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

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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

NCT03514277

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

Study Locations and Contact Information (1)

Study Location	Distance	Name	Phone	Email
Virtua Memorial Hospital - Mount Holly, New Jersey	118.0 miles	Robert Greenleaf MD	609-267-9400	bob.greenleaf1@gmail.com

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