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

V

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

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

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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