Title
A Prospective Study to Compare Bupivacaine and Exparel Versus Bupivacaine or Exparel Alone for Postoperative Pain Relief
Combined Administration of Bupivacaine and Exparel Versus Bupivacaine or Exparel Alone for Postoperative Analgesia in Posterior Lumbar Spine Surgery - A Prospective Randomized Study
Phase
Phase 4Lead Sponsor
Virtua Health, Inc.Study Type
InterventionalStatus
Terminated Results PostedIntervention/Treatment
Exparel BupivacaineStudy Participants
19The 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.
1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL
30 mL bupivacaine 0.5% w/v solution
Inclusion Criteria: Age 18 or older; Primary indication is low back pain, lumbosacral radiculopathy, lumbar disc degeneration, lumbar disc herniation, stenosis, spondylolisthesis, spondylolysis, or deformity requiring surgical intervention; Scheduled to undergo primary, 1 or 2 level, posterior lumbar laminectomy with or without fusion, discectomy with fusion, or fusion at Virtua Memorial Hospital; Willing to provide informed consent, participate in study, and comply with study protocol. Exclusion Criteria: Hypersensitivity or allergy to local anesthetics; Pregnant or contemplating pregnancy prior to surgery; Previous surgery in lumbar spine (i.e. other than microdiscectomy); Prior treatment for alcohol, recreational drug, or opioid abuse; Serious spinal conditions (e.g. spinal cord compression, cauda equina syndrome, spinal infection, spinal tumor, spinal fracture, inflammatory or systemic spinal arthritis); Surgery involving more than 2 vertebral levels; 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). Lactating women Patients with end stage liver disease
| Event Type | Organ System | Event Term | Local Infiltration of EXPAREL and Bupivacaine | Local Infiltration of Exparel | Local Infiltration of Bupivacaine |
|---|
Wong-Baker pain faces scale of 0-no pain, to 10-extreme pain
All opioid analgesics will be converted into oral mg morphine equivalent to determine the total dose of opioids
Mean time to achieve physical therapy discharge criteria
Number of Participants with Opioid Related Adverse Events
