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Liposomal Bupivacaine (Exparel ® ) Plus 0.5% Bupivacaine HCL Versus 0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB) for Patients Undergoing Total Shoulder Arthroplasty(TSA)

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ClinicalTrials.gov Identifier: NCT03913091
Recruitment Status : Recruiting
First Posted : April 12, 2019
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Brief Summary:
This is a phase IV , randomized, single-blind, single-center study comparing patient related outcomes such as postoperative pain and opioid usage for patients who receive ISB 's containing liposomal bupivacaine (Exparel®) plus 0.5% bupivacaine HCL versus 0.5% bupivacaine HCL undergoing total shoulder arthroplasty. The objective of this study is to compare opioid utilization and pain management of patients who receive Exparel in an ISB vs standard 0.5% bupivacaine HCL during the initial 72 --‐ hour post --‐ operative period. Additionally, to understand the duration of block after addition of Exparel® to bupivacaine in an Interscalene block after TSA.

Condition or disease Intervention/treatment Phase
Shoulder Pain Drug: Liposomal Bupivacaine Drug: 0.5% Bupivacaine HCL Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 184 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Liposomal Bupivacaine (Exparel ® ) Plus 0.5% Bupivacaine HCL Versus 0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB) for Patients Undergoing Total Shoulder Arthroplasty(TSA)
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : March 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 20 mL 0.5% Bupivacaine HCL Drug: 0.5% Bupivacaine HCL
0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB)

Experimental: Interscalene nerve block with Liposomal + Bupivacaine 0.5%
Administered in an Interscalene block for TSA
Drug: Liposomal Bupivacaine
Liposomal Bupivacaine Plus 0.5% Bupivacaine HCL
Other Name: Exparel




Primary Outcome Measures :
  1. Opiod Utilization [ Time Frame: 72 Post Operative Period ]
    Measure in morphine milligram equivalents [MME]


Secondary Outcome Measures :
  1. VAS Pain Scores [ Time Frame: Day 7 Post Operative Period ]
    Patient reported pain intensity assessment. Patients will be asked 3 questions, with a range of scores of 1-"Had no pain" to 5- "Very Severe."



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients undergoing total shoulder arthroplasty;
  • Patients who consent to be randomized.

Exclusion Criteria:

  • Patients younger than 18 and older than 75;
  • Patients with a history of chronic pain that have used opioids for pain management for 3 months or longer;
  • Patients who are allergic to oxycodone;
  • Patients who are unable to speak English;
  • Patients with diagnosed or self--‐reported cognitive dysfunction;
  • Patients with a history of neurologic disorder that can interfere with pain sensation;
  • Patients with a history of drug or recorded alcohol abuse;
  • Patients who are unable to understand or follow instructions;
  • Patients with severe liver disease, renal insufficiency, congestive heart failure, and/or significant heart disease;
  • Patients with an allergy or contraindication to any of the medications used in the study, or patients with a contraindication to any study procedures;
  • Patients with BMI over 40;
  • Any patient that the investigators feel cannot comply with all study related procedures;
  • NYU Langone Health students, residents, faculty or staff members

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03913091


Contacts
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Contact: Randy Cuevas 212 598 6085 Randy.Cuevas@nyulangone.org

Locations
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United States, New York
NYU Langone Health Recruiting
New York, New York, United States, 10016
Contact: Randy Cuevas    212-598-6085    Randy.Cuevas@nyulangone.org   
Principal Investigator: Uchenna Umeh, MD         
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Uchenna Umeh, MD New York Langone Medical Center

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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT03913091    
Other Study ID Numbers: 18-01183
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices). Data will be available to achieve aims in the approved proposal.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: Immediately following publication. No end date
Access Criteria:

Requests should be directed to uchenna.umeh@nyulangone.org. To gain access, data requestors will need to sign a data access agreement.

Access will be given to researchers who provide a methodologically sound proposal and investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose.


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by NYU Langone Health:
Total Shoulder Arthroplasty (TSA)
Interscalene Nerve Block (ISB)
Additional relevant MeSH terms:
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Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents