<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/NCT01701115</url>
  </required_header>
  <id_info>
    <org_study_id>2012-011</org_study_id>
    <nct_id>NCT01701115</nct_id>
  </id_info>
  <brief_title>Effect of Local Anesthetic Dose on Interscalene Block</brief_title>
  <acronym>Low Dose ISB</acronym>
  <official_title>Effect of Local Anesthetic Dose on Interscalene Block for Shoulder Arthroscopy, Patient Satisfaction and Return of Handgrip Strength</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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if a decrease in the standard volume of local&#xD;
      anesthetic used to numb your shoulder area before shoulder arthroscopy will provide adequate&#xD;
      anesthesia for the procedure and decrease the amount of time until you are ready for&#xD;
      discharge from the hospital.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Traditionally, an interscalene block is done either with nerve stimulator or ultrasound&#xD;
      guided using 40-60mL of local anesthetic. The study plans to investigate the difference in&#xD;
      hand grip strength post-operatively in patients who will receive interscalene blocks with&#xD;
      40mL versus a lower dose (20mL) of local anesthetic. We suspect the lower dose will achieve&#xD;
      adequate surgical anesthesia while creating less motor block and thus, increase patient&#xD;
      satisfaction, present fewer complications or adverse affects and decrease time in the&#xD;
      recovery room.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</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>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Handgrip Strength</measure>
    <time_frame>Difference between between baseline and postoperative.</time_frame>
    <description>The primary outcome will be handgrip strength as measured by a dynamometer. A reading will be obtained at baseline (before the interscalene block) and 60 minutes post-operative.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Readiness to Discharge</measure>
    <time_frame>Participants will be followed every 15 minutes post-surgery until discharged from the hospital (up to 180 minutes)</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of Analgesia</measure>
    <time_frame>Postoperative Day 2</time_frame>
    <description>Time to pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Side Effects</measure>
    <time_frame>Postoperative Day 2</time_frame>
    <description>Incidence of nausea</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">154</enrollment>
  <condition>Shoulder Arthroscopy</condition>
  <condition>Interscalene Block</condition>
  <arm_group>
    <arm_group_label>Low Dose (20 mL) Local Anesthetic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Intervention to be administered is a total volume of 20 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Dose (40 mL) Local Anesthetic</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intervention to be administered is a total volume of 40 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Low Dose (20 ml) Local Anesthetic Volume for Interscalene Block</intervention_name>
    <description>Anesthetic volume:&#xD;
Investigational group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 20 mL</description>
    <arm_group_label>Low Dose (20 mL) Local Anesthetic</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Control Dose (40 mL) Local Anesthetic Volume for Interscalene Block</intervention_name>
    <description>Anesthetic volume:&#xD;
Control group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 40 mL</description>
    <arm_group_label>Control Dose (40 mL) Local Anesthetic</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Low Dose (20 mL) Local Anesthetic (Mepivacaine:Bupivacaine)</intervention_name>
    <arm_group_label>Low Dose (20 mL) Local Anesthetic</arm_group_label>
    <other_name>Mepivacaine</other_name>
    <other_name>Bupivacaine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Control Dose (40 mL) Local Anesthetic (Mepivacaine:Bupivacaine)</intervention_name>
    <arm_group_label>Control Dose (40 mL) Local Anesthetic</arm_group_label>
    <other_name>Mepivacaine</other_name>
    <other_name>Bupivacaine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age: 18 - 80 years old&#xD;
&#xD;
          -  Surgical time &lt; 2.5 hours&#xD;
&#xD;
          -  ASA I, II or III&#xD;
&#xD;
          -  Shoulder arthroscopy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 or &gt; 80 years old&#xD;
&#xD;
          -  Chronic pain patients (on narcotics/opioids &gt; 3 months)&#xD;
&#xD;
          -  Open shoulder surgical procedure&#xD;
&#xD;
          -  BMI &gt; 40&#xD;
&#xD;
          -  Pre-existing neurological condition&#xD;
&#xD;
          -  Patient refusal of interscalene block&#xD;
&#xD;
          -  Severe respiratory disease or hemidiaphragmatic dysfunction&#xD;
&#xD;
          -  Allergy to any local anesthetics&#xD;
&#xD;
          -  Planned general anesthesia&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 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>October 2017</verification_date>
  <study_first_submitted>September 24, 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>April 3, 2017</results_first_submitted>
  <results_first_submitted_qc>October 2, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">October 4, 2017</results_first_posted>
  <last_update_submitted>October 2, 2017</last_update_submitted>
  <last_update_submitted_qc>October 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Interscalene Block</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
    <mesh_term>Anesthetics, Local</mesh_term>
    <mesh_term>Mepivacaine</mesh_term>
    <mesh_term>Anesthetics</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Low Dose (20 mL) Local Anesthetic</title>
          <description>Intervention to be administered is a total volume of 20 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine.&#xD;
Low Dose (20 ml) Local Anesthetic Volume for Interscalene Block: Anesthetic volume:&#xD;
Investigational group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 20 mL&#xD;
Low Dose (20 mL) Local Anesthetic (Mepivacaine:Bupivacaine)</description>
        </group>
        <group group_id="P2">
          <title>Control Dose (40 mL) Local Anesthetic</title>
          <description>Intervention to be administered is a total volume of 40 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine&#xD;
Control Dose (40 mL) Local Anesthetic Volume for Interscalene Block: Anesthetic volume:&#xD;
Control group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 40 mL&#xD;
Control Dose (40 mL) Local Anesthetic (Mepivacaine:Bupivacaine)</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="77"/>
                <participants group_id="P2" count="77"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="75"/>
                <participants group_id="P2" count="77"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="2"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Low Dose (20 mL) Local Anesthetic</title>
          <description>Intervention to be administered is a total volume of 20 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine.&#xD;
Low Dose (20 ml) Local Anesthetic Volume for Interscalene Block: Anesthetic volume:&#xD;
Investigational group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 20 mL&#xD;
Low Dose (20 mL) Local Anesthetic (Mepivacaine:Bupivacaine)</description>
        </group>
        <group group_id="B2">
          <title>Control Dose (40 mL) Local Anesthetic</title>
          <description>Intervention to be administered is a total volume of 40 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine&#xD;
Control Dose (40 mL) Local Anesthetic Volume for Interscalene Block: Anesthetic volume:&#xD;
Control group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 40 mL&#xD;
Control Dose (40 mL) Local Anesthetic (Mepivacaine:Bupivacaine)</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="75"/>
            <count group_id="B2" value="77"/>
            <count group_id="B3" value="152"/>
          </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="51.1" spread="14.5"/>
                    <measurement group_id="B2" value="50" spread="14.3"/>
                    <measurement group_id="B3" value="50.6" spread="14.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex/Gender, Customized</title>
          <units>Percentage of participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Female</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25.3"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="25.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Male</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="74.7"/>
                    <measurement group_id="B2" value="74"/>
                    <measurement group_id="B3" value="74.3"/>
                  </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="75"/>
                    <measurement group_id="B2" value="77"/>
                    <measurement group_id="B3" value="152"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index (BMI)</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="27.6" spread="4.2"/>
                    <measurement group_id="B2" value="26.3" spread="3.7"/>
                    <measurement group_id="B3" value="26.8" spread="3.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Handgrip Strength</title>
        <description>The primary outcome will be handgrip strength as measured by a dynamometer. A reading will be obtained at baseline (before the interscalene block) and 60 minutes post-operative.</description>
        <time_frame>Difference between between baseline and postoperative.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low Dose (20 mL) Local Anesthetic</title>
            <description>Intervention to be administered is a total volume of 20 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine.&#xD;
Low Dose (20 ml) Local Anesthetic Volume for Interscalene Block: Anesthetic volume:&#xD;
Investigational group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 20 mL&#xD;
Low Dose (20 mL) Local Anesthetic (Mepivacaine:Bupivacaine)</description>
          </group>
          <group group_id="O2">
            <title>Control Dose (40 mL) Local Anesthetic</title>
            <description>Intervention to be administered is a total volume of 40 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine&#xD;
Control Dose (40 mL) Local Anesthetic Volume for Interscalene Block: Anesthetic volume:&#xD;
Control group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 40 mL&#xD;
Control Dose (40 mL) Local Anesthetic (Mepivacaine:Bupivacaine)</description>
          </group>
        </group_list>
        <measure>
          <title>Handgrip Strength</title>
          <description>The primary outcome will be handgrip strength as measured by a dynamometer. A reading will be obtained at baseline (before the interscalene block) and 60 minutes post-operative.</description>
          <units>kg</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="75"/>
                <count group_id="O2" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.45" spread="1.6"/>
                    <measurement group_id="O2" value="2.98" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Readiness to Discharge</title>
        <time_frame>Participants will be followed every 15 minutes post-surgery until discharged from the hospital (up to 180 minutes)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low Dose (20 mL) Local Anesthetic</title>
            <description>Intervention to be administered is a total volume of 20 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine.&#xD;
Low Dose (20 ml) Local Anesthetic Volume for Interscalene Block: Anesthetic volume:&#xD;
Investigational group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 20 mL&#xD;
Low Dose (20 mL) Local Anesthetic (Mepivacaine:Bupivacaine)</description>
          </group>
          <group group_id="O2">
            <title>Control Dose (40 mL) Local Anesthetic</title>
            <description>Intervention to be administered is a total volume of 40 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine&#xD;
Control Dose (40 mL) Local Anesthetic Volume for Interscalene Block: Anesthetic volume:&#xD;
Control group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 40 mL&#xD;
Control Dose (40 mL) Local Anesthetic (Mepivacaine:Bupivacaine)</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Readiness to Discharge</title>
          <units>minutes</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="75"/>
                <count group_id="O2" value="77"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60" spread="5"/>
                    <measurement group_id="O2" value="65" spread="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Duration of Analgesia</title>
        <description>Time to pain</description>
        <time_frame>Postoperative Day 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low Dose (20 mL) Local Anesthetic</title>
            <description>Intervention to be administered is a total volume of 20 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine.&#xD;
Low Dose (20 ml) Local Anesthetic Volume for Interscalene Block: Anesthetic volume:&#xD;
Investigational group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 20 mL&#xD;
Low Dose (20 mL) Local Anesthetic (Mepivacaine:Bupivacaine)</description>
          </group>
          <group group_id="O2">
            <title>Control Dose (40 mL) Local Anesthetic</title>
            <description>Intervention to be administered is a total volume of 40 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine&#xD;
Control Dose (40 mL) Local Anesthetic Volume for Interscalene Block: Anesthetic volume:&#xD;
Control group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 40 mL&#xD;
Control Dose (40 mL) Local Anesthetic (Mepivacaine:Bupivacaine)</description>
          </group>
        </group_list>
        <measure>
          <title>Duration of Analgesia</title>
          <description>Time to pain</description>
          <units>minutes</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="49"/>
                <count group_id="O2" value="43"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="993" lower_limit="635" upper_limit="1119"/>
                    <measurement group_id="O2" value="960" lower_limit="759" upper_limit="1340"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Side Effects</title>
        <description>Incidence of nausea</description>
        <time_frame>Postoperative Day 2</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Low Dose (20 mL) Local Anesthetic</title>
            <description>Intervention to be administered is a total volume of 20 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine.&#xD;
Low Dose (20 ml) Local Anesthetic Volume for Interscalene Block: Anesthetic volume:&#xD;
Investigational group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 20 mL&#xD;
Low Dose (20 mL) Local Anesthetic (Mepivacaine:Bupivacaine)</description>
          </group>
          <group group_id="O2">
            <title>Control Dose (40 mL) Local Anesthetic</title>
            <description>Intervention to be administered is a total volume of 40 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine&#xD;
Control Dose (40 mL) Local Anesthetic Volume for Interscalene Block: Anesthetic volume:&#xD;
Control group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 40 mL&#xD;
Control Dose (40 mL) Local Anesthetic (Mepivacaine:Bupivacaine)</description>
          </group>
        </group_list>
        <measure>
          <title>Side Effects</title>
          <description>Incidence of nausea</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="55"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Low Dose (20 mL) Local Anesthetic</title>
          <description>Intervention to be administered is a total volume of 20 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine.&#xD;
Low Dose (20 ml) Local Anesthetic Volume for Interscalene Block: Anesthetic volume:&#xD;
Investigational group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 20 mL&#xD;
Low Dose (20 mL) Local Anesthetic (Mepivacaine:Bupivacaine)</description>
        </group>
        <group group_id="E2">
          <title>Control Dose (40 mL) Local Anesthetic</title>
          <description>Intervention to be administered is a total volume of 40 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine&#xD;
Control Dose (40 mL) Local Anesthetic Volume for Interscalene Block: Anesthetic volume:&#xD;
Control group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 40 mL&#xD;
Control Dose (40 mL) Local Anesthetic (Mepivacaine:Bupivacaine)</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="75"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="77"/>
              </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="75"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="77"/>
              </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. Daniel Maalouf</name_or_title>
      <organization>HSS</organization>
      <phone>(212) 606-1000</phone>
      <email>MaaloufD@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/NCT01701115
org study id: 2012-011
nct id: NCT01701115
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine if a decrease in the standard volume of local
      anesthetic used to numb your shoulder area before shoulder arthroscopy will provide adequate
      anesthesia for the procedure and decrease the amount of time until you are ready for
      discharge from the hospital.
Traditionally, an interscalene block is done either with nerve stimulator or ultrasound
      guided using 40-60mL of local anesthetic. The study plans to investigate the difference in
      hand grip strength post-operatively in patients who will receive interscalene blocks with
      40mL versus a lower dose (20mL) of local anesthetic. We suspect the lower dose will achieve
      adequate surgical anesthesia while creating less motor block and thus, increase patient
      satisfaction, present fewer complications or adverse affects and decrease time in the
      recovery room.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Handgrip Strength
time frame: Difference between between baseline and postoperative.
description: The primary outcome will be handgrip strength as measured by a dynamometer. A reading will be obtained at baseline (before the interscalene block) and 60 minutes post-operative.
measure: Patient Readiness to Discharge
time frame: Participants will be followed every 15 minutes post-surgery until discharged from the hospital (up to 180 minutes)
measure: Duration of Analgesia
time frame: Postoperative Day 2
description: Time to pain
measure: Side Effects
time frame: Postoperative Day 2
description: Incidence of nausea
arm group label: Low Dose (20 mL) Local Anesthetic
arm group type: Experimental
description: Intervention to be administered is a total volume of 20 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine.
arm group label: Control Dose (40 mL) Local Anesthetic
arm group type: Active Comparator
description: Intervention to be administered is a total volume of 40 mL local anesthetic containing a 1:1 mixture of 1.5% Mepivacaine: 0.5% Bupivacaine
intervention type: Procedure
intervention name: Low Dose (20 ml) Local Anesthetic Volume for Interscalene Block
description: Anesthetic volume:
Investigational group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 20 mL
arm group label: Low Dose (20 mL) Local Anesthetic
intervention type: Procedure
intervention name: Control Dose (40 mL) Local Anesthetic Volume for Interscalene Block
description: Anesthetic volume:
Control group: A 1:1 Mepivacaine 1.5%: Bupivacaine 0.5% mixture for a total of 40 mL
arm group label: Control Dose (40 mL) Local Anesthetic
intervention type: Drug
intervention name: Low Dose (20 mL) Local Anesthetic (Mepivacaine:Bupivacaine)
arm group label: Low Dose (20 mL) Local Anesthetic
other name: Mepivacaine
other name: Bupivacaine
intervention type: Drug
intervention name: Control Dose (40 mL) Local Anesthetic (Mepivacaine:Bupivacaine)
arm group label: Control Dose (40 mL) Local Anesthetic
other name: Mepivacaine
other name: Bupivacaine
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Sponsor
mesh term: Bupivacaine
mesh term: Anesthetics, Local
mesh term: Mepivacaine
mesh term: Anesthetics
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 