<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/NCT03822182</url>
  </required_header>
  <id_info>
    <org_study_id>1806933448</org_study_id>
    <nct_id>NCT03822182</nct_id>
  </id_info>
  <brief_title>Single Shot Liposomal Bupivicaine in Rotator Cuff Surgery</brief_title>
  <official_title>A Prospective Randomized Controlled Trial Examining the Effectiveness of a Single Shot of Liposomal Bupivicaine for Reducing Post-operative Pain and Narcotic Use in Outpatient Rotator Cuff Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indiana University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Indiana University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This document is a protocol for a human research study. This study is to be conducted&#xD;
      according to United States standards of Good Clinical Practice in accordance with applicable&#xD;
      Federal regulations and institutional research policies and procedures.&#xD;
&#xD;
      Liposomal bupivacaine (LB) has been shown to decrease post-operative pain and narcotic use&#xD;
      when administered perioperatively as a local injection during arthroplasty procedures.&#xD;
      Studies have also demonstrated that LB used in conjunction with dexamethasone may increase&#xD;
      the duration of effectiveness of LB. This study seeks to evaluate if there is a difference in&#xD;
      post-operative pain and narcotic use when LB is administered in an interscalene block during&#xD;
      outpatient rotator cuff repair surgery. Furthermore, this study aims to determine if the&#xD;
      addition of dexamethasone with LB results in a prolonged decrease in post-operative pain and&#xD;
      a reduction in narcotic use.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Outpatient surgery has become the gold standard for arthroscopic rotator cuff repair.&#xD;
      Innovations in pain management with regional anesthesia and multimodal techniques have&#xD;
      greatly contributed to this transition over the past several decades. Despite overall&#xD;
      improvements, uncontrolled postoperative pain leads to prolonged ambulatory stays, increased&#xD;
      patient dissatisfaction, unexpected admissions to the hospital or visits to the Emergency&#xD;
      Room after surgery, and a greater incidence of complications. Furthermore, in the wake of the&#xD;
      &quot;opioid epidemic&quot;, concerns with narcotic consumption and addiction have become heightened&#xD;
      with regulations and laws recently enacted making prescribing and managing postoperative pain&#xD;
      ever more difficult.&#xD;
&#xD;
      Interscalene nerve blockade for shoulder procedures has become an increasingly common&#xD;
      technique to provide perioperative pain control with good efficacy, low complication rates&#xD;
      and reduced narcotic consumption. While the utilization of ultrasound to help administer the&#xD;
      block has aided in the accuracy providing a more consistent analgesic effect, its overall&#xD;
      short duration (12-24 hours) remains one of the major limitations of this technique.&#xD;
      Modalities to prolong its effect have included use of indwelling catheters and the addition&#xD;
      of perineural dexamethasone.&#xD;
&#xD;
      Recently, liposomal bupivacaine (LB) (Exparel) was approved for single shot interscalene&#xD;
      administration by the FDA. This medication has been purported to provide up to 72 hours of&#xD;
      extended release of bupivacaine via its multivesicular and honeycomb-like structure that&#xD;
      predictably breaks down resulting in a slow and sustained release of the medication.9&#xD;
      Although numerous studies have been conducted and several meta-analyses performed looking at&#xD;
      the overall efficacy of local injections of LB for operative procedures in an inpatient&#xD;
      setting, no study to date has independently assessed its efficacy in the new perineural&#xD;
      indication for outpatient shoulder surgery. Furthermore, no study to date has compared the&#xD;
      use of LB to the use of LB with dexamethasone in a perineural indication to see if the&#xD;
      duration of efficacy is further prolonged with the addition of dexamethasone. All existing&#xD;
      literature is in regard to use of liposomal bupivacaine injected locally within the surgical&#xD;
      site. This will be the first study to examine the perineural use of LB for outpatient&#xD;
      shoulder surgery, and to determine if there is a prolonged decrease in pain and a decrease in&#xD;
      narcotic consumption with the use of LB with dexamethasone when delivered as an interscalene&#xD;
      block in an ambulatory setting.&#xD;
&#xD;
      Utilizing a prospective randomized controlled trial, this study seeks to evaluate if there is&#xD;
      a difference in post-operative pain and narcotic use when LB is administered in an&#xD;
      interscalene block during outpatient rotator cuff repair surgery. Furthermore, this study&#xD;
      aims to determine if the addition of dexamethasone with LB results in a prolonged decrease in&#xD;
      post-operative pain and an overall reduction in narcotic use.&#xD;
&#xD;
      Primary Aims &amp; Objective&#xD;
&#xD;
      Aim 1a: To determine if the use of LB in an interscalene block decreases patient-reported&#xD;
      post-operative visual analogue pain scale (VAS) in patients undergoing outpatient rotator&#xD;
      cuff surgery&#xD;
&#xD;
      Hypothesis: There will be a decrease in the visual analogue pain scale for up to 72 hours&#xD;
      post-operatively among participants who receive LB or LB plus dexamethasone, as compared to&#xD;
      the control group (bupivacaine plus dexamethasone).&#xD;
&#xD;
      Objective: Utilizing a prospective randomized controlled trial, post-operative&#xD;
      patient-reported VAS pain (on a scale of 1-10) will be collected 3 times per day (every 8&#xD;
      hours) for 5 post-operative days (PODs), corresponding to a total of 120 hours after surgery.&#xD;
      For each 24-hour period (corresponding to each POD), the pain scores will be averaged and&#xD;
      compared between the three treatment groups (control, LB, and LB plus dexamethasone) for each&#xD;
      of the 5 PODs.&#xD;
&#xD;
      Aim 1b: To determine if the use of LB plus dexamethasone in an interscalene block decreases&#xD;
      patient-reported post-operative VAS pain for a longer duration than the LB or the control&#xD;
      group (bupivacaine plus dexamethasone) in patients undergoing outpatient rotator cuff surgery&#xD;
&#xD;
      Hypothesis: There will be a decrease in visual analogue pain scale for greater than 72 hours&#xD;
      post-operatively among participants who receive LB plus dexamethasone, as compared to the LB&#xD;
      and the control group (bupivacaine plus dexamethasone).&#xD;
&#xD;
      Objective: Utilizing a prospective randomized controlled trial, post-operative&#xD;
      patient-reported visual analogue pain scale (on a scale of 1-10) will be collected 3 times&#xD;
      per day (every 8 hours) for 5 post-operative days (PODs), corresponding to a total of 120&#xD;
      hours after surgery. For each 24-hour period (corresponding to each POD), the pain scores&#xD;
      will be averaged and compared between the three treatment groups (control, LB, and LB plus&#xD;
      dexamethasone) for each of the 5 PODs.&#xD;
&#xD;
      Secondary Aims &amp; Objectives&#xD;
&#xD;
      Aim 2a: To determine if there is a difference in time at which post-operative narcotics are&#xD;
      first used among three groups receiving different interscalene blocks (LB plus dexamethasone,&#xD;
      LB, and control) in patients undergoing outpatient rotator cuff surgery.&#xD;
&#xD;
      Hypothesis: Narcotic use will begin at a later time among those receiving LB plus&#xD;
      dexamethasone, as compared to the LB and the control group (bupivacaine plus dexamethasone).&#xD;
&#xD;
      Objective: Utilizing a prospective randomized controlled trial, narcotic use will be&#xD;
      collected at 8-hour increments for a total of 5 post-operative days (PODs), corresponding to&#xD;
      a period of 120 hours post-surgery. The 8-hour time period during which a participant first&#xD;
      begins using a narcotic will be recorded and compared between three treatment groups&#xD;
      (control, LB, and LB plus dexamethasone).&#xD;
&#xD;
      Aim 2b: To determine if there is a difference in patient-reported post-operative narcotic use&#xD;
      (measured in morphine equivalents) among three groups receiving different interscalene blocks&#xD;
      (LB plus dexamethasone, LB, and control) in patients undergoing outpatient rotator cuff&#xD;
      surgery.&#xD;
&#xD;
      Hypothesis: There will be a decrease in cumulative narcotic use (measured in morphine&#xD;
      equivalents) among participants who receive LB plus dexamethasone, as compared to the LB and&#xD;
      the control group (bupivacaine plus dexamethasone).&#xD;
&#xD;
      Objective: Utilizing a prospective randomized controlled trial, post-operative&#xD;
      patient-reported narcotic use (measured by the number of tablets ingested and converted to&#xD;
      morphine equivalents) will be collected 3 times per day at 8-hour increments for a total of 5&#xD;
      post-operative days (PODs), corresponding to a total of 120 hours after surgery. For each&#xD;
      24-hour period (corresponding to each POD), narcotic use will be tabulated and compared&#xD;
      between three treatment groups (control, LB, and LB plus dexamethasone). Furthermore,&#xD;
      cumulative narcotic use during the 5-day (120 hour) study period will be calculated and&#xD;
      compared between three treatment groups (control, LB, and LB plus dexamethasone).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 24, 2018</start_date>
  <completion_date type="Actual">January 22, 2020</completion_date>
  <primary_completion_date type="Actual">January 22, 2020</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>
    <intervention_model_description>The medication administered in the interscalene block is the intervention in this study. There are three different types of interscalene blocks that will be administered in order to compare the independent effectiveness of LB with the effectiveness of LB plus dexamethasone. Study participants will be randomized into one of three groups. The treatment groups are listed below:&#xD;
Group 1 (Control) Group 2 Group 3 30 ml of 0.5% bupivacaine and 0.4ml. of dexamethasone 15ml 0.5% bupivacaine and 10ml of LB (Exparel) and 5.4ml normal saline 15ml 0.5% bupivacaine and 10ml LB (Exparel) and 0.4ml dexamethasone and 5ml normal saline</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
    <masking_description>This is a double-blinded study, thus, neither the surgeon nor the patient will know which type of interscalene block is used. A total of 78 envelopes containing will be generated consisting of 26 with Group 1&quot;, 26 with &quot;Group 2&quot; and 26 with &quot;Group 3&quot; designation. Envelopes will be sealed and randomly chosen by the anesthesiologist prior to surgery. The anesthesiologist will randomly select one of the envelopes which will determine the treatment group and indicate medications that will be included in the interscalene block. Patients will be blinded to the medication utilized as well as the treating surgeon.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Reported Postoperative Pain: VAS</measure>
    <time_frame>4 days post procedure</time_frame>
    <description>Patient-reported post-operative VAS pain (on a scale of 0-10 with zero implying no pain and 10 indicating severe pain), measured post operatively, in 8-hour increments, for a total of 96 hours post-surgery, Patients will be prompted via text message to provide VAS pain every 8 hours. If a response text message is not received, a phone call will be made to obtain the information. Patients who do not have a smart phone will receive a phone call or keep a personal log of VAS pain.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient Reported Post Operative Opioid Use</measure>
    <time_frame>4 days post procedure</time_frame>
    <description>Patient-reported post-operative opioid use (converted to morphine equivalents), collected post operatively, in 8-hour increments, for a total of 96 hours post-surgery Patients will be prompted via text message to provide the amount of narcotics (number of pills converted to morphine equivalents) taken over the course of the previous 8 hours. If a response text message is not received, a phone call will be made to obtain the information. Patients who do not have a smart phone will receive a phone call or keep a personal log of narcotic use.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">78</enrollment>
  <condition>Rotator Cuff Tear</condition>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>Control/Bupivicaine +DMSO</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Group 1 will serve as the control and receive the standard injection consisting 30 ml of 0.5% bupivacaine and 0.4ml (4 mg) of dexamethasone.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Liposomal bupivicaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group 2 will receive a block with 15ml 0.5% bupivacaine and 10ml (133mg) of liposomal bupivicaine (Exparel) and 5.4ml of Normal Saline</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Liposomal Bupivicaine +DMSO</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Group 3 will receive 15ml of 0.5% bupivicaine and 10ml (133mg) of Liposomal Bupivicaine (Exparel) and 0.4ml (4mg) dexamethasone and 5ml normal saline</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>liposomal bupivicaine</intervention_name>
    <description>The medication administered in the interscalene block is the intervention in this study. There are three different types of interscalene blocks that will be administered in order to compare the independent effectiveness of LB with the effectiveness of LB plus dexamethasone. Study participants will be randomized into one of three groups. The treatment groups are listed below:&#xD;
Group 1 (Control): 30 ml of 0.5% bupivacaine and 0.4ml (4 mg) of dexamethasone Group 2: 15ml 0.5% bupivacaine and 10ml (133mg) of LB (Exparel) and 5.4ml normal saline Group 3: 5ml 0.5% bupivacaine and 10ml LB (Exparel) and 0.4ml (4 mg) dexamethasone and 5ml normal saline</description>
    <arm_group_label>Liposomal Bupivicaine +DMSO</arm_group_label>
    <arm_group_label>Liposomal bupivicaine</arm_group_label>
    <other_name>Exparel</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Dexamethasone</intervention_name>
    <description>steroid that will be used in control as well as in group 3 to see if effect with liposomal bupivicaine is prolonged as has been shown with standard bupivicaine.</description>
    <arm_group_label>Control/Bupivicaine +DMSO</arm_group_label>
    <arm_group_label>Liposomal Bupivicaine +DMSO</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 and older&#xD;
&#xD;
          -  Primary diagnosis of rotator cuff tear&#xD;
&#xD;
          -  Able to provide informed consent&#xD;
&#xD;
          -  Is willing and able to accept text messages&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known allergies to the study medications.&#xD;
&#xD;
          -  Known narcotic or alcohol abuse (&lt; 3 months)&#xD;
&#xD;
          -  Revision rotator cuff surgery&#xD;
&#xD;
          -  Contraindication to regional anesthesia&#xD;
&#xD;
          -  Current narcotic regimen or contract with pain management specialist&#xD;
&#xD;
          -  Diagnosed with any of the following co-morbidities:&#xD;
&#xD;
               -  Pre-existing coagulation disorder&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>brian badman, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Indiana University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>American Health Network</name>
      <address>
        <city>Avon</city>
        <state>Indiana</state>
        <zip>46123</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Cao X, Pan F. Comparison of liposomal bupivacaine infiltration versus interscalene nerve block for pain control in total shoulder arthroplasty: A meta-analysis of randomized control trails. Medicine (Baltimore). 2017 Sep;96(39):e8079. doi: 10.1097/MD.0000000000008079.</citation>
    <PMID>28953626</PMID>
  </reference>
  <reference>
    <citation>Bramlett K, Onel E, Viscusi ER, Jones K. A randomized, double-blind, dose-ranging study comparing wound infiltration of DepoFoam bupivacaine, an extended-release liposomal bupivacaine, to bupivacaine HCl for postsurgical analgesia in total knee arthroplasty. Knee. 2012 Oct;19(5):530-6. doi: 10.1016/j.knee.2011.12.004. Epub 2012 Jan 28.</citation>
    <PMID>22285545</PMID>
  </reference>
  <reference>
    <citation>Surdam JW, Licini DJ, Baynes NT, Arce BR. The use of exparel (liposomal bupivacaine) to manage postoperative pain in unilateral total knee arthroplasty patients. J Arthroplasty. 2015 Feb;30(2):325-9. doi: 10.1016/j.arth.2014.09.004. Epub 2014 Sep 16.</citation>
    <PMID>25282071</PMID>
  </reference>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>January 27, 2019</study_first_submitted>
  <study_first_submitted_qc>January 29, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 30, 2019</study_first_posted>
  <results_first_submitted>April 28, 2020</results_first_submitted>
  <results_first_submitted_qc>August 29, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">September 1, 2020</results_first_posted>
  <last_update_submitted>November 9, 2020</last_update_submitted>
  <last_update_submitted_qc>November 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indiana University</investigator_affiliation>
    <investigator_full_name>Brian Badman</investigator_full_name>
    <investigator_title>Principal Investigator, Clinical Associate Professor, Department of Orthopedic Surgery</investigator_title>
  </responsible_party>
  <keyword>liposomal bupivicaine</keyword>
  <keyword>interscalene block</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
    <mesh_term>Rotator Cuff Injuries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dexamethasone</mesh_term>
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No plans to share</ipd_description>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>November 19, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT03822182/ICF_006.pdf</document_url>
    </provided_document>
    <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>November 19, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/82/NCT03822182/Prot_SAP_007.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Enrollment was between November 2018 and January 2020 and inclusive of all patients with a torn rotator cuff in the clinical practice of the PI</recruitment_details>
      <pre_assignment_details>A total of 78 patients were enrolled. 1 patient was excluded after inspect report showing current narcotic use. 1 patient was excluded for failure to submit data postoperatively.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Control/Bupivicaine+DMSO</title>
          <description>Group 1 will serve as the control and receive the standard injection consisting 30 ml of 0.5% bupivacaine and 0.4ml (4 mg) of dexamethasone.&#xD;
Dexamethasone: steroid that will be used in control as well as in group 3 to see if effect with liposomal bupivicaine is prolonged as has been shown with standard bupivicaine.</description>
        </group>
        <group group_id="P2">
          <title>Liposomal Bupivicaine</title>
          <description>Group 2 will receive a block with 15ml 0.5% bupivacaine and 10ml (133mg) of liposomal bupivicaine (Exparel) and 5.4ml of Normal Saline&#xD;
liposomal bupivicaine: The medication administered in the interscalene block is the intervention in this study.</description>
        </group>
        <group group_id="P3">
          <title>Liposomal Bupivicaine + DMSO</title>
          <description>Group 3 will receive 15ml of 0.5% bupivicaine and 10ml (133mg) of Liposomal Bupivicaine (Exparel) and 0.4ml (4mg) dexamethasone and 5ml normal saline&#xD;
liposomal bupivicaine: The medication administered in the interscalene block is the intervention in this study.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="25"/>
                <participants group_id="P3" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="26"/>
                <participants group_id="P2" count="24"/>
                <participants group_id="P3" count="26"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Protocol Violation</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Group 1 Control</title>
          <description>Group 1 will serve as the control and receive the standard injection consisting 30 ml of 0.5% bupivacaine and 0.4ml (4 mg) of dexamethasone.&#xD;
Dexamethasone: steroid that will be used in control as well as in group 3 to see if effect with liposomal bupivicaine is prolonged as has been shown with standard bupivicaine.</description>
        </group>
        <group group_id="B2">
          <title>Group 2</title>
          <description>Group 2 will receive a block with 15ml 0.5% bupivacaine and 10ml (133mg) of liposomal bupivicaine (Exparel) and 5.4ml of Normal Saline&#xD;
liposomal bupivicaine: The medication administered in the interscalene block is the intervention in this study. There are three different types of interscalene blocks that will be administered in order to compare the independent effectiveness of LB with the effectiveness of LB plus dexamethasone. Study participants will be randomized into one of three groups. The treatment groups are listed below:</description>
        </group>
        <group group_id="B3">
          <title>Group 3</title>
          <description>Group 3 will receive 15ml of 0.5% bupivicaine and 10ml (133mg) of Liposomal Bupivicaine (Exparel) and 0.4ml (4mg) dexamethasone and 5ml normal saline&#xD;
liposomal bupivicaine: The medication administered in the interscalene block is the intervention in this study. There are three different types of interscalene blocks that will be administered in order to compare the independent effectiveness of LB with the effectiveness of LB plus dexamethasone. Study participants will be randomized into one of three groups. The treatment groups are listed below:&#xD;
Dexamethasone: steroid that will be used in control as well as in group 3 to see if effect with liposomal bupivicaine is prolonged as has been shown with standard bupivicaine.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="26"/>
            <count group_id="B2" value="24"/>
            <count group_id="B3" value="26"/>
            <count group_id="B4" value="76"/>
          </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="26"/>
                    <count group_id="B2" value="24"/>
                    <count group_id="B3" value="26"/>
                    <count group_id="B4" value="76"/>
                  </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 group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="22"/>
                    <measurement group_id="B4" value="62"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="14"/>
                  </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="26"/>
                    <count group_id="B2" value="24"/>
                    <count group_id="B3" value="26"/>
                    <count group_id="B4" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="14"/>
                    <measurement group_id="B4" value="35"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="12"/>
                    <measurement group_id="B4" value="41"/>
                  </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 group_id="B4" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B4" 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="26"/>
                    <count group_id="B2" value="24"/>
                    <count group_id="B3" value="26"/>
                    <count group_id="B4" value="76"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="26"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="26"/>
                    <measurement group_id="B4" value="76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Patient Reported Postoperative Pain: VAS</title>
        <description>Patient-reported post-operative VAS pain (on a scale of 0-10 with zero implying no pain and 10 indicating severe pain), measured post operatively, in 8-hour increments, for a total of 96 hours post-surgery, Patients will be prompted via text message to provide VAS pain every 8 hours. If a response text message is not received, a phone call will be made to obtain the information. Patients who do not have a smart phone will receive a phone call or keep a personal log of VAS pain.</description>
        <time_frame>4 days post procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control/Bupivicaine+DMSO</title>
            <description>Group 1 will serve as the control and receive the standard injection consisting 30 ml of 0.5% bupivacaine and 0.4ml (4 mg) of dexamethasone.&#xD;
Dexamethasone: steroid that will be used in control as well as in group 3 to see if effect with liposomal bupivicaine is prolonged as has been shown with standard bupivicaine.</description>
          </group>
          <group group_id="O2">
            <title>Liposomal Bupivicaine</title>
            <description>Group 2 will receive a block with 15ml 0.5% bupivacaine and 10ml (133mg) of liposomal bupivicaine (Exparel) and 5.4ml of Normal Saline&#xD;
liposomal bupivicaine: The medication administered in the interscalene block is the intervention in this study. There are three different types of interscalene blocks that will be administered in order to compare the independent effectiveness of LB with the effectiveness of LB plus dexamethasone. Study participants will be randomized into one of three groups. The treatment groups are listed below:&#xD;
Group 1 (Control): 30 ml of 0.5% bupivacaine and 0.4ml (4 mg) of dexamethasone Group 2: 15ml 0.5% bupivacaine and 10ml (133mg) of LB (Exparel) and 5.4ml normal saline Group 3: 5ml 0.5% bupivacaine and 10ml LB (Exparel) and 0.4ml (4 mg) dexamethasone and 5ml normal saline</description>
          </group>
          <group group_id="O3">
            <title>Liposomal Bupivicaine + DMSO</title>
            <description>Group 3 will receive 15ml of 0.5% bupivicaine and 10ml (133mg) of Liposomal Bupivicaine (Exparel) and 0.4ml (4mg) dexamethasone and 5ml normal saline&#xD;
liposomal bupivicaine: The medication administered in the interscalene block is the intervention in this study. There are three different types of interscalene blocks that will be administered in order to compare the independent effectiveness of LB with the effectiveness of LB plus dexamethasone. Study participants will be randomized into one of three groups. The treatment groups are listed below:&#xD;
Group 1 (Control): 30 ml of 0.5% bupivacaine and 0.4ml (4 mg) of dexamethasone Group 2: 15ml 0.5% bupivacaine and 10ml (133mg) of LB (Exparel) and 5.4ml normal saline Group 3: 5ml 0.5% bupivacaine and 10ml LB (Exparel) and 0.4ml (4 mg) dexamethasone and 5ml normal saline&#xD;
Dexamethasone: steroid that will be used in control as well as in group 3 to see if effect with liposomal bupivicaine is prolonged as has been shown with standard</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Reported Postoperative Pain: VAS</title>
          <description>Patient-reported post-operative VAS pain (on a scale of 0-10 with zero implying no pain and 10 indicating severe pain), measured post operatively, in 8-hour increments, for a total of 96 hours post-surgery, Patients will be prompted via text message to provide VAS pain every 8 hours. If a response text message is not received, a phone call will be made to obtain the information. Patients who do not have a smart phone will receive a phone call or keep a personal log of VAS pain.</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Postoperative day 1 VAS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" spread="1.9"/>
                    <measurement group_id="O2" value="3.5" spread="2.2"/>
                    <measurement group_id="O3" value="2.4" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Postoperative day 2 VAS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" spread="1.8"/>
                    <measurement group_id="O2" value="2.8" spread="2.0"/>
                    <measurement group_id="O3" value="2.8" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Postoperative day 3 VAS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.4" spread="1.6"/>
                    <measurement group_id="O2" value="3.2" spread="2.1"/>
                    <measurement group_id="O3" value="2.1" spread="1.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Postoperative day 4 VAS</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" spread="1.3"/>
                    <measurement group_id="O2" value="2.9" spread="1.9"/>
                    <measurement group_id="O3" value="2.3" spread="1.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Patient Reported Post Operative Opioid Use</title>
        <description>Patient-reported post-operative opioid use (converted to morphine equivalents), collected post operatively, in 8-hour increments, for a total of 96 hours post-surgery Patients will be prompted via text message to provide the amount of narcotics (number of pills converted to morphine equivalents) taken over the course of the previous 8 hours. If a response text message is not received, a phone call will be made to obtain the information. Patients who do not have a smart phone will receive a phone call or keep a personal log of narcotic use.</description>
        <time_frame>4 days post procedure</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Control/Bupivicaine+DMSO</title>
            <description>Group 1 will serve as the control and receive the standard injection consisting 30 ml of 0.5% bupivacaine and 0.4ml (4 mg) of dexamethasone.&#xD;
Dexamethasone: steroid that will be used in control as well as in group 3 to see if effect with liposomal bupivicaine is prolonged as has been shown with standard bupivicaine.</description>
          </group>
          <group group_id="O2">
            <title>Liposomal Bupivicaine</title>
            <description>Group 2 will receive a block with 15ml 0.5% bupivacaine and 10ml (133mg) of liposomal bupivicaine (Exparel) and 5.4ml of Normal Saline&#xD;
liposomal bupivicaine: The medication administered in the interscalene block is the intervention in this study. There are three different types of interscalene blocks that will be administered in order to compare the independent effectiveness of LB with the effectiveness of LB plus dexamethasone. Study participants will be randomized into one of three groups. The treatment groups are listed below:&#xD;
Group 1 (Control): 30 ml of 0.5% bupivacaine and 0.4ml (4 mg) of dexamethasone Group 2: 15ml 0.5% bupivacaine and 10ml (133mg) of LB (Exparel) and 5.4ml normal saline Group 3: 5ml 0.5% bupivacaine and 10ml LB (Exparel) and 0.4ml (4 mg) dexamethasone and 5ml normal saline</description>
          </group>
          <group group_id="O3">
            <title>Liposomal Bupivicaine + DMSO</title>
            <description>Group 3 will receive 15ml of 0.5% bupivicaine and 10ml (133mg) of Liposomal Bupivicaine (Exparel) and 0.4ml (4mg) dexamethasone and 5ml normal saline&#xD;
There are three different types of interscalene blocks that will be administered in order to compare the independent effectiveness of LB with the effectiveness of LB plus dexamethasone. Study participants will be randomized into one of three groups. The treatment groups are listed below:&#xD;
Group 1 (Control): 30 ml of 0.5% bupivacaine and 0.4ml (4 mg) of dexamethasone Group 2: 15ml 0.5% bupivacaine and 10ml (133mg) of LB (Exparel) and 5.4ml normal saline Group 3: 5ml 0.5% bupivacaine and 10ml LB (Exparel) and 0.4ml (4 mg) dexamethasone and 5ml normal saline&#xD;
Dexamethasone: steroid that will be used in control as well as in group 3 to see if effect with liposomal bupivicaine is prolonged as has been shown with standard bupivicaine.</description>
          </group>
        </group_list>
        <measure>
          <title>Patient Reported Post Operative Opioid Use</title>
          <description>Patient-reported post-operative opioid use (converted to morphine equivalents), collected post operatively, in 8-hour increments, for a total of 96 hours post-surgery Patients will be prompted via text message to provide the amount of narcotics (number of pills converted to morphine equivalents) taken over the course of the previous 8 hours. If a response text message is not received, a phone call will be made to obtain the information. Patients who do not have a smart phone will receive a phone call or keep a personal log of narcotic use.</description>
          <units>morphine milligram equivalents</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
                <count group_id="O2" value="24"/>
                <count group_id="O3" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>POD 1 MME</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.5" spread="22.0"/>
                    <measurement group_id="O2" value="22.8" spread="22.3"/>
                    <measurement group_id="O3" value="18.8" spread="12.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>POD 2 MME</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.1" spread="22.9"/>
                    <measurement group_id="O2" value="21.9" spread="24.9"/>
                    <measurement group_id="O3" value="22.8" spread="17.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>POD 3 MME</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.7" spread="24.9"/>
                    <measurement group_id="O2" value="17.8" spread="21.8"/>
                    <measurement group_id="O3" value="14.4" spread="14.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>POD 4 MME</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.1" spread="17.9"/>
                    <measurement group_id="O2" value="18.1" spread="23.9"/>
                    <measurement group_id="O3" value="16.8" spread="16.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>96 hours</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Control/Bupivicaine +DMSO</title>
          <description>Group 1 will serve as the control and receive the standard injection consisting 30 ml of 0.5% bupivacaine and 0.4ml (4 mg) of dexamethasone.&#xD;
Dexamethasone: steroid that will be used in control as well as in group 3 to see if effect with liposomal bupivicaine is prolonged as has been shown with standard bupivicaine.</description>
        </group>
        <group group_id="E2">
          <title>Liposomal Bupivicaine</title>
          <description>Group 2 will receive a block with 15ml 0.5% bupivacaine and 10ml (133mg) of liposomal bupivicaine (Exparel) and 5.4ml of Normal Saline&#xD;
liposomal bupivicaine: The medication administered in the interscalene block is the intervention in this study. There are three different types of interscalene blocks that will be administered in order to compare the independent effectiveness of LB with the effectiveness of LB plus dexamethasone. Study participants will be randomized into one of three groups. The treatment groups are listed below:&#xD;
Group 1 (Control): 30 ml of 0.5% bupivacaine and 0.4ml (4 mg) of dexamethasone Group 2: 15ml 0.5% bupivacaine and 10ml (133mg) of LB (Exparel) and 5.4ml normal saline Group 3: 5ml 0.5% bupivacaine and 10ml LB (Exparel) and 0.4ml (4 mg) dexamethasone and 5ml normal saline</description>
        </group>
        <group group_id="E3">
          <title>Liposomal Bupivicaine + DMS)</title>
          <description>Group 3 will receive 15ml of 0.5% bupivicaine and 10ml (133mg) of Liposomal Bupivicaine (Exparel) and 0.4ml (4mg) dexamethasone and 5ml normal saline&#xD;
The treatment groups are listed below:&#xD;
Group 1 (Control): 30 ml of 0.5% bupivacaine and 0.4ml (4 mg) of dexamethasone Group 2: 15ml 0.5% bupivacaine and 10ml (133mg) of LB (Exparel) and 5.4ml normal saline Group 3: 5ml 0.5% bupivacaine and 10ml LB (Exparel) and 0.4ml (4 mg) dexamethasone and 5ml normal saline&#xD;
Dexamethasone: steroid that will be used in control as well as in group 3 to see if effect with liposomal bupivicaine is prolonged as has been shown with standard</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="26"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="26"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="26"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="26"/>
              </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="26"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="24"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="26"/>
              </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>Brian Badman</name_or_title>
      <organization>AHNI Orthopedics</organization>
      <phone>3178328800</phone>
      <email>bbadman@gmail.com</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/NCT03822182
org study id: 1806933448
nct id: NCT03822182
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This document is a protocol for a human research study. This study is to be conducted
      according to United States standards of Good Clinical Practice in accordance with applicable
      Federal regulations and institutional research policies and procedures.

      Liposomal bupivacaine (LB) has been shown to decrease post-operative pain and narcotic use
      when administered perioperatively as a local injection during arthroplasty procedures.
      Studies have also demonstrated that LB used in conjunction with dexamethasone may increase
      the duration of effectiveness of LB. This study seeks to evaluate if there is a difference in
      post-operative pain and narcotic use when LB is administered in an interscalene block during
      outpatient rotator cuff repair surgery. Furthermore, this study aims to determine if the
      addition of dexamethasone with LB results in a prolonged decrease in post-operative pain and
      a reduction in narcotic use.
Outpatient surgery has become the gold standard for arthroscopic rotator cuff repair.
      Innovations in pain management with regional anesthesia and multimodal techniques have
      greatly contributed to this transition over the past several decades. Despite overall
      improvements, uncontrolled postoperative pain leads to prolonged ambulatory stays, increased
      patient dissatisfaction, unexpected admissions to the hospital or visits to the Emergency
      Room after surgery, and a greater incidence of complications. Furthermore, in the wake of the
      "opioid epidemic", concerns with narcotic consumption and addiction have become heightened
      with regulations and laws recently enacted making prescribing and managing postoperative pain
      ever more difficult.

      Interscalene nerve blockade for shoulder procedures has become an increasingly common
      technique to provide perioperative pain control with good efficacy, low complication rates
      and reduced narcotic consumption. While the utilization of ultrasound to help administer the
      block has aided in the accuracy providing a more consistent analgesic effect, its overall
      short duration (12-24 hours) remains one of the major limitations of this technique.
      Modalities to prolong its effect have included use of indwelling catheters and the addition
      of perineural dexamethasone.

      Recently, liposomal bupivacaine (LB) (Exparel) was approved for single shot interscalene
      administration by the FDA. This medication has been purported to provide up to 72 hours of
      extended release of bupivacaine via its multivesicular and honeycomb-like structure that
      predictably breaks down resulting in a slow and sustained release of the medication.9
      Although numerous studies have been conducted and several meta-analyses performed looking at
      the overall efficacy of local injections of LB for operative procedures in an inpatient
      setting, no study to date has independently assessed its efficacy in the new perineural
      indication for outpatient shoulder surgery. Furthermore, no study to date has compared the
      use of LB to the use of LB with dexamethasone in a perineural indication to see if the
      duration of efficacy is further prolonged with the addition of dexamethasone. All existing
      literature is in regard to use of liposomal bupivacaine injected locally within the surgical
      site. This will be the first study to examine the perineural use of LB for outpatient
      shoulder surgery, and to determine if there is a prolonged decrease in pain and a decrease in
      narcotic consumption with the use of LB with dexamethasone when delivered as an interscalene
      block in an ambulatory setting.

      Utilizing a prospective randomized controlled trial, this study seeks to evaluate if there is
      a difference in post-operative pain and narcotic use when LB is administered in an
      interscalene block during outpatient rotator cuff repair surgery. Furthermore, this study
      aims to determine if the addition of dexamethasone with LB results in a prolonged decrease in
      post-operative pain and an overall reduction in narcotic use.

      Primary Aims & Objective

      Aim 1a: To determine if the use of LB in an interscalene block decreases patient-reported
      post-operative visual analogue pain scale (VAS) in patients undergoing outpatient rotator
      cuff surgery

      Hypothesis: There will be a decrease in the visual analogue pain scale for up to 72 hours
      post-operatively among participants who receive LB or LB plus dexamethasone, as compared to
      the control group (bupivacaine plus dexamethasone).

      Objective: Utilizing a prospective randomized controlled trial, post-operative
      patient-reported VAS pain (on a scale of 1-10) will be collected 3 times per day (every 8
      hours) for 5 post-operative days (PODs), corresponding to a total of 120 hours after surgery.
      For each 24-hour period (corresponding to each POD), the pain scores will be averaged and
      compared between the three treatment groups (control, LB, and LB plus dexamethasone) for each
      of the 5 PODs.

      Aim 1b: To determine if the use of LB plus dexamethasone in an interscalene block decreases
      patient-reported post-operative VAS pain for a longer duration than the LB or the control
      group (bupivacaine plus dexamethasone) in patients undergoing outpatient rotator cuff surgery

      Hypothesis: There will be a decrease in visual analogue pain scale for greater than 72 hours
      post-operatively among participants who receive LB plus dexamethasone, as compared to the LB
      and the control group (bupivacaine plus dexamethasone).

      Objective: Utilizing a prospective randomized controlled trial, post-operative
      patient-reported visual analogue pain scale (on a scale of 1-10) will be collected 3 times
      per day (every 8 hours) for 5 post-operative days (PODs), corresponding to a total of 120
      hours after surgery. For each 24-hour period (corresponding to each POD), the pain scores
      will be averaged and compared between the three treatment groups (control, LB, and LB plus
      dexamethasone) for each of the 5 PODs.

      Secondary Aims & Objectives

      Aim 2a: To determine if there is a difference in time at which post-operative narcotics are
      first used among three groups receiving different interscalene blocks (LB plus dexamethasone,
      LB, and control) in patients undergoing outpatient rotator cuff surgery.

      Hypothesis: Narcotic use will begin at a later time among those receiving LB plus
      dexamethasone, as compared to the LB and the control group (bupivacaine plus dexamethasone).

      Objective: Utilizing a prospective randomized controlled trial, narcotic use will be
      collected at 8-hour increments for a total of 5 post-operative days (PODs), corresponding to
      a period of 120 hours post-surgery. The 8-hour time period during which a participant first
      begins using a narcotic will be recorded and compared between three treatment groups
      (control, LB, and LB plus dexamethasone).

      Aim 2b: To determine if there is a difference in patient-reported post-operative narcotic use
      (measured in morphine equivalents) among three groups receiving different interscalene blocks
      (LB plus dexamethasone, LB, and control) in patients undergoing outpatient rotator cuff
      surgery.

      Hypothesis: There will be a decrease in cumulative narcotic use (measured in morphine
      equivalents) among participants who receive LB plus dexamethasone, as compared to the LB and
      the control group (bupivacaine plus dexamethasone).

      Objective: Utilizing a prospective randomized controlled trial, post-operative
      patient-reported narcotic use (measured by the number of tablets ingested and converted to
      morphine equivalents) will be collected 3 times per day at 8-hour increments for a total of 5
      post-operative days (PODs), corresponding to a total of 120 hours after surgery. For each
      24-hour period (corresponding to each POD), narcotic use will be tabulated and compared
      between three treatment groups (control, LB, and LB plus dexamethasone). Furthermore,
      cumulative narcotic use during the 5-day (120 hour) study period will be calculated and
      compared between three treatment groups (control, LB, and LB plus dexamethasone).
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The medication administered in the interscalene block is the intervention in this study. There are three different types of interscalene blocks that will be administered in order to compare the independent effectiveness of LB with the effectiveness of LB plus dexamethasone. Study participants will be randomized into one of three groups. The treatment groups are listed below:
Group 1 (Control) Group 2 Group 3 30 ml of 0.5% bupivacaine and 0.4ml. of dexamethasone 15ml 0.5% bupivacaine and 10ml of LB (Exparel) and 5.4ml normal saline 15ml 0.5% bupivacaine and 10ml LB (Exparel) and 0.4ml dexamethasone and 5ml normal saline
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
masking description: This is a double-blinded study, thus, neither the surgeon nor the patient will know which type of interscalene block is used. A total of 78 envelopes containing will be generated consisting of 26 with Group 1", 26 with "Group 2" and 26 with "Group 3" designation. Envelopes will be sealed and randomly chosen by the anesthesiologist prior to surgery. The anesthesiologist will randomly select one of the envelopes which will determine the treatment group and indicate medications that will be included in the interscalene block. Patients will be blinded to the medication utilized as well as the treating surgeon.
measure: Patient Reported Postoperative Pain: VAS
time frame: 4 days post procedure
description: Patient-reported post-operative VAS pain (on a scale of 0-10 with zero implying no pain and 10 indicating severe pain), measured post operatively, in 8-hour increments, for a total of 96 hours post-surgery, Patients will be prompted via text message to provide VAS pain every 8 hours. If a response text message is not received, a phone call will be made to obtain the information. Patients who do not have a smart phone will receive a phone call or keep a personal log of VAS pain.
measure: Patient Reported Post Operative Opioid Use
time frame: 4 days post procedure
description: Patient-reported post-operative opioid use (converted to morphine equivalents), collected post operatively, in 8-hour increments, for a total of 96 hours post-surgery Patients will be prompted via text message to provide the amount of narcotics (number of pills converted to morphine equivalents) taken over the course of the previous 8 hours. If a response text message is not received, a phone call will be made to obtain the information. Patients who do not have a smart phone will receive a phone call or keep a personal log of narcotic use.
arm group label: Control/Bupivicaine +DMSO
arm group type: Other
description: Group 1 will serve as the control and receive the standard injection consisting 30 ml of 0.5% bupivacaine and 0.4ml (4 mg) of dexamethasone.
arm group label: Liposomal bupivicaine
arm group type: Active Comparator
description: Group 2 will receive a block with 15ml 0.5% bupivacaine and 10ml (133mg) of liposomal bupivicaine (Exparel) and 5.4ml of Normal Saline
arm group label: Liposomal Bupivicaine +DMSO
arm group type: Active Comparator
description: Group 3 will receive 15ml of 0.5% bupivicaine and 10ml (133mg) of Liposomal Bupivicaine (Exparel) and 0.4ml (4mg) dexamethasone and 5ml normal saline
intervention type: Drug
intervention name: liposomal bupivicaine
description: The medication administered in the interscalene block is the intervention in this study. There are three different types of interscalene blocks that will be administered in order to compare the independent effectiveness of LB with the effectiveness of LB plus dexamethasone. Study participants will be randomized into one of three groups. The treatment groups are listed below:
Group 1 (Control): 30 ml of 0.5% bupivacaine and 0.4ml (4 mg) of dexamethasone Group 2: 15ml 0.5% bupivacaine and 10ml (133mg) of LB (Exparel) and 5.4ml normal saline Group 3: 5ml 0.5% bupivacaine and 10ml LB (Exparel) and 0.4ml (4 mg) dexamethasone and 5ml normal saline
arm group label: Liposomal Bupivicaine +DMSO
arm group label: Liposomal bupivicaine
other name: Exparel
intervention type: Drug
intervention name: Dexamethasone
description: steroid that will be used in control as well as in group 3 to see if effect with liposomal bupivicaine is prolonged as has been shown with standard bupivicaine.
arm group label: Control/Bupivicaine +DMSO
arm group label: Liposomal Bupivicaine +DMSO
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: brian badman, MD
role: Principal Investigator
affiliation: Indiana University
facility: 
country: United States
citation: Cao X, Pan F. Comparison of liposomal bupivacaine infiltration versus interscalene nerve block for pain control in total shoulder arthroplasty: A meta-analysis of randomized control trails. Medicine (Baltimore). 2017 Sep;96(39):e8079. doi: 10.1097/MD.0000000000008079.
PMID: 28953626
citation: Bramlett K, Onel E, Viscusi ER, Jones K. A randomized, double-blind, dose-ranging study comparing wound infiltration of DepoFoam bupivacaine, an extended-release liposomal bupivacaine, to bupivacaine HCl for postsurgical analgesia in total knee arthroplasty. Knee. 2012 Oct;19(5):530-6. doi: 10.1016/j.knee.2011.12.004. Epub 2012 Jan 28.
PMID: 22285545
citation: Surdam JW, Licini DJ, Baynes NT, Arce BR. The use of exparel (liposomal bupivacaine) to manage postoperative pain in unilateral total knee arthroplasty patients. J Arthroplasty. 2015 Feb;30(2):325-9. doi: 10.1016/j.arth.2014.09.004. Epub 2014 Sep 16.
PMID: 25282071
responsible party type: Principal Investigator
investigator affiliation: Indiana University
investigator full name: Brian Badman
investigator title: Principal Investigator, Clinical Associate Professor, Department of Orthopedic Surgery
mesh term: Pain, Postoperative
mesh term: Rotator Cuff Injuries
mesh term: Dexamethasone
mesh term: Bupivacaine
sharing ipd: No
ipd description: No plans to share
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 