&#xD;
&#xD;
          -  Bilateral surgery&#xD;
&#xD;
          -  Chronic pain (defined as regular use of opioid analgesics for &gt; 3 months)&#xD;
&#xD;
          -  Chronic use of steroids (defined as regular use of steroids for &gt; 3 months)&#xD;
&#xD;
          -  Contraindication to performance of the popliteal fossa nerve block with 30 cc 0.25%&#xD;
             bupivacaine (e.g. alleged bupivacaine sensitivity, low body weight, etc.)&#xD;
&#xD;
          -  Contraindications to dexamethasone or buprenorphine (e.g. allergy, insulin dependent&#xD;
             diabetes mellitus, etc.)&#xD;
&#xD;
          -  Patients who have been diagnosed with altered pain perception or have lack of&#xD;
             sensation&#xD;
&#xD;
          -  Inability of the patient to describe postoperative pain (e.g. psychiatric disorder,&#xD;
             dementia)&#xD;
&#xD;
          -  Non-English speaking patients (the questionnaire is in English, and translations would&#xD;
             have to be separately validated)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jacques YaDeau, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital for Special Surgery, New York</affiliation>
  </overall_official>
  <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>May 2017</verification_date>
  <study_first_submitted>September 21, 2012</study_first_submitted>
  <study_first_submitted_qc>July 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 23, 2014</study_first_posted>
  <results_first_submitted>July 21, 2015</results_first_submitted>
  <results_first_submitted_qc>January 29, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 29, 2016</results_first_posted>
  <last_update_submitted>May 22, 2017</last_update_submitted>
  <last_update_submitted_qc>May 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Buprenorphine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Control Nerve Block + IV Dexamethasone</title>
          <description>IV Dexamethasone (4 mg)&#xD;
Dexamethasone</description>
        </group>
        <group group_id="P2">
          <title>Control Nerve Block + IV Dexamethasone + IV Buprenorphine</title>
          <description>IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)&#xD;
Dexamethasone&#xD;
Buprenorphine</description>
        </group>
        <group group_id="P3">
          <title>Nerve Block With Dexamethasone + Buprenorphine in Block.</title>
          <description>Dexamethasone (4 mg) Buprenorphine (150 mcg)&#xD;
Dexamethasone&#xD;
Buprenorphine</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="30"/>
                <participants group_id="P3" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="27"/>
                <participants group_id="P2" count="28"/>
                <participants group_id="P3" count="28"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="2"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Control Nerve Block + IV Dexamethasone</title>
          <description>IV Dexamethasone (4 mg)&#xD;
Dexamethasone</description>
        </group>
        <group group_id="B2">
          <title>Control Nerve Block + IV Dexamethasone + IV Buprenorphine</title>
          <description>IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)&#xD;
Dexamethasone&#xD;
Buprenorphine</description>
        </group>
        <group group_id="B3">
          <title>Nerve Block With Dexamethasone + Buprenorphine in Block.</title>
          <description>Dexamethasone (4 mg) Buprenorphine (150 mcg)&#xD;
Dexamethasone&#xD;
Buprenorphine</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="30"/>
            <count group_id="B2" value="30"/>
            <count group_id="B3" value="30"/>
            <count group_id="B4" value="90"/>
          </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="51.2" spread="15.9"/>
                    <measurement group_id="B2" value="51.1" spread="15.3"/>
                    <measurement group_id="B3" value="52.8" spread="14.2"/>
                    <measurement group_id="B4" value="51.7" spread="15"/>
                  </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="16"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="17"/>
                    <measurement group_id="B4" value="51"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="13"/>
                    <measurement group_id="B4" value="39"/>
                  </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>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="30"/>
                    <measurement group_id="B4" value="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI (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="27.2" spread="5.68"/>
                    <measurement group_id="B2" value="26.3" spread="4.37"/>
                    <measurement group_id="B3" value="26.3" spread="5.16"/>
                    <measurement group_id="B4" value="26.6" spread="5.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Numeric Rating Scale (NRS) Pain Score With Movement</title>
        <description>Pain with movement at 24 hours from the nerve block (0-10; 0 = no pain, 10 = worst possible pain)</description>
        <time_frame>24 hours after the popliteal block is given</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control Nerve Block + IV Dexamethasone</title>
            <description>IV Dexamethasone (4 mg)&#xD;
Dexamethasone</description>
          </group>
          <group group_id="O2">
            <title>Control Nerve Block + IV Dexamethasone + IV Buprenorphine</title>
            <description>IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)&#xD;
Dexamethasone&#xD;
Buprenorphine</description>
          </group>
          <group group_id="O3">
            <title>Nerve Block With Dexamethasone + Buprenorphine in Block.</title>
            <description>Dexamethasone (4 mg) Buprenorphine (150 mcg)&#xD;
Dexamethasone&#xD;
Buprenorphine</description>
          </group>
        </group_list>
        <measure>
          <title>Numeric Rating Scale (NRS) Pain Score With Movement</title>
          <description>Pain with movement at 24 hours from the nerve block (0-10; 0 = no pain, 10 = worst possible pain)</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" spread="2.6"/>
                    <measurement group_id="O2" value="1" spread="1.6"/>
                    <measurement group_id="O3" value="1.3" spread="2.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Block Duration</title>
        <description>When did the nerve block entirely wear off?</description>
        <time_frame>24 hours and 48 hours after the popliteal block is given</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control Nerve Block + IV Dexamethasone</title>
            <description>IV Dexamethasone (4 mg)&#xD;
Dexamethasone</description>
          </group>
          <group group_id="O2">
            <title>Control Nerve Block + IV Dexamethasone + IV Buprenorphine</title>
            <description>IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)&#xD;
Dexamethasone&#xD;
Buprenorphine</description>
          </group>
          <group group_id="O3">
            <title>Nerve Block With Dexamethasone + Buprenorphine in Block.</title>
            <description>Dexamethasone (4 mg) Buprenorphine (150 mcg)&#xD;
Dexamethasone&#xD;
Buprenorphine</description>
          </group>
        </group_list>
        <measure>
          <title>Block Duration</title>
          <description>When did the nerve block entirely wear off?</description>
          <units>hours</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="30" lower_limit="24.1" upper_limit="45.2"/>
                    <measurement group_id="O2" value="37.9" lower_limit="30.7" upper_limit="43.9"/>
                    <measurement group_id="O3" value="45.6" lower_limit="33.9" upper_limit="53.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Numeric Rating Scale (NRS) Pain Score at Rest</title>
        <description>Pain at rest at 24 hours from the nerve block (0-10; 0 = no pain, 10 = worst possible pain)</description>
        <time_frame>24 hours after the popliteal block is given</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control Nerve Block + IV Dexamethasone</title>
            <description>IV Dexamethasone (4 mg)&#xD;
Dexamethasone</description>
          </group>
          <group group_id="O2">
            <title>Control Nerve Block + IV Dexamethasone + IV Buprenorphine</title>
            <description>IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)&#xD;
Dexamethasone&#xD;
Buprenorphine</description>
          </group>
          <group group_id="O3">
            <title>Nerve Block With Dexamethasone + Buprenorphine in Block.</title>
            <description>Dexamethasone (4 mg) Buprenorphine (150 mcg)&#xD;
Dexamethasone&#xD;
Buprenorphine</description>
          </group>
        </group_list>
        <measure>
          <title>Numeric Rating Scale (NRS) Pain Score at Rest</title>
          <description>Pain at rest at 24 hours from the nerve block (0-10; 0 = no pain, 10 = worst possible pain)</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Error</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.8" spread="2.5"/>
                    <measurement group_id="O2" value=".9" spread="1.3"/>
                    <measurement group_id="O3" value=".8" spread="1.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median Time to Requiring Oral Opioids</title>
        <description>Did patient have pain requiring oral opioids?</description>
        <time_frame>24 hours after the popliteal block is given</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control Nerve Block + IV Dexamethasone</title>
            <description>IV Dexamethasone (4 mg)&#xD;
Dexamethasone</description>
          </group>
          <group group_id="O2">
            <title>Control Nerve Block + IV Dexamethasone + IV Buprenorphine</title>
            <description>IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)&#xD;
Dexamethasone&#xD;
Buprenorphine</description>
          </group>
          <group group_id="O3">
            <title>Nerve Block With Dexamethasone + Buprenorphine in Block.</title>
            <description>Dexamethasone (4 mg) Buprenorphine (150 mcg)&#xD;
Dexamethasone&#xD;
Buprenorphine</description>
          </group>
        </group_list>
        <measure>
          <title>Median Time to Requiring Oral Opioids</title>
          <description>Did patient have pain requiring oral opioids?</description>
          <units>hours</units>
          <param>Median</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="27"/>
                <count group_id="O2" value="28"/>
                <count group_id="O3" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="25.5" lower_limit="18.0" upper_limit="34.7"/>
                    <measurement group_id="O2" value="30" lower_limit="26.8" upper_limit="40.5"/>
                    <measurement group_id="O3" value="35.3" lower_limit="30.3" upper_limit="55.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Control Nerve Block + IV Dexamethasone</title>
          <description>IV Dexamethasone (4 mg)&#xD;
Dexamethasone</description>
        </group>
        <group group_id="E2">
          <title>Control Nerve Block + IV Dexamethasone + IV Buprenorphine</title>
          <description>IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)&#xD;
Dexamethasone&#xD;
Buprenorphine</description>
        </group>
        <group group_id="E3">
          <title>Nerve Block With Dexamethasone + Buprenorphine in Block.</title>
          <description>Dexamethasone (4 mg) Buprenorphine (150 mcg)&#xD;
Dexamethasone&#xD;
Buprenorphine</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="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
              </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="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="30"/>
              </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. Jacques YaDeau</name_or_title>
      <organization>Hospital for Special Surgery</organization>
      <phone>212-606-1206</phone>
      <email>yadeauj@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/NCT02198235
org study id: 2012-017
nct id: NCT02198235
lead sponsor: 
has dmc: No
This study looks at addition of medications to the local anesthetic for the nerve blockade.
Following major foot and ankle surgery patients complain of severe pain. Currently, Hospital
      for Special Surgery (HSS) usually uses nerve blocks (injections of local anesthetic near
      nerves supplying the lower leg) to help manage pain after this type of surgery. Patients also
      receive additional pain pills, including narcotics as needed. This study looks at addition of
      medications to the local anesthetic for the nerve blockade. The investigators hope that these
      medications (dexamethasone and buprenorphine) will prolong the pain relief from the nerve
      block. There are 3 groups in the study. One group is a control, and receives usual therapy:
      nerve block + pain pills. This is typically what the patient would receive as standard care
      if they were not in the study. One group uses a nerve block with additives (+ pain pills).
      One group gets a nerve block (local anesthetic only) + pain pills + intravenous buprenorphine
      - this is meant to see if the buprenorphine acts directly on the nerve that was blocked, or
      indirectly acts on the brain.

      Patients will be followed while in the hospital, and contacted by telephone and/or email
      after discharge for 2-3 days. Patients will be asked about their pain levels and the duration
      of their block. The investigators will enroll 90 patients.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Participant, Outcomes Assessor)
measure: Numeric Rating Scale (NRS) Pain Score With Movement
time frame: 24 hours after the popliteal block is given
description: Pain with movement at 24 hours from the nerve block (0-10; 0 = no pain, 10 = worst possible pain)
measure: Block Duration
time frame: 24 hours and 48 hours after the popliteal block is given
description: When did the nerve block entirely wear off?
measure: Numeric Rating Scale (NRS) Pain Score at Rest
time frame: 24 hours after the popliteal block is given
description: Pain at rest at 24 hours from the nerve block (0-10; 0 = no pain, 10 = worst possible pain)
measure: Median Time to Requiring Oral Opioids
time frame: 24 hours after the popliteal block is given
description: Did patient have pain requiring oral opioids?
arm group label: Control NB + IV Dex + IV Bup
arm group type: Active Comparator
description: IV Dexamethasone (4 mg) + IV Buprenorphine (150 mcg)
arm group label: Control NB + IV Dex
arm group type: Active Comparator
description: IV Dexamethasone (4 mg)
arm group label: NB with Dex + Bup in block.
arm group type: Experimental
description: Dexamethasone (4 mg) Buprenorphine (150 mcg)
intervention type: Drug
intervention name: Dexamethasone
arm group label: Control NB + IV Dex
arm group label: Control NB + IV Dex + IV Bup
arm group label: NB with Dex + Bup in block.
intervention type: Drug
intervention name: Buprenorphine
arm group label: Control NB + IV Dex + IV Bup
arm group label: NB with Dex + Bup in block.
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Jacques YaDeau, MD, PhD
role: Principal Investigator
affiliation: Hospital for Special Surgery, New York
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Dexamethasone
mesh term: Buprenorphine
sharing ipd: No
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 