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



Status:Recruiting
Conditions:Back Pain, Back Pain, Neurology, Orthopedic
Therapuetic Areas:Musculoskeletal, Neurology, Orthopedics / Podiatry
Healthy:No
Age Range:18 - Any
Updated:4/3/2019
Start Date:December 1, 2016
End Date:December 31, 2019
Contact:Robert Greenleaf, MD
Email:bob.greenleaf1@gmail.com
Phone:609-267-9400

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

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.


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
We found this trial at
1
site
175 Madison Avenue
Mount Holly, New Jersey 08060
Principal Investigator: Robert Greenleaf, MD
Phone: 609-267-9400
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from
Mount Holly, NJ
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