<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/NCT03290196</url>
  </required_header>
  <id_info>
    <org_study_id>EXPAREL</org_study_id>
    <nct_id>NCT03290196</nct_id>
  </id_info>
  <brief_title>The Effect of EXPAREL® on Postsurgical Pain, and the Use of Narcotics</brief_title>
  <official_title>The Effect of EXPAREL® on Postsurgical Pain, and the Use of Narcotics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Andrews Research &amp; Education Foundation</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pacira Pharmaceuticals, Inc</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Andrews Research &amp; Education Foundation</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>
      Patients undergoing shoulder rotator cuff surgery in an outpatient setting are the focus of&#xD;
      this study. The purpose of this study is to determine if the product EXPAREL® can be used as&#xD;
      a safe alternative in shoulder surgery to pain pumps, while limiting narcotic use and&#xD;
      providing appropriate postoperative pain control.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Based on prior research, it is hypothesized EXPAREL® can potentially be used as a local&#xD;
      anesthetic option after undergoing an arthroscopic rotator cuff repair in the outpatient&#xD;
      setting. Conducting this study, will allow the option for a surgeon to administer a local&#xD;
      anesthetic, in a single injection, to the exact location of the surgical procedure and in a&#xD;
      sterile environment. The purpose of this pilot study is to determine if EXPAREL® can be used&#xD;
      as a safe alternative to current post-operative pain control methods, while limiting narcotic&#xD;
      use and providing appropriate postoperative analgesia.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Patients pain was not regulated well with this product.&#xD;
  </why_stopped>
  <start_date type="Actual">September 3, 2015</start_date>
  <completion_date type="Anticipated">July 2022</completion_date>
  <primary_completion_date type="Anticipated">January 2022</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Daily Log of Pain Score</measure>
    <time_frame>2 weeks</time_frame>
    <description>Daily reported patient numeric pain rating</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Daily Log of Narcotic Medication Usage</measure>
    <time_frame>2 weeks</time_frame>
    <description>Number of narcotic medication consumed</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>American Shoulder and Elbow Surgeons Shoulder Score (ASES)</measure>
    <time_frame>2 week follow-up visit</time_frame>
    <description>Pain score measured utilizing patient questionnaire answers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>American Shoulder and Elbow Surgeons Shoulder Score (ASES)</measure>
    <time_frame>2 week follow-up visit</time_frame>
    <description>Function score measured utilizing patient questionnaire answers</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Rotator Cuff Tear</condition>
  <arm_group>
    <arm_group_label>EXPAREL 1.3 % in 20 ML Injection</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>EXPAREL (bupivacaine liposome injectable suspension, 20 mL single use vial, 1.3% [13.3 mg/mL]) is a liposome injection of bupivacaine, an amide local anesthetic, indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia. EXPAREL dosage is based on the following factors:&#xD;
size of surgical site&#xD;
volume required to cover the area&#xD;
individual patient factors that may impact the safety of an amide local anesthetic&#xD;
maximum doe of 266 mg (20 mL)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>EXPAREL 1.3 % in 20 ML Injection</intervention_name>
    <description>EXPAREL single shot dose given as an analgesia for arthroscopic rotator cuff repair surgery.</description>
    <arm_group_label>EXPAREL 1.3 % in 20 ML Injection</arm_group_label>
    <other_name>bupivacaine liposome injectable suspension</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female&#xD;
&#xD;
          -  18-72 years of age&#xD;
&#xD;
          -  Subjects scheduled to undergo a rotator cuff repair with a subacromial decompression&#xD;
             by one of the protocol investigators&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Planned concomitant glenoid labral repair&#xD;
&#xD;
          -  Previous open shoulder surgery&#xD;
&#xD;
          -  Neurological deficit or other disability involving the surgical extremity&#xD;
&#xD;
          -  Anyone with a documented allergy to bupivicaine&#xD;
&#xD;
          -  Subjects that are not mentally competent to give consent&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Subjects with an intolerance to hydrocodone or oxycodone and/or brand name equivalent&#xD;
             combination medication&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>72 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James R Andrews, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Andrews Institute for Orthopaedics &amp; Sports Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Andrews Research &amp; Education Foundation</name>
      <address>
        <city>Gulf Breeze</city>
        <state>Florida</state>
        <zip>32561</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Johnson MD, Mickler T, Arthur GR, Rosenburg S, Wilson R. Bupivacaine with and without epinephrine for intercostal nerve block. J Cardiothorac Anesth. 1990 Apr;4(2):200-3. doi: 10.1016/0888-6296(90)90238-b.</citation>
    <PMID>2131867</PMID>
  </reference>
  <reference>
    <citation>Colombo G, Padera R, Langer R, Kohane DS. Prolonged duration local anesthesia with lipid-protein-sugar particles containing bupivacaine and dexamethasone. J Biomed Mater Res A. 2005 Nov 1;75(2):458-64. doi: 10.1002/jbm.a.30443.</citation>
    <PMID>16088895</PMID>
  </reference>
  <reference>
    <citation>Bergese SD, Onel E, Morren M, Morganroth J. Bupivacaine extended-release liposome injection exhibits a favorable cardiac safety profile. Reg Anesth Pain Med. 2012 Mar-Apr;37(2):145-51. doi: 10.1097/AAP.0b013e31823d0a80.</citation>
    <PMID>22266897</PMID>
  </reference>
  <reference>
    <citation>Portillo J, Kamar N, Melibary S, Quevedo E, Bergese S. Safety of liposome extended-release bupivacaine for postoperative pain control. Front Pharmacol. 2014 Apr 30;5:90. doi: 10.3389/fphar.2014.00090. eCollection 2014.</citation>
    <PMID>24817851</PMID>
  </reference>
  <reference>
    <citation>Candiotti K. Liposomal bupivacaine: an innovative nonopioid local analgesic for the management of postsurgical pain. Pharmacotherapy. 2012 Sep;32(9 Suppl):19S-26S. doi: 10.1002/j.1875-9114.2012.01183.x.</citation>
    <PMID>22956491</PMID>
  </reference>
  <reference>
    <citation>Cohen SM, Vogel JD, Marcet JE, Candiotti KA. Liposome bupivacaine for improvement in economic outcomes and opioid burden in GI surgery: IMPROVE Study pooled analysis. J Pain Res. 2014 Jun 24;7:359-66. doi: 10.2147/JPR.S63764. eCollection 2014.</citation>
    <PMID>25018650</PMID>
  </reference>
  <reference>
    <citation>Bagsby DT, Ireland PH, Meneghini RM. Liposomal bupivacaine versus traditional periarticular injection for pain control after total knee arthroplasty. J Arthroplasty. 2014 Aug;29(8):1687-90. doi: 10.1016/j.arth.2014.03.034. Epub 2014 Apr 4.</citation>
    <PMID>24793570</PMID>
  </reference>
  <reference>
    <citation>Singelyn FJ, Lhotel L, Fabre B. Pain relief after arthroscopic shoulder surgery: a comparison of intraarticular analgesia, suprascapular nerve block, and interscalene brachial plexus block. Anesth Analg. 2004 Aug;99(2):589-92, table of contents. doi: 10.1213/01.ANE.0000125112.83117.49.</citation>
    <PMID>15271745</PMID>
  </reference>
  <reference>
    <citation>Borgeat A, Ekatodramis G, Kalberer F, Benz C. Acute and nonacute complications associated with interscalene block and shoulder surgery: a prospective study. Anesthesiology. 2001 Oct;95(4):875-80. doi: 10.1097/00000542-200110000-00015.</citation>
    <PMID>11605927</PMID>
  </reference>
  <reference>
    <citation>Fredrickson MJ, Kilfoyle DH. Neurological complication analysis of 1000 ultrasound guided peripheral nerve blocks for elective orthopaedic surgery: a prospective study. Anaesthesia. 2009 Aug;64(8):836-44. doi: 10.1111/j.1365-2044.2009.05938.x.</citation>
    <PMID>19604186</PMID>
  </reference>
  <reference>
    <citation>Jeng CL, Torrillo TM, Rosenblatt MA. Complications of peripheral nerve blocks. Br J Anaesth. 2010 Dec;105 Suppl 1:i97-107. doi: 10.1093/bja/aeq273.</citation>
    <PMID>21148659</PMID>
  </reference>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 21, 2017</study_first_posted>
  <last_update_submitted>March 4, 2020</last_update_submitted>
  <last_update_submitted_qc>March 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Shoulder</keyword>
  <keyword>Rotator cuff</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>Bupivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>January 30, 2023</submitted>
    <returned>February 22, 2023</returned>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03290196
org study id: EXPAREL
nct id: NCT03290196
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Patients undergoing shoulder rotator cuff surgery in an outpatient setting are the focus of
      this study. The purpose of this study is to determine if the product EXPAREL® can be used as
      a safe alternative in shoulder surgery to pain pumps, while limiting narcotic use and
      providing appropriate postoperative pain control.
Based on prior research, it is hypothesized EXPAREL® can potentially be used as a local
      anesthetic option after undergoing an arthroscopic rotator cuff repair in the outpatient
      setting. Conducting this study, will allow the option for a surgeon to administer a local
      anesthetic, in a single injection, to the exact location of the surgical procedure and in a
      sterile environment. The purpose of this pilot study is to determine if EXPAREL® can be used
      as a safe alternative to current post-operative pain control methods, while limiting narcotic
      use and providing appropriate postoperative analgesia.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Daily Log of Pain Score
time frame: 2 weeks
description: Daily reported patient numeric pain rating
measure: Daily Log of Narcotic Medication Usage
time frame: 2 weeks
description: Number of narcotic medication consumed
measure: American Shoulder and Elbow Surgeons Shoulder Score (ASES)
time frame: 2 week follow-up visit
description: Pain score measured utilizing patient questionnaire answers
measure: American Shoulder and Elbow Surgeons Shoulder Score (ASES)
time frame: 2 week follow-up visit
description: Function score measured utilizing patient questionnaire answers
arm group label: EXPAREL 1.3 % in 20 ML Injection
arm group type: Other
description: EXPAREL (bupivacaine liposome injectable suspension, 20 mL single use vial, 1.3% [13.3 mg/mL]) is a liposome injection of bupivacaine, an amide local anesthetic, indicated for single-dose infiltration into the surgical site to produce postsurgical analgesia. EXPAREL dosage is based on the following factors:
size of surgical site
volume required to cover the area
individual patient factors that may impact the safety of an amide local anesthetic
maximum doe of 266 mg (20 mL)
intervention type: Drug
intervention name: EXPAREL 1.3 % in 20 ML Injection
description: EXPAREL single shot dose given as an analgesia for arthroscopic rotator cuff repair surgery.
arm group label: EXPAREL 1.3 % in 20 ML Injection
other name: bupivacaine liposome injectable suspension
criteria: 
gender: All
minimum age: 18 Years
maximum age: 72 Years
healthy volunteers: No
last name: James R Andrews, MD
role: Principal Investigator
affiliation: Andrews Institute for Orthopaedics & Sports Medicine
facility: 
country: United States
citation: Johnson MD, Mickler T, Arthur GR, Rosenburg S, Wilson R. Bupivacaine with and without epinephrine for intercostal nerve block. J Cardiothorac Anesth. 1990 Apr;4(2):200-3. doi: 10.1016/0888-6296(90)90238-b.
PMID: 2131867
citation: Colombo G, Padera R, Langer R, Kohane DS. Prolonged duration local anesthesia with lipid-protein-sugar particles containing bupivacaine and dexamethasone. J Biomed Mater Res A. 2005 Nov 1;75(2):458-64. doi: 10.1002/jbm.a.30443.
PMID: 16088895
citation: Bergese SD, Onel E, Morren M, Morganroth J. Bupivacaine extended-release liposome injection exhibits a favorable cardiac safety profile. Reg Anesth Pain Med. 2012 Mar-Apr;37(2):145-51. doi: 10.1097/AAP.0b013e31823d0a80.
PMID: 22266897
citation: Portillo J, Kamar N, Melibary S, Quevedo E, Bergese S. Safety of liposome extended-release bupivacaine for postoperative pain control. Front Pharmacol. 2014 Apr 30;5:90. doi: 10.3389/fphar.2014.00090. eCollection 2014.
PMID: 24817851
citation: Candiotti K. Liposomal bupivacaine: an innovative nonopioid local analgesic for the management of postsurgical pain. Pharmacotherapy. 2012 Sep;32(9 Suppl):19S-26S. doi: 10.1002/j.1875-9114.2012.01183.x.
PMID: 22956491
citation: Cohen SM, Vogel JD, Marcet JE, Candiotti KA. Liposome bupivacaine for improvement in economic outcomes and opioid burden in GI surgery: IMPROVE Study pooled analysis. J Pain Res. 2014 Jun 24;7:359-66. doi: 10.2147/JPR.S63764. eCollection 2014.
PMID: 25018650
citation: Bagsby DT, Ireland PH, Meneghini RM. Liposomal bupivacaine versus traditional periarticular injection for pain control after total knee arthroplasty. J Arthroplasty. 2014 Aug;29(8):1687-90. doi: 10.1016/j.arth.2014.03.034. Epub 2014 Apr 4.
PMID: 24793570
citation: Singelyn FJ, Lhotel L, Fabre B. Pain relief after arthroscopic shoulder surgery: a comparison of intraarticular analgesia, suprascapular nerve block, and interscalene brachial plexus block. Anesth Analg. 2004 Aug;99(2):589-92, table of contents. doi: 10.1213/01.ANE.0000125112.83117.49.
PMID: 15271745
citation: Borgeat A, Ekatodramis G, Kalberer F, Benz C. Acute and nonacute complications associated with interscalene block and shoulder surgery: a prospective study. Anesthesiology. 2001 Oct;95(4):875-80. doi: 10.1097/00000542-200110000-00015.
PMID: 11605927
citation: Fredrickson MJ, Kilfoyle DH. Neurological complication analysis of 1000 ultrasound guided peripheral nerve blocks for elective orthopaedic surgery: a prospective study. Anaesthesia. 2009 Aug;64(8):836-44. doi: 10.1111/j.1365-2044.2009.05938.x.
PMID: 19604186
citation: Jeng CL, Torrillo TM, Rosenblatt MA. Complications of peripheral nerve blocks. Br J Anaesth. 2010 Dec;105 Suppl 1:i97-107. doi: 10.1093/bja/aeq273.
PMID: 21148659
responsible party type: Sponsor
mesh term: Pain, Postoperative
mesh term: Rotator Cuff Injuries
mesh term: Bupivacaine
sharing ipd: No
submitted: January 30, 2023
returned: February 22, 2023