A Prospective Study to Compare Bupivacaine and Exparel Versus Bupivacaine or Exparel Alone for Postoperative Pain Relief
Stopped early · Phase 4
Conditions studied: Low Back Pain, Lumbosacral Radiculopathy, Lumbar Disc Degeneration, Lumbar Disc Herniation, Stenosis, Spondylolisthesis, Spondylolysis, Deformity of Spine
In brief
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.
Key facts
- Study ID
- NCT03514277
- Run by
- Virtua Health, Inc.
- People needed
- 19
- Starts
- 2016-12-01
- Expected to finish
- 2019-12-31
- Last updated by the study team
- 2021-01-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Age 18 or older;
- Primary indication is low back pain, lumbosacral radiculopathy, lumbar disc degeneration, lumbar disc herniation, stenosis, spondylolisthesis, spondylolysis, or deformity requiring surgical intervention;
- Scheduled to undergo primary, 1 or 2 level, posterior lumbar laminectomy with or without fusion, discectomy with fusion, or fusion at Virtua Memorial Hospital;
- Willing to provide informed consent, participate in study, and comply with study protocol.
You may not qualify if…
- Hypersensitivity or allergy to local anesthetics;
- Pregnant or contemplating pregnancy prior to surgery;
- Previous surgery in lumbar spine (i.e. other than microdiscectomy);
- Prior treatment for alcohol, recreational drug, or opioid abuse;
- Serious spinal conditions (e.g. spinal cord compression, cauda equina syndrome, spinal infection, spinal tumor, spinal fracture, inflammatory or systemic spinal arthritis);
- Surgery involving more than 2 vertebral levels;
- Worker's compensation or personal injury related to lumbar spine (treatment outcomes may be affected by patient's personal interests [21]; could also run into potential issues with reimbursement).
- Lactating women
- Patients with end stage liver disease
Where it is running
- Virtua Memorial Hospital — Mount Holly, New Jersey, United States
Full record on ClinicalTrials.gov
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