<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/NCT01690663</url>
  </required_header>
  <id_info>
    <org_study_id>815628</org_study_id>
    <nct_id>NCT01690663</nct_id>
  </id_info>
  <brief_title>Dose Response Study of Dexamethasone in Combination With Bupivacaine 0.25%</brief_title>
  <acronym>Dex Dose</acronym>
  <official_title>Dose Response Study of Dexamethasone in Combination With Bupivacaine 0.25% in Ultrasound Guided Supraclavicular Brachial Plexus Nerve Block, a Randomized, Placebo Controlled Prospective Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pennsylvania</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Pennsylvania</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      When used in conjunction with a local anesthetic, dexamethasone may prolong both the sensory&#xD;
      and motor effects of high supraclavicular brachial plexus nerve block (SBP) in arthroscopic&#xD;
      shoulder surgery. This study seeks to determine if there is a relationship between the&#xD;
      duration of sensory and motor blockade in supraclavicular brachial plexus nerve blocks (SBP)&#xD;
      when combined with increasing doses of dexamethasone.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The exact mechanism of dexamethasone on peripheral nerve block is unclear. The current theory&#xD;
      is that the effect is not dose related, while only 4mg and 8mg doses were studied. Our&#xD;
      hypothesis is that the dose differences at 1mg, 2mg, or 4mg, does not have significant effect&#xD;
      on the duration of analgesia. Therefore, we are not considering any patients to receive&#xD;
      suboptimal dosing of preservative free dexamethasone in this study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">February 2015</completion_date>
  <primary_completion_date type="Actual">February 2015</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>Primary Outcome Variable is Post Operative Sensory Block Duration</measure>
    <time_frame>days 1, 2, and day 7</time_frame>
    <description>This is defined as time from the completion of the block to the initiation of supplemental analgesia medications after hospital discharge. The patients were evaluated on different days to capture the exact end time, which was the initiation of supplemental analgesia medication. We intentionally contacted patients several times to capture the time as early as possible to minimize recall bias.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The Secondary Outcome Variable is Post Operative Motor Block Duration</measure>
    <time_frame>days 1, 2, and day 7</time_frame>
    <description>This is defined as time from the completion of the block to the time when patient is able to move his or her forearm and/or hands. The patients were evaluated on different days to capture the exact end time, which was the initiation of supplemental analgesia medication. We intentionally contacted patients several times to capture the time as early as possible to minimize recall bias.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">89</enrollment>
  <condition>Post Surgical Pain</condition>
  <arm_group>
    <arm_group_label>Bupivacaine 0.25% mixed with 1ml normal saline</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bupivacaine 0.25% with 1mg dexamethasone (1ml)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bupivacaine 0.25% mixed with 2mg dexamethasone</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bupivacaine 0.25% mixed with 4mg dexamethasone (1ml</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine 0.25%</intervention_name>
    <arm_group_label>Bupivacaine 0.25% mixed with 1ml normal saline</arm_group_label>
    <arm_group_label>Bupivacaine 0.25% mixed with 2mg dexamethasone</arm_group_label>
    <arm_group_label>Bupivacaine 0.25% mixed with 4mg dexamethasone (1ml</arm_group_label>
    <arm_group_label>Bupivacaine 0.25% with 1mg dexamethasone (1ml)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <arm_group_label>Bupivacaine 0.25% mixed with 2mg dexamethasone</arm_group_label>
    <arm_group_label>Bupivacaine 0.25% mixed with 4mg dexamethasone (1ml</arm_group_label>
    <arm_group_label>Bupivacaine 0.25% with 1mg dexamethasone (1ml)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>normal saline</intervention_name>
    <description>placebo</description>
    <arm_group_label>Bupivacaine 0.25% mixed with 1ml normal saline</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients aged 18 to 70 scheduled for primary shoulder arthroscopy who have already&#xD;
             elected to receive and are eligible for regional anesthesia (brachial plexus nerve&#xD;
             block) prior to consenting for study.&#xD;
&#xD;
          2. Ability to sign informed consent.&#xD;
&#xD;
          3. Ability to follow study protocol, and speak, read and write in English.&#xD;
&#xD;
          4. Must have valid phone number for follow-up purpose.&#xD;
&#xD;
          5. Must be able to receive all protocol medications to include the dexamethasone,&#xD;
             ketorolac, hydromorphone, and percocet.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient younger than 18 years old and older than age 70&#xD;
&#xD;
          2. Patient refusal to sign consent&#xD;
&#xD;
          3. Chronic opioid use (defined as narcotic use longer than 3 months) as documented in&#xD;
             patient's medical record&#xD;
&#xD;
          4. Allergy to any of the protocol medications&#xD;
&#xD;
          5. Patients with severe lung disease, contra lateral phrenic nerve injury,&#xD;
             insulin-dependent diabetes, hepatic disease/failure, kidney disease/failure as&#xD;
             documented in patient's medical record&#xD;
&#xD;
          6. Pregnancy (positive urine pregnancy test result in Preop area on morning of surgery)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jiabin Liu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Pennsylvania</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Penn Presbyterian Medical Center</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19139</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 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 18, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <results_first_submitted>October 21, 2016</results_first_submitted>
  <results_first_submitted_qc>March 23, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">May 4, 2017</results_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">May 4, 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>Bupivacaine</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Bupivacaine 0.25% Mixed With 1ml Normal Saline</title>
          <description>Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group)&#xD;
Bupivacaine 0.25%&#xD;
normal saline: placebo</description>
        </group>
        <group group_id="P2">
          <title>Bupivacaine 0.25% With 1mg Dexamethasone (1ml)</title>
          <description>Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml)&#xD;
Bupivacaine 0.25%&#xD;
Dexamethasone</description>
        </group>
        <group group_id="P3">
          <title>Bupivacaine 0.25% Mixed With 2mg Dexamethasone</title>
          <description>Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml)&#xD;
Bupivacaine 0.25%&#xD;
Dexamethasone</description>
        </group>
        <group group_id="P4">
          <title>Bupivacaine 0.25% Mixed With 4mg Dexamethasone (1ml</title>
          <description>Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml&#xD;
Bupivacaine 0.25%&#xD;
Dexamethasone</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="23"/>
                <participants group_id="P2" count="20"/>
                <participants group_id="P3" count="22"/>
                <participants group_id="P4" count="24"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="20"/>
                <participants group_id="P2" count="17"/>
                <participants group_id="P3" count="19"/>
                <participants group_id="P4" count="20"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
                <participants group_id="P2" count="3"/>
                <participants group_id="P3" count="3"/>
                <participants group_id="P4" count="4"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Bupivacaine 0.25% Mixed With 1ml Normal Saline</title>
          <description>Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group)&#xD;
Bupivacaine 0.25%&#xD;
normal saline: placebo</description>
        </group>
        <group group_id="B2">
          <title>Bupivacaine 0.25% With 1mg Dexamethasone (1ml)</title>
          <description>Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml)&#xD;
Bupivacaine 0.25%&#xD;
Dexamethasone</description>
        </group>
        <group group_id="B3">
          <title>Bupivacaine 0.25% Mixed With 2mg Dexamethasone</title>
          <description>Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml)&#xD;
Bupivacaine 0.25%&#xD;
Dexamethasone</description>
        </group>
        <group group_id="B4">
          <title>Bupivacaine 0.25% Mixed With 4mg Dexamethasone (1ml</title>
          <description>Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml&#xD;
Bupivacaine 0.25%&#xD;
Dexamethasone</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="23"/>
            <count group_id="B2" value="20"/>
            <count group_id="B3" value="22"/>
            <count group_id="B4" value="24"/>
            <count group_id="B5" value="89"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="22"/>
                    <measurement group_id="B4" value="24"/>
                    <measurement group_id="B5" value="89"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                    <measurement group_id="B5" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="47.1" spread="11.3"/>
                    <measurement group_id="B2" value="46.2" spread="11.8"/>
                    <measurement group_id="B3" value="48.8" spread="14.1"/>
                    <measurement group_id="B4" value="53.0" spread="12.5"/>
                    <measurement group_id="B5" value="48.4" spread="12.4"/>
                  </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="5"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="6"/>
                    <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="18"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="16"/>
                    <measurement group_id="B4" value="19"/>
                    <measurement group_id="B5" value="67"/>
                  </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="23"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="22"/>
                    <measurement group_id="B4" value="24"/>
                    <measurement group_id="B5" value="89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="30.4" spread="6.6"/>
                    <measurement group_id="B2" value="29.4" spread="4.0"/>
                    <measurement group_id="B3" value="28.9" spread="4.4"/>
                    <measurement group_id="B4" value="31.0" spread="6.3"/>
                    <measurement group_id="B5" value="30.3" spread="5.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Primary Outcome Variable is Post Operative Sensory Block Duration</title>
        <description>This is defined as time from the completion of the block to the initiation of supplemental analgesia medications after hospital discharge. The patients were evaluated on different days to capture the exact end time, which was the initiation of supplemental analgesia medication. We intentionally contacted patients several times to capture the time as early as possible to minimize recall bias.</description>
        <time_frame>days 1, 2, and day 7</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bupivacaine 0.25% Mixed With 1ml Normal Saline</title>
            <description>Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group)&#xD;
Bupivacaine 0.25%&#xD;
normal saline: placebo</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine 0.25% With 1mg Dexamethasone (1ml)</title>
            <description>Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml)&#xD;
Bupivacaine 0.25%&#xD;
Dexamethasone</description>
          </group>
          <group group_id="O3">
            <title>Bupivacaine 0.25% Mixed With 2mg Dexamethasone</title>
            <description>Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml)&#xD;
Bupivacaine 0.25%&#xD;
Dexamethasone</description>
          </group>
          <group group_id="O4">
            <title>Bupivacaine 0.25% Mixed With 4mg Dexamethasone (1ml</title>
            <description>Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml&#xD;
Bupivacaine 0.25%&#xD;
Dexamethasone</description>
          </group>
        </group_list>
        <measure>
          <title>Primary Outcome Variable is Post Operative Sensory Block Duration</title>
          <description>This is defined as time from the completion of the block to the initiation of supplemental analgesia medications after hospital discharge. The patients were evaluated on different days to capture the exact end time, which was the initiation of supplemental analgesia medication. We intentionally contacted patients several times to capture the time as early as possible to minimize recall bias.</description>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="17"/>
                <count group_id="O3" value="19"/>
                <count group_id="O4" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.1" lower_limit="9.8" upper_limit="20.9"/>
                    <measurement group_id="O2" value="22.3" lower_limit="19.0" upper_limit="24.9"/>
                    <measurement group_id="O3" value="23.3" lower_limit="19.5" upper_limit="26.8"/>
                    <measurement group_id="O4" value="21.2" lower_limit="16.8" upper_limit="23.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>The Secondary Outcome Variable is Post Operative Motor Block Duration</title>
        <description>This is defined as time from the completion of the block to the time when patient is able to move his or her forearm and/or hands. The patients were evaluated on different days to capture the exact end time, which was the initiation of supplemental analgesia medication. We intentionally contacted patients several times to capture the time as early as possible to minimize recall bias.</description>
        <time_frame>days 1, 2, and day 7</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Bupivacaine 0.25% Mixed With 1ml Normal Saline</title>
            <description>Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group)&#xD;
Bupivacaine 0.25%&#xD;
normal saline: placebo</description>
          </group>
          <group group_id="O2">
            <title>Bupivacaine 0.25% With 1mg Dexamethasone (1ml)</title>
            <description>Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml)&#xD;
Bupivacaine 0.25%&#xD;
Dexamethasone</description>
          </group>
          <group group_id="O3">
            <title>Bupivacaine 0.25% Mixed With 2mg Dexamethasone</title>
            <description>Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml)&#xD;
Bupivacaine 0.25%&#xD;
Dexamethasone</description>
          </group>
          <group group_id="O4">
            <title>Bupivacaine 0.25% Mixed With 4mg Dexamethasone (1ml</title>
            <description>Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml&#xD;
Bupivacaine 0.25%&#xD;
Dexamethasone</description>
          </group>
        </group_list>
        <measure>
          <title>The Secondary Outcome Variable is Post Operative Motor Block Duration</title>
          <description>This is defined as time from the completion of the block to the time when patient is able to move his or her forearm and/or hands. The patients were evaluated on different days to capture the exact end time, which was the initiation of supplemental analgesia medication. We intentionally contacted patients several times to capture the time as early as possible to minimize recall bias.</description>
          <units>hours</units>
          <param>Mean</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="20"/>
                <count group_id="O2" value="17"/>
                <count group_id="O3" value="19"/>
                <count group_id="O4" value="20"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.1" lower_limit="8.9" upper_limit="19.4"/>
                    <measurement group_id="O2" value="21" lower_limit="16.8" upper_limit="22.7"/>
                    <measurement group_id="O3" value="20.9" lower_limit="16.1" upper_limit="23.7"/>
                    <measurement group_id="O4" value="19.4" lower_limit="14.9" upper_limit="23.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Bupivacaine 0.25% Mixed With 1ml Normal Saline</title>
          <description>Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group)&#xD;
Bupivacaine 0.25%&#xD;
normal saline: placebo</description>
        </group>
        <group group_id="E2">
          <title>Bupivacaine 0.25% With 1mg Dexamethasone (1ml)</title>
          <description>Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml)&#xD;
Bupivacaine 0.25%&#xD;
Dexamethasone</description>
        </group>
        <group group_id="E3">
          <title>Bupivacaine 0.25% Mixed With 2mg Dexamethasone</title>
          <description>Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml)&#xD;
Bupivacaine 0.25%&#xD;
Dexamethasone</description>
        </group>
        <group group_id="E4">
          <title>Bupivacaine 0.25% Mixed With 4mg Dexamethasone (1ml</title>
          <description>Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml&#xD;
Bupivacaine 0.25%&#xD;
Dexamethasone</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="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="24"/>
              </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="23"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="20"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="22"/>
                <counts group_id="E4" subjects_affected="0" subjects_at_risk="24"/>
              </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>
    <limitations_and_caveats>First, all information was collected via telephone call during the recovery period at home, during which recall may be inaccurate. Second, we did not control the intravenous dexamethasone use, which could potentially affect the analgesia duration.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Jiabin Liu, MD, PhD</name_or_title>
      <organization>the University of Pennsylvania</organization>
      <phone>215-573-8208</phone>
      <email>jiabin.liu@uphs.upenn.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/NCT01690663
org study id: 815628
nct id: NCT01690663
lead sponsor: 
has dmc: Yes
When used in conjunction with a local anesthetic, dexamethasone may prolong both the sensory
      and motor effects of high supraclavicular brachial plexus nerve block (SBP) in arthroscopic
      shoulder surgery. This study seeks to determine if there is a relationship between the
      duration of sensory and motor blockade in supraclavicular brachial plexus nerve blocks (SBP)
      when combined with increasing doses of dexamethasone.
The exact mechanism of dexamethasone on peripheral nerve block is unclear. The current theory
      is that the effect is not dose related, while only 4mg and 8mg doses were studied. Our
      hypothesis is that the dose differences at 1mg, 2mg, or 4mg, does not have significant effect
      on the duration of analgesia. Therefore, we are not considering any patients to receive
      suboptimal dosing of preservative free dexamethasone in this study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Primary Outcome Variable is Post Operative Sensory Block Duration
time frame: days 1, 2, and day 7
description: This is defined as time from the completion of the block to the initiation of supplemental analgesia medications after hospital discharge. The patients were evaluated on different days to capture the exact end time, which was the initiation of supplemental analgesia medication. We intentionally contacted patients several times to capture the time as early as possible to minimize recall bias.
measure: The Secondary Outcome Variable is Post Operative Motor Block Duration
time frame: days 1, 2, and day 7
description: This is defined as time from the completion of the block to the time when patient is able to move his or her forearm and/or hands. The patients were evaluated on different days to capture the exact end time, which was the initiation of supplemental analgesia medication. We intentionally contacted patients several times to capture the time as early as possible to minimize recall bias.
arm group label: Bupivacaine 0.25% mixed with 1ml normal saline
arm group type: Placebo Comparator
description: Bupivacaine 0.25% mixed with 1ml normal saline (placebo/control group)
arm group label: Bupivacaine 0.25% with 1mg dexamethasone (1ml)
arm group type: Active Comparator
description: Bupivacaine 0.25% mixed with 1mg preservative free dexamethasone (1ml)
arm group label: Bupivacaine 0.25% mixed with 2mg dexamethasone
arm group type: Active Comparator
description: Bupivacaine 0.25% mixed with 2mg preservative free dexamethasone (1ml)
arm group label: Bupivacaine 0.25% mixed with 4mg dexamethasone (1ml
arm group type: Active Comparator
description: Bupivacaine 0.25% mixed with 4mg preservative free dexamethasone (1ml
intervention type: Drug
intervention name: Bupivacaine 0.25%
arm group label: Bupivacaine 0.25% mixed with 1ml normal saline
arm group label: Bupivacaine 0.25% mixed with 2mg dexamethasone
arm group label: Bupivacaine 0.25% mixed with 4mg dexamethasone (1ml
arm group label: Bupivacaine 0.25% with 1mg dexamethasone (1ml)
intervention type: Drug
intervention name: Dexamethasone
arm group label: Bupivacaine 0.25% mixed with 2mg dexamethasone
arm group label: Bupivacaine 0.25% mixed with 4mg dexamethasone (1ml
arm group label: Bupivacaine 0.25% with 1mg dexamethasone (1ml)
intervention type: Drug
intervention name: normal saline
description: placebo
arm group label: Bupivacaine 0.25% mixed with 1ml normal saline
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Jiabin Liu, MD
role: Principal Investigator
affiliation: University of Pennsylvania
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Dexamethasone
mesh term: Bupivacaine
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: First, all information was collected via telephone call during the recovery period at home, during which recall may be inaccurate. Second, we did not control the intravenous dexamethasone use, which could potentially affect the analgesia duration.
point of contact: 