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

Study Overview
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Brief Summary
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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.

Official Title
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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

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

Intervention / Treatment
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* Drug: Exparel
* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Local infiltration of EXPAREL and Bupivacaine<br> | Drug: Exparel<br>* 1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL<br>Drug: Bupivacaine<br>* 30 mL bupivacaine 0.5% w/v solution<br>|
| Active Comparator: Local infiltration of Exparel<br> | Drug: Exparel<br>* 1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL<br>|
| Active Comparator: Local infiltration of Bupivacaine<br> | Drug: Bupivacaine<br>* 30 mL bupivacaine 0.5% w/v solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 |