Low Back Pain Clinical Trial
Official title:
Combined Administration of Bupivacaine and Exparel Versus Bupivacaine or Exparel Alone for Postoperative Analgesia in Posterior Lumbar Spine Surgery - A Prospective Randomized Study
Verified date | December 2020 |
Source | Virtua Health, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 19 |
Est. completion date | December 31, 2019 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Virtua Memorial Hospital | Mount Holly | New Jersey |
Lead Sponsor | Collaborator |
---|---|
Virtua Health, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Mean Postoperative Pain Score | Wong-Baker pain faces scale of 0-no pain, to 10-extreme pain | last day of hospitalization, average of 3 days in hospital | |
Secondary | Total Consumption of Opioids During Hospital Stay | All opioid analgesics will be converted into oral mg morphine equivalent to determine the total dose of opioids | last day of hospitalization, average of 3 days in hospital | |
Secondary | Mean Time to Achieve Physical Therapy Discharge | Mean time to achieve physical therapy discharge criteria | last day of hospitalization, average of 3 days in hospital | |
Secondary | Number of Participants With Opioid Related Adverse Events | Number of Participants with Opioid Related Adverse Events | last day of hospitalization, average of 3 days in hospital |
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