Phase 4
Completed N=184
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)
Source: ClinicalTrials.gov NCT03913091 ↗Enrolled (actual)
184
Serious AEs
0.0%
Results posted
Feb 2022
Primary outcomePrimary: Opioid Utilization — 54.79; 30.38 Morphine Milligram Equivalents (MME)
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Opioid Utilization |
36.44; 18.73 | — |
| SECONDARY Opioid Utilization |
36.44; 18.73 | — |
| SECONDARY Score on Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Scale |
3.7; 3.07; 2.81; 2.39; 2.22; 1.83 | — |
| SECONDARY T-Scores, PROMIS Pain Intensity Scale |
46.48; 50.8 | — |
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
Data sourced from ClinicalTrials.gov (NCT03913091). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.