<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/NCT03827213</url>
  </required_header>
  <id_info>
    <org_study_id>2018-9707</org_study_id>
    <nct_id>NCT03827213</nct_id>
  </id_info>
  <brief_title>Exparel Interscalene vs Indwelling Catheter</brief_title>
  <official_title>Prospective Randomized Control Trial Evaluating Single Shot Exparel Versus Indwelling Interscalene Catheter for Total Shoulder Replacements- A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Montefiore Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Montefiore Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators are comparing an indwelling catheter with intermediate duration local&#xD;
      anesthetic to a single shot peripheral nerve block with long acting a local anesthetic&#xD;
      (Exparel).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      While placing an indwelling nerve catheter can prolong pain control, it can also have&#xD;
      drawbacks and complications. While major complications like pneumothorax and&#xD;
      hemidiaphragmatic paresis from interscalene continuous peripheral nerve blocks (CPNB) are&#xD;
      rare, minor adverse effects associated with CPNBs may be more common. They include infection&#xD;
      and anatomical damage to blood vessels and nerves due to the indwelling catheter. In&#xD;
      addition, catheters take a significantly longer time to set up and place than single shot&#xD;
      blocks, which is important as there is often a rush to block patients and trying to get them&#xD;
      into the operating room on time. Furthermore, the needle used for catheter placement is&#xD;
      larger than the single shot needles, which creates more discomfort to patients during the&#xD;
      nerve block. The catheter itself is taped around the entire sides and back of the patient's&#xD;
      neck, which is also uncomfortable for patients. Because of how shallow the interscalene block&#xD;
      is, the catheter is often found to be dislodged from operating room positioning, patient&#xD;
      transport or movement, which negates the placement of the catheter. An indwelling catheter&#xD;
      must also be followed up by the acute pain service team until the catheter is removed.&#xD;
&#xD;
      Exparel, or liposomal bupivacaine, is formulated to release low dose bupivacaine over 96&#xD;
      hours, and was recently approved by the FDA in April 2018 to be used in interscalene blocks.&#xD;
      The sustained release of local anesthetic could theoretically act similarly to the continuous&#xD;
      infusion of local anesthetic through an indwelling interscalene catheter, and could thus&#xD;
      avoid the need for placement of a catheter. Current existing data, although inconclusive, has&#xD;
      in some studies shown an equal analgesic effect as catheters. As per pharmacy, the cost of&#xD;
      the On-Q pump and the local anesthesia needed for the pump together cost $390 for each&#xD;
      indwelling catheter placed, not including the cost of anesthesia and pharmacy supplies and&#xD;
      labor. The cost of each 20 mL vial of Exparel is less at $285 and, for a single shot nerve&#xD;
      block, would avoid the extra costs and time needed for a catheter placement.&#xD;
&#xD;
      The investigators would like to perform a prospective randomized controlled pilot study to&#xD;
      examine the efficacy of single shot interscalene blocks using Exparel versus the traditional&#xD;
      interscalene catheter used at our institution. The purpose of the study the investigators are&#xD;
      proposing is to determine if single shot interscalene nerve blocks using Exparel can provide&#xD;
      equivalent or better analgesia than indwelling interscalene catheter in patients who undergo&#xD;
      total shoulder replacement surgery. If so, single shot interscalene nerve blocks with Exparel&#xD;
      may serve as a quicker, easier, cheaper, safer, and more comfortable alternative to placing&#xD;
      indwelling interscalene catheters.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Ran out of medication&#xD;
  </why_stopped>
  <start_date type="Actual">January 22, 2019</start_date>
  <completion_date type="Actual">June 1, 2021</completion_date>
  <primary_completion_date type="Actual">June 1, 2021</primary_completion_date>
  <phase>Phase 2</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>Opioid Requirements Assessed at 24 Hours Post-surgery</measure>
    <time_frame>24 Hours post-surgery</time_frame>
    <description>Participant opioid requirements at 24 hours from treatment in morphine equivalents. Will report how much pain management medication participant needed within first 24 hours post-surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intra-Operative Opioid Requirements</measure>
    <time_frame>Duration of Surgery (Approximately 3 hours)</time_frame>
    <description>Opioid requirements (morphine equivalents) during surgery. Will report how much pain management medication participant needed during surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid Requirements Assessed at 8-hours Post-surgery</measure>
    <time_frame>8 hour post-surgery</time_frame>
    <description>8-hour Opioid requirements (morphine equivalents). Will report how much pain management medication participant needed within first 8 hours after surgery.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Score in Post Anesthesia Care Unit (PACU)</measure>
    <time_frame>During time in PACU (up to 5 hours)</time_frame>
    <description>Collecting patient pain scores in the Post Anesthesia Care Unit (PACU). Participant will be asked to rate their pain score from 0 (no pain) to10 (worst pain)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Opioid Requirements Assessed at 48 Hours Post-surgery</measure>
    <time_frame>48 hours post-surgery</time_frame>
    <description>48 hour Opioid requirements (morphine equivalents). Will report how much pain management medication participant needed within first 48 hours after surgery.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Length of Stay</measure>
    <time_frame>At Discharge (up to 3 days)</time_frame>
    <description>Number of days subjects stayed until discharge. Will report how many days participant stayed in hospital after surgery.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">23</enrollment>
  <condition>Pain</condition>
  <arm_group>
    <arm_group_label>Single shot Interscalene Nerve Block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>This group will receive an interscalene nerve block. This will be administered as a single 20mL injection consisting of a mixture of 10mL of Exparel and 10mL of 0.5% bupivacaine hydrochloride.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Indwelling Interscalene Catheter</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will receive an indwelling interscalene catheter placed posterior to C5-C6 nerve roots (between the shoulders) and administered 15 mL of 0.5% ropivacaine plain for the block with no superficial cervical block. The &quot;On-Q&quot; pump will be set at a rate of 4 mL/hr.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Exparel</intervention_name>
    <description>A shot of long acting local anesthetic for post operative pain management</description>
    <arm_group_label>Single shot Interscalene Nerve Block</arm_group_label>
    <other_name>liposomal bupivacaine</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Indwelling Interscalene Catheter</intervention_name>
    <description>ropivacaine, given through a catheter inserted between the shoulders</description>
    <arm_group_label>Indwelling Interscalene Catheter</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesia (ASA) 1, 2, and 3&#xD;
&#xD;
          -  Ages 40-74&#xD;
&#xD;
          -  Patients scheduled for total shoulder replacement&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  ASA 4 and 5&#xD;
&#xD;
          -  Pre-existing pain disorder&#xD;
&#xD;
          -  Regular consumption of chronic pain medication&#xD;
&#xD;
          -  pregnant women&#xD;
&#xD;
          -  any medical condition such as a clotting disorder&#xD;
&#xD;
          -  anatomic abnormality that precludes use of an indwelling scalene catheter&#xD;
&#xD;
          -  Body Mass Index (BMI) &gt;40&#xD;
&#xD;
          -  Patient refusal&#xD;
&#xD;
          -  Pre-existing diabetic neuropathy or Hemoglobin A1c &gt;9&#xD;
&#xD;
          -  Failed block&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>74 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elilary Montilla Medrano, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Montefiore Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Borgeat A, Ekatodramis G. Anaesthesia for shoulder surgery. Best Pract Res Clin Anaesthesiol. 2002 Jun;16(2):211-25. doi: 10.1053/bean.2002.0234.</citation>
    <PMID>12491553</PMID>
  </reference>
  <reference>
    <citation>Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain--United States, 2016. JAMA. 2016 Apr 19;315(15):1624-45. doi: 10.1001/jama.2016.1464.</citation>
    <PMID>26977696</PMID>
  </reference>
  <reference>
    <citation>Wiegel M, Gottschaldt U, Hennebach R, Hirschberg T, Reske A. Complications and adverse effects associated with continuous peripheral nerve blocks in orthopedic patients. Anesth Analg. 2007 Jun;104(6):1578-82, table of contents. doi: 10.1213/01.ane.0000261260.69083.f3.</citation>
    <PMID>17513661</PMID>
  </reference>
  <reference>
    <citation>Sabesan VJ, Shahriar R, Petersen-Fitts GR, Whaley JD, Bou-Akl T, Sweet M, Milia M. A prospective randomized controlled trial to identify the optimal postoperative pain management in shoulder arthroplasty: liposomal bupivacaine versus continuous interscalene catheter. J Shoulder Elbow Surg. 2017 Oct;26(10):1810-1817. doi: 10.1016/j.jse.2017.06.044. Epub 2017 Aug 24.</citation>
    <PMID>28844420</PMID>
  </reference>
  <reference>
    <citation>Ilfeld BM, Viscusi ER, Hadzic A, Minkowitz HS, Morren MD, Lookabaugh J, Joshi GP. Safety and Side Effect Profile of Liposome Bupivacaine (Exparel) in Peripheral Nerve Blocks. Reg Anesth Pain Med. 2015 Sep-Oct;40(5):572-82. doi: 10.1097/AAP.0000000000000283.</citation>
    <PMID>26204387</PMID>
  </reference>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 31, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <results_first_submitted>January 4, 2023</results_first_submitted>
  <results_first_submitted_qc>February 12, 2023</results_first_submitted_qc>
  <results_first_posted type="Actual">March 7, 2023</results_first_posted>
  <last_update_submitted>February 12, 2023</last_update_submitted>
  <last_update_submitted_qc>February 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Montefiore Medical Center</investigator_affiliation>
    <investigator_full_name>Elilary Montilla Medrano</investigator_full_name>
    <investigator_title>Assistant Professor of Anesthesiology</investigator_title>
  </responsible_party>
  <keyword>shoulder surgery, post operative pain</keyword>
  <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>April 9, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/13/NCT03827213/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Single Shot Interscalene Nerve Block</title>
          <description>This group received an interscalene nerve block. This was administered as a single 20mL injection consisting of a mixture of 10mL of Exparel and 10mL of 0.5% bupivacaine hydrochloride.</description>
        </group>
        <group group_id="P2">
          <title>Indwelling Interscalene Catheter</title>
          <description>This group received an indwelling interscalene catheter placed posterior to C5-C6 nerve roots (between the shoulders) and administered 15 mL of 0.5% ropivacaine plain for the block with no superficial cervical block. The &quot;On-Q&quot; pump was set at a rate of 4 mL/hr.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="11"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="7"/>
                <participants group_id="P2" count="11"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Single Shot Interscalene Nerve Block</title>
          <description>This group received an interscalene nerve block. This was administered as a single 20mL injection consisting of a mixture of 10mL of Exparel and 10mL of 0.5% bupivacaine hydrochloride.</description>
        </group>
        <group group_id="B2">
          <title>Indwelling Interscalene Catheter</title>
          <description>This group received an indwelling interscalene catheter placed posterior to C5-C6 nerve roots (between the shoulders) and administered 15 mL of 0.5% ropivacaine plain for the block with no superficial cervical block. The &quot;On-Q&quot; pump was set at a rate of 4 mL/hr.</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="11"/>
            <count group_id="B2" value="12"/>
            <count group_id="B3" value="23"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="12"/>
                    <count group_id="B3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <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_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="16"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="12"/>
                    <count group_id="B3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="12"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </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>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="11"/>
                    <count group_id="B2" value="12"/>
                    <count group_id="B3" value="23"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Opioid Requirements Assessed at 24 Hours Post-surgery</title>
        <description>Participant opioid requirements at 24 hours from treatment in morphine equivalents. Will report how much pain management medication participant needed within first 24 hours post-surgery.</description>
        <time_frame>24 Hours post-surgery</time_frame>
        <population>Data were not collected/aggregated and, as such, no data was available for analysis of Outcome Measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Single Shot Interscalene Nerve Block</title>
            <description>This group received an interscalene nerve block. This was administered as a single 20mL injection consisting of a mixture of 10mL of Exparel and 10mL of 0.5% bupivacaine hydrochloride.</description>
          </group>
          <group group_id="O2">
            <title>Indwelling Interscalene Catheter</title>
            <description>This group received an indwelling interscalene catheter placed posterior to C5-C6 nerve roots (between the shoulders) and administered 15 mL of 0.5% ropivacaine plain for the block with no superficial cervical block. The &quot;On-Q&quot; pump was set at a rate of 4 mL/hr.</description>
          </group>
        </group_list>
        <measure>
          <title>Opioid Requirements Assessed at 24 Hours Post-surgery</title>
          <description>Participant opioid requirements at 24 hours from treatment in morphine equivalents. Will report how much pain management medication participant needed within first 24 hours post-surgery.</description>
          <population>Data were not collected/aggregated and, as such, no data was available for analysis of Outcome Measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Intra-Operative Opioid Requirements</title>
        <description>Opioid requirements (morphine equivalents) during surgery. Will report how much pain management medication participant needed during surgery.</description>
        <time_frame>Duration of Surgery (Approximately 3 hours)</time_frame>
        <population>Data were not collected/aggregated and, as such, no data was available for analysis of Outcome Measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Single Shot Interscalene Nerve Block</title>
            <description>This group received an interscalene nerve block. This was administered as a single 20mL injection consisting of a mixture of 10mL of Exparel and 10mL of 0.5% bupivacaine hydrochloride.</description>
          </group>
          <group group_id="O2">
            <title>Indwelling Interscalene Catheter</title>
            <description>This group received an indwelling interscalene catheter placed posterior to C5-C6 nerve roots (between the shoulders) and administered 15 mL of 0.5% ropivacaine plain for the block with no superficial cervical block. The &quot;On-Q&quot; pump was set at a rate of 4 mL/hr.</description>
          </group>
        </group_list>
        <measure>
          <title>Intra-Operative Opioid Requirements</title>
          <description>Opioid requirements (morphine equivalents) during surgery. Will report how much pain management medication participant needed during surgery.</description>
          <population>Data were not collected/aggregated and, as such, no data was available for analysis of Outcome Measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Opioid Requirements Assessed at 8-hours Post-surgery</title>
        <description>8-hour Opioid requirements (morphine equivalents). Will report how much pain management medication participant needed within first 8 hours after surgery.</description>
        <time_frame>8 hour post-surgery</time_frame>
        <population>Data were not collected/aggregated and, as such, no data was available for analysis of Outcome Measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Single Shot Interscalene Nerve Block</title>
            <description>This group received an interscalene nerve block. This was administered as a single 20mL injection consisting of a mixture of 10mL of Exparel and 10mL of 0.5% bupivacaine hydrochloride.</description>
          </group>
          <group group_id="O2">
            <title>Indwelling Interscalene Catheter</title>
            <description>This group received an indwelling interscalene catheter placed posterior to C5-C6 nerve roots (between the shoulders) and administered 15 mL of 0.5% ropivacaine plain for the block with no superficial cervical block. The &quot;On-Q&quot; pump was set at a rate of 4 mL/hr.</description>
          </group>
        </group_list>
        <measure>
          <title>Opioid Requirements Assessed at 8-hours Post-surgery</title>
          <description>8-hour Opioid requirements (morphine equivalents). Will report how much pain management medication participant needed within first 8 hours after surgery.</description>
          <population>Data were not collected/aggregated and, as such, no data was available for analysis of Outcome Measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Score in Post Anesthesia Care Unit (PACU)</title>
        <description>Collecting patient pain scores in the Post Anesthesia Care Unit (PACU). Participant will be asked to rate their pain score from 0 (no pain) to10 (worst pain)</description>
        <time_frame>During time in PACU (up to 5 hours)</time_frame>
        <population>Data were not collected/aggregated and, as such, no data was available for analysis of Outcome Measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Single Shot Interscalene Nerve Block</title>
            <description>This group received an interscalene nerve block. This was administered as a single 20mL injection consisting of a mixture of 10mL of Exparel and 10mL of 0.5% bupivacaine hydrochloride.</description>
          </group>
          <group group_id="O2">
            <title>Indwelling Interscalene Catheter</title>
            <description>This group received an indwelling interscalene catheter placed posterior to C5-C6 nerve roots (between the shoulders) and administered 15 mL of 0.5% ropivacaine plain for the block with no superficial cervical block. The &quot;On-Q&quot; pump was set at a rate of 4 mL/hr.</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Score in Post Anesthesia Care Unit (PACU)</title>
          <description>Collecting patient pain scores in the Post Anesthesia Care Unit (PACU). Participant will be asked to rate their pain score from 0 (no pain) to10 (worst pain)</description>
          <population>Data were not collected/aggregated and, as such, no data was available for analysis of Outcome Measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Opioid Requirements Assessed at 48 Hours Post-surgery</title>
        <description>48 hour Opioid requirements (morphine equivalents). Will report how much pain management medication participant needed within first 48 hours after surgery.</description>
        <time_frame>48 hours post-surgery</time_frame>
        <population>Data were not collected/aggregated and, as such, no data was available for analysis of Outcome Measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Single Shot Interscalene Nerve Block</title>
            <description>This group received an interscalene nerve block. This was administered as a single 20mL injection consisting of a mixture of 10mL of Exparel and 10mL of 0.5% bupivacaine hydrochloride.</description>
          </group>
          <group group_id="O2">
            <title>Indwelling Interscalene Catheter</title>
            <description>This group received an indwelling interscalene catheter placed posterior to C5-C6 nerve roots (between the shoulders) and administered 15 mL of 0.5% ropivacaine plain for the block with no superficial cervical block. The &quot;On-Q&quot; pump was set at a rate of 4 mL/hr.</description>
          </group>
        </group_list>
        <measure>
          <title>Opioid Requirements Assessed at 48 Hours Post-surgery</title>
          <description>48 hour Opioid requirements (morphine equivalents). Will report how much pain management medication participant needed within first 48 hours after surgery.</description>
          <population>Data were not collected/aggregated and, as such, no data was available for analysis of Outcome Measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Length of Stay</title>
        <description>Number of days subjects stayed until discharge. Will report how many days participant stayed in hospital after surgery.</description>
        <time_frame>At Discharge (up to 3 days)</time_frame>
        <population>Data were not collected/aggregated and, as such, no data was available for analysis of Outcome Measure.</population>
        <group_list>
          <group group_id="O1">
            <title>Single Shot Interscalene Nerve Block</title>
            <description>This group received an interscalene nerve block. This was administered as a single 20mL injection consisting of a mixture of 10mL of Exparel and 10mL of 0.5% bupivacaine hydrochloride.</description>
          </group>
          <group group_id="O2">
            <title>Indwelling Interscalene Catheter</title>
            <description>This group received an indwelling interscalene catheter placed posterior to C5-C6 nerve roots (between the shoulders) and administered 15 mL of 0.5% ropivacaine plain for the block with no superficial cervical block. The &quot;On-Q&quot; pump was set at a rate of 4 mL/hr.</description>
          </group>
        </group_list>
        <measure>
          <title>Length of Stay</title>
          <description>Number of days subjects stayed until discharge. Will report how many days participant stayed in hospital after surgery.</description>
          <population>Data were not collected/aggregated and, as such, no data was available for analysis of Outcome Measure.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Up to 72 hours</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Single Shot Interscalene Nerve Block</title>
          <description>This group received an interscalene nerve block. This was administered as a single 20mL injection consisting of a mixture of 10mL of Exparel and 10mL of 0.5% bupivacaine hydrochloride.</description>
        </group>
        <group group_id="E2">
          <title>Indwelling Interscalene Catheter</title>
          <description>This group received an indwelling interscalene catheter placed posterior to C5-C6 nerve roots (between the shoulders) and administered 15 mL of 0.5% ropivacaine plain for the block with no superficial cervical block. The &quot;On-Q&quot; pump was set at a rate of 4 mL/hr.</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="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA (Unspecified)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina</sub_title>
                <description>Chest Pain</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Postoperative Respiratory Complications</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="11"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="12"/>
              </event>
              <event>
                <sub_title>Dyspnea</sub_title>
                <description>Shortness of Breath</description>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="11"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="12"/>
              </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>Elilary Medilla Medrano</name_or_title>
      <organization>Montefiore Medical Center</organization>
      <phone>(718) 920-4316</phone>
      <email>emontill@montefiore.org</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/NCT03827213
org study id: 2018-9707
nct id: NCT03827213
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The investigators are comparing an indwelling catheter with intermediate duration local
      anesthetic to a single shot peripheral nerve block with long acting a local anesthetic
      (Exparel).
While placing an indwelling nerve catheter can prolong pain control, it can also have
      drawbacks and complications. While major complications like pneumothorax and
      hemidiaphragmatic paresis from interscalene continuous peripheral nerve blocks (CPNB) are
      rare, minor adverse effects associated with CPNBs may be more common. They include infection
      and anatomical damage to blood vessels and nerves due to the indwelling catheter. In
      addition, catheters take a significantly longer time to set up and place than single shot
      blocks, which is important as there is often a rush to block patients and trying to get them
      into the operating room on time. Furthermore, the needle used for catheter placement is
      larger than the single shot needles, which creates more discomfort to patients during the
      nerve block. The catheter itself is taped around the entire sides and back of the patient's
      neck, which is also uncomfortable for patients. Because of how shallow the interscalene block
      is, the catheter is often found to be dislodged from operating room positioning, patient
      transport or movement, which negates the placement of the catheter. An indwelling catheter
      must also be followed up by the acute pain service team until the catheter is removed.

      Exparel, or liposomal bupivacaine, is formulated to release low dose bupivacaine over 96
      hours, and was recently approved by the FDA in April 2018 to be used in interscalene blocks.
      The sustained release of local anesthetic could theoretically act similarly to the continuous
      infusion of local anesthetic through an indwelling interscalene catheter, and could thus
      avoid the need for placement of a catheter. Current existing data, although inconclusive, has
      in some studies shown an equal analgesic effect as catheters. As per pharmacy, the cost of
      the On-Q pump and the local anesthesia needed for the pump together cost $390 for each
      indwelling catheter placed, not including the cost of anesthesia and pharmacy supplies and
      labor. The cost of each 20 mL vial of Exparel is less at $285 and, for a single shot nerve
      block, would avoid the extra costs and time needed for a catheter placement.

      The investigators would like to perform a prospective randomized controlled pilot study to
      examine the efficacy of single shot interscalene blocks using Exparel versus the traditional
      interscalene catheter used at our institution. The purpose of the study the investigators are
      proposing is to determine if single shot interscalene nerve blocks using Exparel can provide
      equivalent or better analgesia than indwelling interscalene catheter in patients who undergo
      total shoulder replacement surgery. If so, single shot interscalene nerve blocks with Exparel
      may serve as a quicker, easier, cheaper, safer, and more comfortable alternative to placing
      indwelling interscalene catheters.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Opioid Requirements Assessed at 24 Hours Post-surgery
time frame: 24 Hours post-surgery
description: Participant opioid requirements at 24 hours from treatment in morphine equivalents. Will report how much pain management medication participant needed within first 24 hours post-surgery.
measure: Intra-Operative Opioid Requirements
time frame: Duration of Surgery (Approximately 3 hours)
description: Opioid requirements (morphine equivalents) during surgery. Will report how much pain management medication participant needed during surgery.
measure: Opioid Requirements Assessed at 8-hours Post-surgery
time frame: 8 hour post-surgery
description: 8-hour Opioid requirements (morphine equivalents). Will report how much pain management medication participant needed within first 8 hours after surgery.
measure: Pain Score in Post Anesthesia Care Unit (PACU)
time frame: During time in PACU (up to 5 hours)
description: Collecting patient pain scores in the Post Anesthesia Care Unit (PACU). Participant will be asked to rate their pain score from 0 (no pain) to10 (worst pain)
measure: Opioid Requirements Assessed at 48 Hours Post-surgery
time frame: 48 hours post-surgery
description: 48 hour Opioid requirements (morphine equivalents). Will report how much pain management medication participant needed within first 48 hours after surgery.
measure: Length of Stay
time frame: At Discharge (up to 3 days)
description: Number of days subjects stayed until discharge. Will report how many days participant stayed in hospital after surgery.
arm group label: Single shot Interscalene Nerve Block
arm group type: Experimental
description: This group will receive an interscalene nerve block. This will be administered as a single 20mL injection consisting of a mixture of 10mL of Exparel and 10mL of 0.5% bupivacaine hydrochloride.
arm group label: Indwelling Interscalene Catheter
arm group type: Active Comparator
description: This group will receive an indwelling interscalene catheter placed posterior to C5-C6 nerve roots (between the shoulders) and administered 15 mL of 0.5% ropivacaine plain for the block with no superficial cervical block. The "On-Q" pump will be set at a rate of 4 mL/hr.
intervention type: Drug
intervention name: Exparel
description: A shot of long acting local anesthetic for post operative pain management
arm group label: Single shot Interscalene Nerve Block
other name: liposomal bupivacaine
intervention type: Device
intervention name: Indwelling Interscalene Catheter
description: ropivacaine, given through a catheter inserted between the shoulders
arm group label: Indwelling Interscalene Catheter
criteria: 
gender: All
minimum age: 40 Years
maximum age: 74 Years
healthy volunteers: No
last name: Elilary Montilla Medrano, MD
role: Principal Investigator
affiliation: Montefiore Medical Center
facility: 
country: United States
citation: Borgeat A, Ekatodramis G. Anaesthesia for shoulder surgery. Best Pract Res Clin Anaesthesiol. 2002 Jun;16(2):211-25. doi: 10.1053/bean.2002.0234.
PMID: 12491553
citation: Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain--United States, 2016. JAMA. 2016 Apr 19;315(15):1624-45. doi: 10.1001/jama.2016.1464.
PMID: 26977696
citation: Wiegel M, Gottschaldt U, Hennebach R, Hirschberg T, Reske A. Complications and adverse effects associated with continuous peripheral nerve blocks in orthopedic patients. Anesth Analg. 2007 Jun;104(6):1578-82, table of contents. doi: 10.1213/01.ane.0000261260.69083.f3.
PMID: 17513661
citation: Sabesan VJ, Shahriar R, Petersen-Fitts GR, Whaley JD, Bou-Akl T, Sweet M, Milia M. A prospective randomized controlled trial to identify the optimal postoperative pain management in shoulder arthroplasty: liposomal bupivacaine versus continuous interscalene catheter. J Shoulder Elbow Surg. 2017 Oct;26(10):1810-1817. doi: 10.1016/j.jse.2017.06.044. Epub 2017 Aug 24.
PMID: 28844420
citation: Ilfeld BM, Viscusi ER, Hadzic A, Minkowitz HS, Morren MD, Lookabaugh J, Joshi GP. Safety and Side Effect Profile of Liposome Bupivacaine (Exparel) in Peripheral Nerve Blocks. Reg Anesth Pain Med. 2015 Sep-Oct;40(5):572-82. doi: 10.1097/AAP.0000000000000283.
PMID: 26204387
responsible party type: Principal Investigator
investigator affiliation: Montefiore Medical Center
investigator full name: Elilary Montilla Medrano
investigator title: Assistant Professor of Anesthesiology
mesh term: Bupivacaine
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 