Total Shoulder Arthroplasty or Rotator Cuff Repair: 16 international study sites
Study Methods
- 140 patients undergoing TSA or RCR who received EXPAREL (n=69) or placebo (n=71)
- Phase 3 clinical trial
Safety Outcomes
- 4 patients (3 in the EXPAREL group and 1 in the placebo group) experienced adverse events that were deemed unrelated to the study medication
Clinical and Economic Outcomes
In patients who received EXPAREL for analgesia
Significantly
better pain control
(P<0.0001)
through 48 hours
after surgery- Median time to return of sensory function with EXPAREL was 36 hours, which was significantly longer than placebo (P<0.0001), and median time to return of motor function was 24 hours with both EXPAREL and placebo
78%
reduction in opioid
use through 48 hours
(P<0.0001)*13%
of patients opioid free compared with 1% with placebo at 48 hours
(P=0.008)
TSA OR RCR
- Preoperative regimen
- Low-dose aspirin for cardioprotection and oral or intravenous acetaminophen 1000 mg every 8 hours
- Patients randomized 1:1:1 to EXPAREL 266 mg, EXPAREL 133 mg, or matching placebo (20 mL total volume for each). Randomization to EXPAREL 266 mg stopped after sufficient patients (n=15) were selected for pharmacokinetic assessment
- Postsurgical regimen
- Rescue medication only given based on patient request
- Oral immediate-release oxycodone ≤10 mg every 4 hours or as needed and intravenous morphine 2.5 to 5 mg or hydromorphone 0.5 to 1 mg every 4 hours or as needed if oral medication was not tolerated
- Rescue medication only given based on patient request
*The clinical benefit of the decrease in opioid consumption was not demonstrated in the clinical trials.
RCR, rotator cuff repair; TSA, total shoulder arthroplasty.
ASP, average sales price; CMS, Centers for Medicare and Medicaid Services.