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

Virtua Health

Status and phase: Terminated; Phase 4

Conditions: Deformity of Spine; Spondylolisthesis; Lumbar Disc Herniation; Spondylolysis; Lumbosacral Radiculopathy; Stenosis; Low Back Pain; Lumbar Disc Degeneration

Treatments: Drug: Exparel; Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03514277

VirtuaHealthExparel

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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19 participants in 3 patient groups

Local infiltration of EXPAREL and Bupivacaine

Active Comparator group

Treatment:

Drug: Exparel

Drug: Bupivacaine

Local infiltration of Exparel

Active Comparator group

Treatment:

Drug: Exparel

Local infiltration of Bupivacaine

Active Comparator group

Treatment:

Drug: Bupivacaine