Phase 4 Study in Adult Subjects Undergoing Posterior Lumbar Spine Surgeries

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.

Timeline

Start

2019-07-31

Primary completion

2020-08-04

Completion

2020-08-04

Outcome

Outcome not reported

Stopped: “Due to protocol feasibility given the rapid evolution of medical practice for spinal procedure. Data from approximately 65 FUSION study subjects will be analyzed with the intent to create either a future study or registry for this patient population.”

Drugs

Indications

No indication recorded.