<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/NCT03272139</url>
  </required_header>
  <id_info>
    <org_study_id>2017-0979</org_study_id>
    <nct_id>NCT03272139</nct_id>
  </id_info>
  <brief_title>Interscalene Block Versus Superior Trunk Block</brief_title>
  <acronym>STB</acronym>
  <official_title>Interscalene Block Versus Superior Trunk Block: A Randomized Controlled Clinical Trial</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>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Sparing the phrenic nerve by administering ultrasound-guided low volume superior trunk block&#xD;
      (STB) and interscalene block (ISB) for arthroscopic shoulder surgery (labral repair,&#xD;
      stabilization, rotator cuff repair).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 28, 2017</start_date>
  <completion_date type="Actual">July 9, 2019</completion_date>
  <primary_completion_date type="Actual">December 30, 2018</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Incidence of Hemidiaphragmatic Paralysis (HDP)</measure>
    <time_frame>Day of Surgery, diagnosis confirmed from trained anesthesiologist ultrasound readers</time_frame>
    <description>Our primary outcome will be the incidence of hemidiaphragmatic paralysis (HDP) with superior trunk block and interscalene blocks as measured by ultrasound before and after the surgery.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Numerical Pain Rating System (NRS) Pain Scores</measure>
    <time_frame>Average pain scores at rest recorded Day of Surgery every 30 minutes until discharge according to Post Anaesthetic Discharge Scoring System</time_frame>
    <description>Numerical Pain Rating System Pain scores after the superior trunk block and interscalene block at rest measured after the surgery every 30 minute until discharge according to the Post Anaesthetic Discharge Scoring System.&#xD;
Numerical Rating Scale 0-10; with 0 being no pain and 10 pain as bad as you can imagine.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Block Duration</measure>
    <time_frame>Time of block wearing off recorded on Post Operative Day 1 and Post Operative Day 2 as reported via patient phone call.</time_frame>
    <description>Length of nerve block reported by Phone call on POD 1 and POD 2 by patient phone call</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">126</enrollment>
  <condition>Joint Disease</condition>
  <condition>Pain</condition>
  <condition>Pain, Acute</condition>
  <condition>Pain, Chronic</condition>
  <arm_group>
    <arm_group_label>interscalene block (ISB)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The interscalene block will be done using an ultrasound-guided, in-plane approach. The anesthesiologists will target below the C5 nerve root. A 22 gauge 1.5-2 inch needle is advanced in-plane from lateral to medial through the middle scalene muscle until the needle tip is positioned in the interscalene groove between the C5 and C6 nerve roots. 15 20 ml of 0.5% bupivacaine will be injected.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>superior trunk block (STB)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The superior trunk block will be performed at the point immediately distal to the roots when the c5-c6 form the superior trunk and lies anterior to the middle scalene muscle and below the deep cervical fascia, before the suprascapular nerve arises and goes into the omohyoid. A 22g 1.5-2inch needle will be advanced in-plane from lateral to medial. The needle tip will be placed lateral to the superior trunk and 15 20 ml of 0.5% bupivacaine will be injected just inferior to the deep cervical fasica. Local circumferential spread will be achieved both anterior and posterior to the superior trunk.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine</intervention_name>
    <description>Anesthetic that will help treat pain and sensation after shoulder arthroscopy</description>
    <arm_group_label>interscalene block (ISB)</arm_group_label>
    <arm_group_label>superior trunk block (STB)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ultrasound</intervention_name>
    <description>Ultrasound will help guide the anesthesiologist in performing the different nerve blocks</description>
    <arm_group_label>interscalene block (ISB)</arm_group_label>
    <arm_group_label>superior trunk block (STB)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients who will be undergoing primary unilateral labral repair/stabilization of the&#xD;
             shoulder&#xD;
&#xD;
          -  Age 18 to 80 years&#xD;
&#xD;
          -  Planned use of general anesthesia with LMA and interscalene or superior trunk block&#xD;
&#xD;
          -  Ability to follow study protocol&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
          -  ASA I - III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Pre-existing neuropathy of the operative limb&#xD;
&#xD;
          -  Younger than 18 years old and older than 80&#xD;
&#xD;
          -  Patients with pulmonary severe respiratory disease&#xD;
&#xD;
          -  Allergy to one of the study medications&#xD;
&#xD;
          -  Chronic gabapentin/pregabalin use (regular use for longer than 3 months)&#xD;
&#xD;
          -  Chronic opioid use (taking opioids for longer than 3 months)&#xD;
&#xD;
          -  Contraindication to general anesthesia, interscalene or superior trunk block&#xD;
&#xD;
          -  Herniated Cervical Disk, Cervical Myelopathy&#xD;
&#xD;
          -  BMI &gt;35&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>David H Kim, MD</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>April 2022</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <results_first_submitted>March 12, 2020</results_first_submitted>
  <results_first_submitted_qc>April 17, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">April 29, 2020</results_first_posted>
  <last_update_submitted>April 19, 2022</last_update_submitted>
  <last_update_submitted_qc>April 19, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2022</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>Joint Diseases</mesh_term>
    <mesh_term>Acute Pain</mesh_term>
    <mesh_term>Chronic Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 3, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/39/NCT03272139/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Interscalene Block (ISB)</title>
          <description>The interscalene block will be done using an ultrasound-guided, in-plane approach. The anesthesiologists will target below the C5 nerve root. A 22 gauge 1.5-2 inch needle is advanced in-plane from lateral to medial through the middle scalene muscle until the needle tip is positioned in the interscalene groove between the C5 and C6 nerve roots. 15 20 ml of 0.5% bupivacaine will be injected.&#xD;
Bupivacaine: Anesthetic that will help treat pain and sensation after shoulder arthroscopy&#xD;
Ultrasound: Ultrasound will help guide the anesthesiologist in performing the different nerve blocks</description>
        </group>
        <group group_id="P2">
          <title>Superior Trunk Block (STB)</title>
          <description>The superior trunk block will be performed at the point immediately distal to the roots when the c5-c6 form the superior trunk and lies anterior to the middle scalene muscle and below the deep cervical fascia, before the suprascapular nerve arises and goes into the omohyoid. A 22g 1.5-2inch needle will be advanced in-plane from lateral to medial. The needle tip will be placed lateral to the superior trunk and 15 20 ml of 0.5% bupivacaine will be injected just inferior to the deep cervical fasica. Local circumferential spread will be achieved both anterior and posterior to the superior trunk.&#xD;
Bupivacaine: Anesthetic that will help treat pain and sensation after shoulder arthroscopy&#xD;
Ultrasound: Ultrasound will help guide the anesthesiologist in performing the different nerve blocks</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="63"/>
                <participants group_id="P2" count="63"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="63"/>
                <participants group_id="P2" count="63"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Interscalene Block (ISB)</title>
          <description>The interscalene block will be done using an ultrasound-guided, in-plane approach. The anesthesiologists will target below the C5 nerve root. A 22 gauge 1.5-2 inch needle is advanced in-plane from lateral to medial through the middle scalene muscle until the needle tip is positioned in the interscalene groove between the C5 and C6 nerve roots. 15 20 ml of 0.5% bupivacaine will be injected.&#xD;
Bupivacaine: Anesthetic that will help treat pain and sensation after shoulder arthroscopy&#xD;
Ultrasound: Ultrasound will help guide the anesthesiologist in performing the different nerve blocks</description>
        </group>
        <group group_id="B2">
          <title>Superior Trunk Block (STB)</title>
          <description>The superior trunk block will be performed at the point immediately distal to the roots when the c5-c6 form the superior trunk and lies anterior to the middle scalene muscle and below the deep cervical fascia, before the suprascapular nerve arises and goes into the omohyoid. A 22g 1.5-2inch needle will be advanced in-plane from lateral to medial. The needle tip will be placed lateral to the superior trunk and 15 20 ml of 0.5% bupivacaine will be injected just inferior to the deep cervical fasica. Local circumferential spread will be achieved both anterior and posterior to the superior trunk.&#xD;
Bupivacaine: Anesthetic that will help treat pain and sensation after shoulder arthroscopy&#xD;
Ultrasound: Ultrasound will help guide the anesthesiologist in performing the different nerve blocks</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="63"/>
            <count group_id="B2" value="63"/>
            <count group_id="B3" value="126"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50.0" lower_limit="38.0" upper_limit="59.0"/>
                    <measurement group_id="B2" value="51.5" lower_limit="37.0" upper_limit="60.0"/>
                    <measurement group_id="B3" value="51" lower_limit="37" upper_limit="59"/>
                  </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="19"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="116"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                    <measurement group_id="B2" value="54"/>
                    <measurement group_id="B3" value="106"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>BMI</title>
          <units>kg/m^2</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26.8" lower_limit="24.4" upper_limit="29.6"/>
                    <measurement group_id="B2" value="27.2" lower_limit="24.8" upper_limit="29.8"/>
                    <measurement group_id="B3" value="26.8" lower_limit="24.8" upper_limit="29.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Length of Surgery</title>
          <units>minutes</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46.0" lower_limit="35.0" upper_limit="66.0"/>
                    <measurement group_id="B2" value="49.0" lower_limit="32.0" upper_limit="62.0"/>
                    <measurement group_id="B3" value="48" lower_limit="33" upper_limit="63"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>ASA Class</title>
          <description>ASA Classification System is to assess and communicate a patient's pre-anesthesia medical co-morbidities. ASA1 is a normal healthy patient. ASA2 is a patient with mild systemic disease and ASA3 is a patient with severe systemic disease.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>ASA 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ASA 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="52"/>
                    <measurement group_id="B3" value="96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>ASA 3</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Laterality</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>LEFT Shoulder Arthroscopy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Right Shoulder Arthroscopy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline NRS</title>
          <description>Numerical Rating Scale 0-10; with 0 being no pain and 10 pain as bad as you can imagine.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.0" lower_limit="0" upper_limit="3.0"/>
                    <measurement group_id="B2" value="2.0" lower_limit="0" upper_limit="3.0"/>
                    <measurement group_id="B3" value="2.0" lower_limit="0" upper_limit="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Incidence of Hemidiaphragmatic Paralysis (HDP)</title>
        <description>Our primary outcome will be the incidence of hemidiaphragmatic paralysis (HDP) with superior trunk block and interscalene blocks as measured by ultrasound before and after the surgery.</description>
        <time_frame>Day of Surgery, diagnosis confirmed from trained anesthesiologist ultrasound readers</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Interscalene Block (ISB)</title>
            <description>The interscalene block will be done using an ultrasound-guided, in-plane approach. The anesthesiologists will target below the C5 nerve root. A 22 gauge 1.5-2 inch needle is advanced in-plane from lateral to medial through the middle scalene muscle until the needle tip is positioned in the interscalene groove between the C5 and C6 nerve roots. 15 20 ml of 0.5% bupivacaine will be injected.&#xD;
Bupivacaine: Anesthetic that will help treat pain and sensation after shoulder arthroscopy&#xD;
Ultrasound: Ultrasound will help guide the anesthesiologist in performing the different nerve blocks</description>
          </group>
          <group group_id="O2">
            <title>Superior Trunk Block (STB)</title>
            <description>The superior trunk block will be performed at the point immediately distal to the roots when the c5-c6 form the superior trunk and lies anterior to the middle scalene muscle and below the deep cervical fascia, before the suprascapular nerve arises and goes into the omohyoid. A 22g 1.5-2inch needle will be advanced in-plane from lateral to medial. The needle tip will be placed lateral to the superior trunk and 15 20 ml of 0.5% bupivacaine will be injected just inferior to the deep cervical fasica. Local circumferential spread will be achieved both anterior and posterior to the superior trunk.&#xD;
Bupivacaine: Anesthetic that will help treat pain and sensation after shoulder arthroscopy&#xD;
Ultrasound: Ultrasound will help guide the anesthesiologist in performing the different nerve blocks</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Incidence of Hemidiaphragmatic Paralysis (HDP)</title>
          <description>Our primary outcome will be the incidence of hemidiaphragmatic paralysis (HDP) with superior trunk block and interscalene blocks as measured by ultrasound before and after the surgery.</description>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>HDP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="45"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No HDP</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18"/>
                    <measurement group_id="O2" value="59"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Numerical Pain Rating System (NRS) Pain Scores</title>
        <description>Numerical Pain Rating System Pain scores after the superior trunk block and interscalene block at rest measured after the surgery every 30 minute until discharge according to the Post Anaesthetic Discharge Scoring System.&#xD;
Numerical Rating Scale 0-10; with 0 being no pain and 10 pain as bad as you can imagine.</description>
        <time_frame>Average pain scores at rest recorded Day of Surgery every 30 minutes until discharge according to Post Anaesthetic Discharge Scoring System</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Interscalene Block (ISB)</title>
            <description>The interscalene block will be done using an ultrasound-guided, in-plane approach. The anesthesiologists will target below the C5 nerve root. A 22 gauge 1.5-2 inch needle is advanced in-plane from lateral to medial through the middle scalene muscle until the needle tip is positioned in the interscalene groove between the C5 and C6 nerve roots. 15 20 ml of 0.5% bupivacaine will be injected.&#xD;
Bupivacaine: Anesthetic that will help treat pain and sensation after shoulder arthroscopy&#xD;
Ultrasound: Ultrasound will help guide the anesthesiologist in performing the different nerve blocks</description>
          </group>
          <group group_id="O2">
            <title>Superior Trunk Block (STB)</title>
            <description>The superior trunk block will be performed at the point immediately distal to the roots when the c5-c6 form the superior trunk and lies anterior to the middle scalene muscle and below the deep cervical fascia, before the suprascapular nerve arises and goes into the omohyoid. A 22g 1.5-2inch needle will be advanced in-plane from lateral to medial. The needle tip will be placed lateral to the superior trunk and 15 20 ml of 0.5% bupivacaine will be injected just inferior to the deep cervical fasica. Local circumferential spread will be achieved both anterior and posterior to the superior trunk.&#xD;
Bupivacaine: Anesthetic that will help treat pain and sensation after shoulder arthroscopy&#xD;
Ultrasound: Ultrasound will help guide the anesthesiologist in performing the different nerve blocks</description>
          </group>
        </group_list>
        <measure>
          <title>Numerical Pain Rating System (NRS) Pain Scores</title>
          <description>Numerical Pain Rating System Pain scores after the superior trunk block and interscalene block at rest measured after the surgery every 30 minute until discharge according to the Post Anaesthetic Discharge Scoring System.&#xD;
Numerical Rating Scale 0-10; with 0 being no pain and 10 pain as bad as you can imagine.</description>
          <units>units on a scale</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="63"/>
                <count group_id="O2" value="62"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" lower_limit="0" upper_limit="2"/>
                    <measurement group_id="O2" value="0" lower_limit="0" upper_limit="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Block Duration</title>
        <description>Length of nerve block reported by Phone call on POD 1 and POD 2 by patient phone call</description>
        <time_frame>Time of block wearing off recorded on Post Operative Day 1 and Post Operative Day 2 as reported via patient phone call.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Interscalene Block (ISB)</title>
            <description>The interscalene block will be done using an ultrasound-guided, in-plane approach. The anesthesiologists will target below the C5 nerve root. A 22 gauge 1.5-2 inch needle is advanced in-plane from lateral to medial through the middle scalene muscle until the needle tip is positioned in the interscalene groove between the C5 and C6 nerve roots. 15 20 ml of 0.5% bupivacaine will be injected.&#xD;
Bupivacaine: Anesthetic that will help treat pain and sensation after shoulder arthroscopy&#xD;
Ultrasound: Ultrasound will help guide the anesthesiologist in performing the different nerve blocks</description>
          </group>
          <group group_id="O2">
            <title>Superior Trunk Block (STB)</title>
            <description>The superior trunk block will be performed at the point immediately distal to the roots when the c5-c6 form the superior trunk and lies anterior to the middle scalene muscle and below the deep cervical fascia, before the suprascapular nerve arises and goes into the omohyoid. A 22g 1.5-2inch needle will be advanced in-plane from lateral to medial. The needle tip will be placed lateral to the superior trunk and 15 20 ml of 0.5% bupivacaine will be injected just inferior to the deep cervical fasica. Local circumferential spread will be achieved both anterior and posterior to the superior trunk.&#xD;
Bupivacaine: Anesthetic that will help treat pain and sensation after shoulder arthroscopy&#xD;
Ultrasound: Ultrasound will help guide the anesthesiologist in performing the different nerve blocks</description>
          </group>
        </group_list>
        <measure>
          <title>Block Duration</title>
          <description>Length of nerve block reported by Phone call on POD 1 and POD 2 by patient phone call</description>
          <units>Hours</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="61"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.18" lower_limit="19.95" upper_limit="25.53"/>
                    <measurement group_id="O2" value="23.15" lower_limit="19.12" upper_limit="30.07"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>From Post Op Day 1 to Post Op Day 7</time_frame>
      <desc>Incidence of paresthesia / neuropraxia ( POD1, POD ): persistent tingling, numbness in POD1, if patient reports persistent neuropraxia after POD2, will follow up on POD7. If persists, will notify attending anesthesiologist and continue to follow until postoperative neurologic symptoms (PONS) resolves.</desc>
      <group_list>
        <group group_id="E1">
          <title>Interscalene Block (ISB)</title>
          <description>The interscalene block will be done using an ultrasound-guided, in-plane approach. The anesthesiologists will target below the C5 nerve root. A 22 gauge 1.5-2 inch needle is advanced in-plane from lateral to medial through the middle scalene muscle until the needle tip is positioned in the interscalene groove between the C5 and C6 nerve roots. 15 20 ml of 0.5% bupivacaine will be injected.&#xD;
Bupivacaine: Anesthetic that will help treat pain and sensation after shoulder arthroscopy&#xD;
Ultrasound: Ultrasound will help guide the anesthesiologist in performing the different nerve blocks</description>
        </group>
        <group group_id="E2">
          <title>Superior Trunk Block (STB)</title>
          <description>The superior trunk block will be performed at the point immediately distal to the roots when the c5-c6 form the superior trunk and lies anterior to the middle scalene muscle and below the deep cervical fascia, before the suprascapular nerve arises and goes into the omohyoid. A 22g 1.5-2inch needle will be advanced in-plane from lateral to medial. The needle tip will be placed lateral to the superior trunk and 15 20 ml of 0.5% bupivacaine will be injected just inferior to the deep cervical fasica. Local circumferential spread will be achieved both anterior and posterior to the superior trunk.&#xD;
Bupivacaine: Anesthetic that will help treat pain and sensation after shoulder arthroscopy&#xD;
Ultrasound: Ultrasound will help guide the anesthesiologist in performing the different nerve blocks</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
              </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="63"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="63"/>
              </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. David Kim</name_or_title>
      <organization>Department of Anesthesiology, Critical Care &amp; Pain Management</organization>
      <phone>212-606-1206</phone>
      <email>kimd@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/NCT03272139
org study id: 2017-0979
nct id: NCT03272139
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
Sparing the phrenic nerve by administering ultrasound-guided low volume superior trunk block
      (STB) and interscalene block (ISB) for arthroscopic shoulder surgery (labral repair,
      stabilization, rotator cuff repair).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Number of Participants With Incidence of Hemidiaphragmatic Paralysis (HDP)
time frame: Day of Surgery, diagnosis confirmed from trained anesthesiologist ultrasound readers
description: Our primary outcome will be the incidence of hemidiaphragmatic paralysis (HDP) with superior trunk block and interscalene blocks as measured by ultrasound before and after the surgery.
measure: Numerical Pain Rating System (NRS) Pain Scores
time frame: Average pain scores at rest recorded Day of Surgery every 30 minutes until discharge according to Post Anaesthetic Discharge Scoring System
description: Numerical Pain Rating System Pain scores after the superior trunk block and interscalene block at rest measured after the surgery every 30 minute until discharge according to the Post Anaesthetic Discharge Scoring System.
Numerical Rating Scale 0-10; with 0 being no pain and 10 pain as bad as you can imagine.
measure: Block Duration
time frame: Time of block wearing off recorded on Post Operative Day 1 and Post Operative Day 2 as reported via patient phone call.
description: Length of nerve block reported by Phone call on POD 1 and POD 2 by patient phone call
arm group label: interscalene block (ISB)
arm group type: Experimental
description: The interscalene block will be done using an ultrasound-guided, in-plane approach. The anesthesiologists will target below the C5 nerve root. A 22 gauge 1.5-2 inch needle is advanced in-plane from lateral to medial through the middle scalene muscle until the needle tip is positioned in the interscalene groove between the C5 and C6 nerve roots. 15 20 ml of 0.5% bupivacaine will be injected.
arm group label: superior trunk block (STB)
arm group type: Experimental
description: The superior trunk block will be performed at the point immediately distal to the roots when the c5-c6 form the superior trunk and lies anterior to the middle scalene muscle and below the deep cervical fascia, before the suprascapular nerve arises and goes into the omohyoid. A 22g 1.5-2inch needle will be advanced in-plane from lateral to medial. The needle tip will be placed lateral to the superior trunk and 15 20 ml of 0.5% bupivacaine will be injected just inferior to the deep cervical fasica. Local circumferential spread will be achieved both anterior and posterior to the superior trunk.
intervention type: Drug
intervention name: Bupivacaine
description: Anesthetic that will help treat pain and sensation after shoulder arthroscopy
arm group label: interscalene block (ISB)
arm group label: superior trunk block (STB)
intervention type: Device
intervention name: Ultrasound
description: Ultrasound will help guide the anesthesiologist in performing the different nerve blocks
arm group label: interscalene block (ISB)
arm group label: superior trunk block (STB)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: David H Kim, MD
role: Principal Investigator
affiliation: Hospital for Special Surgery, New York
facility: 
country: United States
responsible party type: Sponsor
mesh term: Joint Diseases
mesh term: Acute Pain
mesh term: Chronic Pain
mesh term: Bupivacaine
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 