NCT03514277

A Prospective Study to Compare Bupivacaine and Exparel Versus Bupivacaine or Exparel Alone for Postoperative Pain Relief

Combined Administration of Bupivacaine and Exparel Versus Bupivacaine or Exparel Alone for Postoperative Analgesia in Posterior Lumbar Spine Surgery - A Prospective Randomized Study

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Virtua Health, Inc. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to collect information about how patients feel when doctors manage their pain after lumbar spine surgery using a combination of EXPAREL® and bupivacaine injected into the lumbar spine at the end of surgery, compared to the patients that doctors use only EXPAREL® or bupivacaine to manage their pain. This information will help doctors determine which approach works best for patients who will receive surgery in their lumbar spine in the future.

Conditions

• Low Back Pain
• Lumbosacral Radiculopathy
• Lumbar Disc Degeneration
• Lumbar Disc Herniation
• Stenosis
• Spondylolisthesis
• Spondylolysis
• Deformity of Spine

Interventions

Type	Name	Description
DRUG	Exparel	1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL
DRUG	Bupivacaine	30 mL bupivacaine 0.5% w/v solution

Timeline

• Start date: 2016-12-01
• Primary completion: 2019-12-31
• Completion: 2019-12-31
• First posted: 2018-05-02
• Last updated: 2021-01-06
• Results posted: 2021-01-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study