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)
Overview
- Phase
- Phase 4
- Intervention
- 0.5% Bupivacaine HCL
- Conditions
- Shoulder Pain
- Sponsor
- NYU Langone Health
- Enrollment
- 184
- Locations
- 1
- Primary Endpoint
- Opioid Utilization
- Status
- Completed
- Last Updated
- 4 years ago
Overview
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.
Investigators
Eligibility 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;
Arms & Interventions
20 mL 0.5% Bupivacaine HCL
Intervention: 0.5% Bupivacaine HCL
Interscalene nerve block with Liposomal + Bupivacaine 0.5%
Administered in an Interscalene block for TSA
Intervention: Liposomal Bupivacaine
Outcomes
Primary Outcomes
Opioid Utilization
Time Frame: 24-72 hour, Post-Operative Period
Measure in morphine milligram equivalents \[MME\]
Secondary Outcomes
- Opioid Utilization(Day 4-7, Post-Operative Period)
- Score on Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Scale(Day 1-7, Post-Operative Period)
- T-Scores, PROMIS Pain Intensity Scale(Day 1-7, Post-Operative Period)