<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/NCT03816982</url>
  </required_header>
  <id_info>
    <org_study_id>STU 082018-017</org_study_id>
    <nct_id>NCT03816982</nct_id>
  </id_info>
  <brief_title>Interscalene Bupivacaine With Either Liposomal Bupivacaine or Continuous Peripheral Nerve Block for Shoulder Arthroscopy</brief_title>
  <official_title>Single-Injection Bupivacaine HCl Plus Either Single-Injection Liposomal Bupivacaine Interscalene Nerve Block or a Continuous Interscalene Nerve Block For Major Shoulder Arthroscopy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Texas Southwestern Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Texas Southwestern Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This investigation will be a prospective, randomized trial. The study population will consist&#xD;
      of adult patients scheduled to undergo major shoulder arthroscopy procedures with&#xD;
      anesthesiology at the Ambulatory Services Center (Outpatient Surgery Center). Forty-six&#xD;
      subjects will be enrolled in this study and will be randomized into one of two arms: 1)&#xD;
      Single-injection bupivacaine HCl plus a subsequent bupivacaine CISB, 2) Single-injection&#xD;
      bupivacaine HCl plus liposomal bupivacaine included in the same injection. These procedures&#xD;
      will take place, using an ultrasound-guided method, approximately one hour prior to surgical&#xD;
      procedure. Subjects will be followed for seven days to assess pain control by the Modified&#xD;
      Brief Pain Inventory (MBPI) survey and outcome factors related to study and procedure using&#xD;
      the American Shoulder and Elbow Surgeon Shoulder Score (ASES Shoulder Score).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Once potential candidates are identified, charts will be reviewed for initial data collection&#xD;
      and to determine if the patient meets inclusion criteria and is free of exclusion criteria.&#xD;
      Eligible individuals will be approached in clinic or will be called one to four days before&#xD;
      their scheduled procedure and introduced to the study. They will have the opportunity to have&#xD;
      the consent and HIPPA forms emailed to them to review before making the decision to&#xD;
      participate in the study.&#xD;
&#xD;
      After consent, subjects will be randomized and enrolled into the study. Subjects will be&#xD;
      randomized into one of two arms: 1) Single-injection bupivacaine HCl plus a subsequent&#xD;
      bupivacaine CISB, 2) Single-injection bupivacaine HCl plus liposomal bupivacaine included in&#xD;
      the same injection. Subjects in the first arm will undergo catheter placement with ultrasound&#xD;
      guidance by a regional anesthesiologist on the study team. A 20 mL single bolus ISB with&#xD;
      0.25% bupivacaine will be administered followed by catheter infusion of 0.125% bupivacaine at&#xD;
      a rate of 5 mL/hour postoperatively by the elastomeric pump. Subjects in the second arm will&#xD;
      be given a single injection Liposomal Bupivacaine ISB in the preoperative area by a regional&#xD;
      anesthesiologist on the study team. The injectate will include liposomal bupivacaine 10 mL&#xD;
      (133 mg) mixed with bupivacaine HCl 0.5% 10 mL.&#xD;
&#xD;
      Both groups will receive a standardized analgesic regimen which will include the following:&#xD;
      preoperative acetaminophen 15mg/kg up to 1gm PO and gabapentin 600 mg PO; intraoperative&#xD;
      dexamethasone 8mg IV, fentanyl 100 - 250 mcg IV, ketamine 30 -50mg IV, and ketorolac 0.5mg/kg&#xD;
      up to 30mg IV at conclusion of surgery; fentanyl IV in PACU as necessary; postoperative&#xD;
      regimen will include acetaminophen 15mg/kg up to 1gm PO q8hrs, ibuprofen 400 mg Q8 hrs and&#xD;
      tramadol 50 mg q4hrs prn. For continued breakthrough postoperative pain unrelieved adequately&#xD;
      by tramadol a patient may receive oxycodone 5mg PO every 4 hours as needed.&#xD;
&#xD;
      Subjects in both groups will receive baseline ASES Shoulder Score assessments before the&#xD;
      block and procedure, and again in postoperative days 1-7. Additionally, a daily MBPI Short&#xD;
      Form will be adminstered for the seven days post operation. The primary endpoint is to assess&#xD;
      the median pain score on POD 1 using the MBPI Short form. Secondary endpoints include&#xD;
      Cumulative Area Under Curve (AUC) median pain score on POD1-3, opioid consumption through&#xD;
      POD3, satisfaction with pain treatment, block duration, success rate, amount of&#xD;
      analgesia/sedation used for it; and adverse effects attributed to either the block or&#xD;
      catheter, and functionality of the surgical arm.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 11, 2019</start_date>
  <completion_date type="Actual">December 30, 2022</completion_date>
  <primary_completion_date type="Actual">December 12, 2022</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>
    <intervention_model_description>A randomized prospective noninferiority trial to assess the difference, if any, in median pain scores between two block methods using bupivacaine HCl and/or Liposomal bupivacaine, with the catheter method or single shot administration.</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Median pain score on POD1</measure>
    <time_frame>24 hours</time_frame>
    <description>Median pain score on POD1 as measured by the MBPI Short Form</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cumulative Area under Curve median pain score on POD1-3</measure>
    <time_frame>72 hours</time_frame>
    <description>Median pain score on POD1-3 as measured by the MBPI Short Form</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Shoulder Pain</condition>
  <arm_group>
    <arm_group_label>Bupivacaine HCl/Bupivacaine CISB</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>23 patients will be enrolled to receive a single-injection bupivacaine HCL interscalene block with bupivacaine CISB added.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Liposomal Bupivacaine Added to Interscalene Block</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>23 patients will be enrolled to receive a single-injection bupivacaine HCl interscalene block with liposomal bupivacaine added to same injection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Single-injection bupivacaine HCl plus liposomal bupivacaine</intervention_name>
    <description>Patients in the liposomal bupivacaine with added bupivacaine HCl ISB group will be given a single injection LB ISB in the preoperative area only by faculty who are part of the regional anesthesia division. The injectate will include liposomal bupivacaine 10ml (133mg) mixed with bupivacaine HCl 0.5% 10 ml.</description>
    <arm_group_label>Liposomal Bupivacaine Added to Interscalene Block</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Single-injection bupivacaine HCl plus a subsequent bupivacaine CISB</intervention_name>
    <description>Patients in the bupivacaine CISB group will undergo catheter placement with ultrasound guidance only by faculty who are part of the regional anesthesia division. A 20 mL single bolus ISB with 0.25% bupivacaine will be administered followed by catheter infusion of 0.125% bupivacaine at a rate of 5mL/hour postoperatively by the ON-Q pump</description>
    <arm_group_label>Bupivacaine HCl/Bupivacaine CISB</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients ≥ 18 years&#xD;
&#xD;
          -  Individuals presenting for major shoulder arthroscopy procedures at Ambulatory&#xD;
             Services Center (Outpatient Surgery Center) -that include rotator cuff repair and&#xD;
             biceps tenodesis&#xD;
&#xD;
          -  Patient is able to provide informed consent to participate in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy to amide local anesthetic, liposomal bupivacaine or other medication involving&#xD;
             liposomal formulation&#xD;
&#xD;
          -  Preexisting neurological deficits involving or potentially involving the ipsilateral&#xD;
             brachial plexus&#xD;
&#xD;
          -  Preexisting contralateral vocal fold paralysis or recurrent laryngeal paralysis&#xD;
&#xD;
          -  Psychiatric or cognitive disorders that could interfere with perioperative evaluation&#xD;
             including drug or alcohol abuse&#xD;
&#xD;
          -  Chronic pain conditions&#xD;
&#xD;
          -  Preoperative opioid consumption greater than 20 mg oral morphine equivalent.&#xD;
&#xD;
          -  Any contraindication to interscalene nerve block including any local disorder of the&#xD;
             skin where blockade is to be performed which would prevent safe performance of the&#xD;
             block&#xD;
&#xD;
          -  Any coagulation abnormality which would be a contraindication for block placement&#xD;
&#xD;
          -  Preoperative chronic renal dysfunction requiring renal replacement therapy or a serum&#xD;
             creatinine greater than 1.4 mg/dL&#xD;
&#xD;
          -  Body mass index &gt;50&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Incarceration&#xD;
&#xD;
          -  ASA classification greater than 3&#xD;
&#xD;
          -  Inability to provide informed consent&#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>Anthony T Machi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>UT Southwestern Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>UT Southwestern Medical Center</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75390</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>January 19, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>August 22, 2023</last_update_submitted>
  <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 23, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Texas Southwestern Medical Center</investigator_affiliation>
    <investigator_full_name>Anthony Machi</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shoulder Pain</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Bupivacaine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No study data will be shared with outside entities or non-IRB approved study personnel.</ipd_description>
  </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/NCT03816982
org study id: STU 082018-017
nct id: NCT03816982
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
This investigation will be a prospective, randomized trial. The study population will consist
      of adult patients scheduled to undergo major shoulder arthroscopy procedures with
      anesthesiology at the Ambulatory Services Center (Outpatient Surgery Center). Forty-six
      subjects will be enrolled in this study and will be randomized into one of two arms: 1)
      Single-injection bupivacaine HCl plus a subsequent bupivacaine CISB, 2) Single-injection
      bupivacaine HCl plus liposomal bupivacaine included in the same injection. These procedures
      will take place, using an ultrasound-guided method, approximately one hour prior to surgical
      procedure. Subjects will be followed for seven days to assess pain control by the Modified
      Brief Pain Inventory (MBPI) survey and outcome factors related to study and procedure using
      the American Shoulder and Elbow Surgeon Shoulder Score (ASES Shoulder Score).
Once potential candidates are identified, charts will be reviewed for initial data collection
      and to determine if the patient meets inclusion criteria and is free of exclusion criteria.
      Eligible individuals will be approached in clinic or will be called one to four days before
      their scheduled procedure and introduced to the study. They will have the opportunity to have
      the consent and HIPPA forms emailed to them to review before making the decision to
      participate in the study.

      After consent, subjects will be randomized and enrolled into the study. Subjects will be
      randomized into one of two arms: 1) Single-injection bupivacaine HCl plus a subsequent
      bupivacaine CISB, 2) Single-injection bupivacaine HCl plus liposomal bupivacaine included in
      the same injection. Subjects in the first arm will undergo catheter placement with ultrasound
      guidance by a regional anesthesiologist on the study team. A 20 mL single bolus ISB with
      0.25% bupivacaine will be administered followed by catheter infusion of 0.125% bupivacaine at
      a rate of 5 mL/hour postoperatively by the elastomeric pump. Subjects in the second arm will
      be given a single injection Liposomal Bupivacaine ISB in the preoperative area by a regional
      anesthesiologist on the study team. The injectate will include liposomal bupivacaine 10 mL
      (133 mg) mixed with bupivacaine HCl 0.5% 10 mL.

      Both groups will receive a standardized analgesic regimen which will include the following:
      preoperative acetaminophen 15mg/kg up to 1gm PO and gabapentin 600 mg PO; intraoperative
      dexamethasone 8mg IV, fentanyl 100 - 250 mcg IV, ketamine 30 -50mg IV, and ketorolac 0.5mg/kg
      up to 30mg IV at conclusion of surgery; fentanyl IV in PACU as necessary; postoperative
      regimen will include acetaminophen 15mg/kg up to 1gm PO q8hrs, ibuprofen 400 mg Q8 hrs and
      tramadol 50 mg q4hrs prn. For continued breakthrough postoperative pain unrelieved adequately
      by tramadol a patient may receive oxycodone 5mg PO every 4 hours as needed.

      Subjects in both groups will receive baseline ASES Shoulder Score assessments before the
      block and procedure, and again in postoperative days 1-7. Additionally, a daily MBPI Short
      Form will be adminstered for the seven days post operation. The primary endpoint is to assess
      the median pain score on POD 1 using the MBPI Short form. Secondary endpoints include
      Cumulative Area Under Curve (AUC) median pain score on POD1-3, opioid consumption through
      POD3, satisfaction with pain treatment, block duration, success rate, amount of
      analgesia/sedation used for it; and adverse effects attributed to either the block or
      catheter, and functionality of the surgical arm.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A randomized prospective noninferiority trial to assess the difference, if any, in median pain scores between two block methods using bupivacaine HCl and/or Liposomal bupivacaine, with the catheter method or single shot administration.
primary purpose: Prevention
masking: None (Open Label)
measure: Median pain score on POD1
time frame: 24 hours
description: Median pain score on POD1 as measured by the MBPI Short Form
measure: Cumulative Area under Curve median pain score on POD1-3
time frame: 72 hours
description: Median pain score on POD1-3 as measured by the MBPI Short Form
arm group label: Bupivacaine HCl/Bupivacaine CISB
arm group type: Active Comparator
description: 23 patients will be enrolled to receive a single-injection bupivacaine HCL interscalene block with bupivacaine CISB added.
arm group label: Liposomal Bupivacaine Added to Interscalene Block
arm group type: Experimental
description: 23 patients will be enrolled to receive a single-injection bupivacaine HCl interscalene block with liposomal bupivacaine added to same injection.
intervention type: Procedure
intervention name: Single-injection bupivacaine HCl plus liposomal bupivacaine
description: Patients in the liposomal bupivacaine with added bupivacaine HCl ISB group will be given a single injection LB ISB in the preoperative area only by faculty who are part of the regional anesthesia division. The injectate will include liposomal bupivacaine 10ml (133mg) mixed with bupivacaine HCl 0.5% 10 ml.
arm group label: Liposomal Bupivacaine Added to Interscalene Block
intervention type: Procedure
intervention name: Single-injection bupivacaine HCl plus a subsequent bupivacaine CISB
description: Patients in the bupivacaine CISB group will undergo catheter placement with ultrasound guidance only by faculty who are part of the regional anesthesia division. A 20 mL single bolus ISB with 0.25% bupivacaine will be administered followed by catheter infusion of 0.125% bupivacaine at a rate of 5mL/hour postoperatively by the ON-Q pump
arm group label: Bupivacaine HCl/Bupivacaine CISB
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Anthony T Machi, MD
role: Principal Investigator
affiliation: UT Southwestern Medical Center
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Texas Southwestern Medical Center
investigator full name: Anthony Machi
investigator title: Assistant Professor
mesh term: Shoulder Pain
mesh term: Bupivacaine
sharing ipd: No
ipd description: No study data will be shared with outside entities or non-IRB approved study personnel.