This is a Phase 3, multicenter, randomized, double blinded, active controlled study in approximately 120 subjects undergoing lower extremity surgeries.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
121
EXPAREL (bupivacaine liposome injectable suspension)
0.25% bupivacaine
Arizona Research Center
Phoenix, Arizona, United States
Lotus Clinical Research
Pasadena, California, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, United States
HD Research, Corp
Bellaire, Texas, United States
Magnitude of the Analgesic Effect (NRS Pain Intensity) (AUC)
To compare the magnitude of the analgesic effect (NRS pain intensity scores) following a single dose injection of EXPAREL vs. bupivacaine hydrochloride (HCl) when administered as combined sciatic (in the popliteal fossa) and saphenous (in the adductor canal) nerve blocks in subjects undergoing lower extremity surgeries. Numerical Rating Scale: an 11 point scale 0=no pain, 10= the worst pain imaginable. The area under the curve (AUC) of the NRS pain intensity scores from 0 to 96 hours post-surgery comparing EXPAREL to 0.25% bupivacaine HCl
Time frame: Post surgery - 96 hours
Total Opioid Consumption
Total Opioid Consumption in oral morphine equivalents
Time frame: 0 hours to 96 hours
Time to First Opioid
Time to First Opioid following a single dose of EXPAREL vs. Bupivacain HCl
Time frame: Post Surgery through Day 14
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