Phase 4 Study in Adult Subjects Undergoing Posterior Lumbar Spine Surgeries
Status:
Terminated
Trial end date:
2020-08-04
Target enrollment:
Participant gender:
Summary
Primary Objective: The primary objective of this study is to compare postsurgical opioid
consumption through 72 hours postsurgery in patients receiving local infiltration analgesia
(LIA) with EXPAREL and bupivacaine HCl (EXPAREL group) with that of patients receiving
standard of care (SOC) (control group) in adult subjects undergoing posterior lumbar spine
surgeries where both groups are receiving a multimodal pain regimen.
Secondary Objectives: The secondary objectives of this study are to:
1. Compare safety and effectiveness outcomes following LIA with EXPAREL and bupivacaine
hydrochloride (HCl) versus SOC in adult subjects undergoing posterior lumbar spine
surgeries through 72 hours, including time to first opioid and opioid-related adverse
events (ORAEs).
2. Compare health outcomes following LIA with EXPAREL and bupivacaine hydrochloride (HCl)
versus SOC in adult subjects undergoing posterior lumbar spine surgeries, including
discharge readiness, hospital (or other facility) length of stay (LOS), discharge
disposition, hospital readmissions, and health service utilization.