<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/NCT03253198</url>
  </required_header>
  <id_info>
    <org_study_id>2017SNam</org_study_id>
    <nct_id>NCT03253198</nct_id>
  </id_info>
  <brief_title>Prospective RCT Comparing Perioperative Pain</brief_title>
  <official_title>Preoperative Interscalene Nerve Block Plus Postoperative Local Intra-operative Analgesic Injection vs Preoperative Interscalene Nerve Block Plus Postoperative Saline Injection in Patients Undergoing Shoulder Arthroplasty: a Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rothman Institute Orthopaedics</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rothman Institute Orthopaedics</source>
  <oversight_info>
    <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 study is a non-blinded randomized controlled trial comparing the use of a preoperative&#xD;
      &quot;mini&quot; block plus postoperative local infiltration of Exparel (liposomal form of bupivacaine)&#xD;
      versus a partial single shot nerve block in subjects undergoing primary reverse or total&#xD;
      shoulder arthroplasty to see which is more effective in controlling surgery related pain. To&#xD;
      do so, we will utilize the Visual Analog Scale (VAS) to measure pain intensity. Opioid&#xD;
      consumption will be recorded on a Pain Monitoring Sheet.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2016</start_date>
  <completion_date type="Actual">July 2017</completion_date>
  <primary_completion_date type="Actual">June 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>morphine and morphine equivalent consumption</measure>
    <time_frame>24 hours post surgery</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">156</enrollment>
  <condition>Arthroplasty Shoulder</condition>
  <arm_group>
    <arm_group_label>Preoperative block plus saline</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Preoperative interscalene brachial plexus single-shot block using 25ml of 0.5% Ropivicaine plus postoperative 40cc local infiltration of saline</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Preoperative block plus Bupivacaine extended-release liposome</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Interscalene brachial plexus single shot block preoperatively (25 ml of 0.5% ropivicaine) + Postoperative Infiltration of local anesthetic/analgesic (20 cc Bupivacaine extended-release liposome injection (Exparel) + Diluted in 20cc of Saline into the capsule, subscapularis, deltoid, pectoralis major and subcutaneous tissues)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Saline</intervention_name>
    <description>A preoperative interscalene brachial plexus single-shot block using 25 ml of 0.5% Ropivicaine plus saline injection postoperative</description>
    <arm_group_label>Preoperative block plus saline</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Bupivacaine liposome</intervention_name>
    <description>an interscalene brachial plexus single shot block preoperatively (25 ml of 0.5% ropivicaine) + Postoperative Infiltration of local anesthetic/analgesic (20 cc Bupivacaine extended-release liposome injection (Exparel) + Diluted in 20cc of Saline into the capsule, subscapularis, deltoid, pectoralis major and subcutaneous tissues)</description>
    <arm_group_label>Preoperative block plus Bupivacaine extended-release liposome</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All individuals undergoing primary reverse and total shoulder arthroplasty by the&#xD;
             shoulder service at Thomas Jefferson University Hospital, Methodist Hospital or&#xD;
             Rothman Specialty Hospital.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Psychiatric illness as defined by co-morbid diagnosis of bipolar disorder or&#xD;
             schizophrenia&#xD;
&#xD;
          -  Revision arthroplasty or arthroplasty for fracture&#xD;
&#xD;
          -  Unable/unwilling to consent for enrollment&#xD;
&#xD;
          -  Unable to complete postoperative pain survey&#xD;
&#xD;
          -  Known adverse drug reaction or allergy to the medications used&#xD;
&#xD;
          -  Chronic pain syndromes (including reflex sympathetic dystrophy, fibromyalgia, chronic&#xD;
             diffuse musculoskeletal pain)&#xD;
&#xD;
          -  Patients taking long acting opioid pain medications (including extended release opioid&#xD;
             pain medications and methadone)&#xD;
&#xD;
          -  Patients under the age of 18 years&#xD;
&#xD;
          -  Patients with history of hepatic disease&#xD;
&#xD;
          -  Pregnant or breastfeeding women.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Surena Namdari, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rothman Institute</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rothman Institute</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>May 18, 2018</last_update_submitted>
  <last_update_submitted_qc>May 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 22, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>
  <!-- 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/NCT03253198
org study id: 2017SNam
nct id: NCT03253198
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This study is a non-blinded randomized controlled trial comparing the use of a preoperative
      "mini" block plus postoperative local infiltration of Exparel (liposomal form of bupivacaine)
      versus a partial single shot nerve block in subjects undergoing primary reverse or total
      shoulder arthroplasty to see which is more effective in controlling surgery related pain. To
      do so, we will utilize the Visual Analog Scale (VAS) to measure pain intensity. Opioid
      consumption will be recorded on a Pain Monitoring Sheet.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: morphine and morphine equivalent consumption
time frame: 24 hours post surgery
arm group label: Preoperative block plus saline
arm group type: Active Comparator
description: Preoperative interscalene brachial plexus single-shot block using 25ml of 0.5% Ropivicaine plus postoperative 40cc local infiltration of saline
arm group label: Preoperative block plus Bupivacaine extended-release liposome
arm group type: Active Comparator
description: Interscalene brachial plexus single shot block preoperatively (25 ml of 0.5% ropivicaine) + Postoperative Infiltration of local anesthetic/analgesic (20 cc Bupivacaine extended-release liposome injection (Exparel) + Diluted in 20cc of Saline into the capsule, subscapularis, deltoid, pectoralis major and subcutaneous tissues)
intervention type: Drug
intervention name: Saline
description: A preoperative interscalene brachial plexus single-shot block using 25 ml of 0.5% Ropivicaine plus saline injection postoperative
arm group label: Preoperative block plus saline
intervention type: Drug
intervention name: Bupivacaine liposome
description: an interscalene brachial plexus single shot block preoperatively (25 ml of 0.5% ropivicaine) + Postoperative Infiltration of local anesthetic/analgesic (20 cc Bupivacaine extended-release liposome injection (Exparel) + Diluted in 20cc of Saline into the capsule, subscapularis, deltoid, pectoralis major and subcutaneous tissues)
arm group label: Preoperative block plus Bupivacaine extended-release liposome
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Surena Namdari, MD
role: Principal Investigator
affiliation: Rothman Institute
facility: 
country: United States
responsible party type: Sponsor
mesh term: Bupivacaine
sharing ipd: No