Unilateral, Single-Level Transforaminal Lumbar Interbody Fusion:
Medical center in Massachusetts
Study Methods
- 37 adult patients undergoing unilateral, single-level TLIF with EXPAREL compared with a historic control for the same procedure (N=74)
- Retrospective, observational study matched 1:1 to controls
- Surgical and treatment protocol was the same for both groups. In the EXPAREL group, EXPAREL was infiltrated at the conclusion of surgery in addition to the standard, nonliposomal local anesthetic received by the control group
- Cost was analyzed from the hospital perspective and savings per procedure were determined by the mean total costs for patients in both groups
- Means and standard deviations were analyzed for all presurgical and postsurgical outcomes
Safety Outcomes
- The overall rate of complications was identical in both groups (8.1%)
- No adverse events were attributed to the use of EXPAREL
Clinical and Economic Outcomes
Patients who received ERP with EXPAREL to manage pain after surgery had
Significantly
better pain control
reported in the
first 24 hours*- 0 to 12 hours: 15.0 vs 45.6 (P=0.003)
- 12 to 24 hours: 37.6 vs 48.4 (P=0.05)
34%
fewer opioids
used at 12 to
24 hours†‡- 12 to 24 hours: 16.0 vs 24.1 (P=0.04)
1.2 Days
shorter LOS
- 3.1 vs 4.3 days (P<0.001)
$590
lower mean total
per-patient cost- $14,816 vs $15,406
ERP ALONE (n=37)
- Standard postsurgical treatment protocol
- Acetaminophen
- Oral and intravenous narcotics
- Oxycodone or hydromorphone
- Muscle relaxants
- Cyclobenzaprine, diazepam, or tizanidine
- Received an intraoperative injection of lidocaine or bupivacaine hydrochloride
ERP WITH EXPAREL (n=37)
- Identical ERP as in ERP-alone group
- Local infiltration into the surgical site with EXPAREL expanded with saline and bupivacaine hydrochloride
*Pain was self-reported by patients using the visual analog scale. Scores recorded over the first 3 days were divided into 12-hour intervals and used to calculate the area under the curve.
†Opioid consumption was measured using intravenous morphine milligram equivalent.
‡The clinical benefit of the decrease in opioid consumption was not demonstrated in the clinical trials.
TLIF, transforaminal lumbar interbody fusion; ERP, enhanced recovery protocol; LOS, length of stay.
ASP, average sales price; CMS, Centers for Medicare and Medicaid Services.