Total Knee Arthroplasty: 16 US centers
Study Methods
- 139 patients who received a TKA, with 70 receiving EXPAREL and 69 who did not
- Phase 4 clinical trial
Safety Outcomes
- Both treatments were well tolerated, with most adverse events mild or moderate. One patient in each group experienced a serious adverse event, with both events deemed unrelated to the study medication
Clinical and Economic Outcomes
In patients who received EXPAREL for analgesia
Significantly
better pain control
(P=0.0381)
12 to 48 hours
after surgery*78%
reduction in opioid
use 0 to 48 hours
after surgery
(P=0.0048)†10%
of patients
free of opioids
at 72 hours
(P<0.01)‡
TKA (N=139)
- Preoperative regimen
- Acetaminophen 1000 mg, celecoxib 200 mg, oral pregabalin 300 mg, and intravenous tranexamic acid 1 g within 4 hours before surgery
- Intraoperative regimen
- Fentanyl or its analog
- Postsurgical regimen
- Oral acetaminophen 975 to 1000 mg every 8 hours, oral celecoxib 200 mg every 12 hours, rescue analgesics as needed (oral immediate-release oxycodone ≤10 mg every 4 hours or as needed, 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 medications were received upon patient request for analgesia
TKA WITH EXPAREL (n=70)
- Local infiltration with EXPAREL 266 mg/20 mL admixed with bupivacaine HCl 0.5%, 20 mL, expanded with saline to a total volume of 120 mL
TKA WITHOUT EXPAREL (n=69)
- Local infiltration with bupivacaine HCl 0.5%, 20 mL, expanded with saline to a total volume of 120 mL
*Pain measured using visual analog scale.
†The clinical benefit of the decrease in opioid consumption was not demonstrated in the clinical trials.
‡Compared with 0% of patients who received bupivacaine HCl alone.
TKA, total knee arthroplasty.