A Prospective Study to Compare Bupivacaine and Exparel Versus Bupivacaine or Exparel Alone for Postoperative Pain Relief
Description
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.
Study Start Date
December, 01 2016
Estimated Completion Date
December 2019
Interventions
- Drug: Exparel
- Drug: Bupivacaine
Study ID
Virtua Health, Inc. -- VirtuaHealthExparel
Status
Unknown
Trial ID
Study Type
Interventional
Trial Phase
Phase 4
Enrollment Quota
135
Sponsor
Virtua Health, Inc.
Inclusion Criteria
-
1. Age 18 or older
2. Primary indication is low back pain, lumbosacral radiculopathy, lumbar disc
degeneration, lumbar disc herniation, stenosis, spondylolisthesis, spondylolysis, or
deformity requiring surgical intervention
3. Scheduled to undergo primary, 1 or 2 level, posterior lumbar laminectomy with or
without fusion, discectomy with fusion, or fusion at Virtua Memorial Hospital
4. Willing to provide informed consent, participate in study, and comply with study
protocol.
Exclusion Criteria
-
1. Hypersensitivity or allergy to local anesthetics
2. Pregnant or contemplating pregnancy prior to surgery
3. Previous surgery in lumbar spine (i.e. other than microdiscectomy)
4. Prior treatment for alcohol, recreational drug, or opioid abuse
5. Serious spinal conditions (e.g. spinal cord compression, cauda equina syndrome, spinal
infection, spinal tumor, spinal fracture, inflammatory or systemic spinal arthritis)
6. Surgery involving more than 2 vertebral levels
7. 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).
8. Lactating women
9. Patients with end stage liver disease
Gender
All
Ages
18 Years and older
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Study Locations and Contact Information (1)
Study Location | Distance | Name | Phone | |
---|---|---|---|---|
Virtua Memorial Hospital - Mount Holly, New Jersey | 118.0 miles | Robert Greenleaf MD | 609-267-9400 | bob.greenleaf1@gmail.com |