Clinical trial NCT03913091: 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)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Shoulder Pain
Keywords: Total Shoulder Arthroplasty (TSA)
Interscalene Nerve Block (ISB)
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2019-04-12
Enrollment: 184
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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;
* 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

Primary outcomes:
measure: Opioid Utilization
timeFrame: 24-72 hour, Post-Operative Period
Secondary outcomes:
measure: Opioid Utilization
timeFrame: Day 4-7, Post-Operative Period
measure: Score on Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Scale
timeFrame: Day 1-7, Post-Operative Period
measure: T-Scores, PROMIS Pain Intensity Scale
timeFrame: Day 1-7, Post-Operative Period
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: New York Langone Medical Center
name: Uchenna Umeh, MD
role: PRINCIPAL_INVESTIGATOR
References: