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)

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Shoulder Pain

Intervention / Treatment
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* Drug: Liposomal Bupivacaine
* Drug: 0.5% Bupivacaine HCL


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 20 mL 0.5% Bupivacaine HCL<br> | Drug: 0.5% Bupivacaine HCL<br>* 0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB)<br>|
| Experimental: Interscalene nerve block with Liposomal + Bupivacaine 0.5%<br>Administered in an Interscalene block for TSA | Drug: Liposomal Bupivacaine<br>* Liposomal Bupivacaine Plus 0.5% Bupivacaine HCL<br>* Other names: Exparel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Utilization | Measure in morphine milligram equivalents [MME] | 24-72 hour, Post-Operative Period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid Utilization | Measure in morphine milligram equivalents [MME] | Day 4-7, Post-Operative Period | 
| Score on Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Scale | PROMIS Pain Intensity surveys are made up of three pain intensity questions, on a scale of 1-5. = No pain = Mild = Moderate = Severe = Very Severe | Day 1-7, Post-Operative Period | 
| T-Scores, PROMIS Pain Intensity Scale | PROMIS Pain Intensity surveys are made up of three pain questions, which generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population. | Day 1-7, Post-Operative Period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Total Shoulder Arthroplasty (TSA), Interscalene Nerve Block (ISB)