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)

NYU Langone Health184 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

184

Conditions

Shoulder Pain

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Opioid Utilization

Measure in morphine milligram equivalents \[MME\]

Time frame: 24-72 hour, Post-Operative Period

Secondary Outcomes

Opioid Utilization

Measure in morphine milligram equivalents \[MME\]

Time frame: 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. 1. = No pain 2. = Mild 3. = Moderate 4. = Severe 5. = Very Severe

Time frame: 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.