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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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 Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03514277
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	Phase 4
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Virtua Health, Inc.
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Robert Greenleaf, MD
Principal Investigator Affiliation	Princpal Investigator
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Low Back Pain, Lumbosacral Radiculopathy, Lumbar Disc Degeneration, Lumbar Disc Herniation, Stenosis, Spondylolisthesis, Spondylolysis, Deformity of Spine

Arms & Interventions

Arms

Active Comparator: Local infiltration of EXPAREL and Bupivacaine

Active Comparator: Local infiltration of Exparel

Active Comparator: Local infiltration of Bupivacaine

Interventions

Drug: - Exparel

1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL

Drug: - Bupivacaine

30 mL bupivacaine 0.5% w/v solution

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Virtua Memorial Hospital, Mount Holly, New Jersey

Status

Recruiting

Address

Virtua Memorial Hospital

Mount Holly, New Jersey, 08060

Site Contact

Robert Greenleaf, MD

[email protected]

609-267-9400

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