Clinical trial NCT03514277: A Prospective Study to Compare Bupivacaine and Exparel Versus Bupivacaine or Exparel Alone for Postoperative Pain Relief
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Low Back Pain
Lumbosacral Radiculopathy
Lumbar Disc Degeneration
Lumbar Disc Herniation
Stenosis
Spondylolisthesis
Spondylolysis
Deformity of Spine
Lead sponsor: Virtua Health, Inc.
Sponsor class: OTHER
First posted: 2018-05-02
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Mean Postoperative Pain Score
timeFrame: last day of hospitalization, average of 3 days in hospital
Secondary outcomes:
measure: Total Consumption of Opioids During Hospital Stay
timeFrame: last day of hospitalization, average of 3 days in hospital
measure: Mean Time to Achieve Physical Therapy Discharge
timeFrame: last day of hospitalization, average of 3 days in hospital
measure: Number of Participants With Opioid Related Adverse Events
timeFrame: last day of hospitalization, average of 3 days in hospital
Other outcomes:
Locations:
city: Mount Holly
country: United States
facility: Virtua Memorial Hospital
state: New Jersey
Study officials:
affiliation: Princpal Investigator
name: Robert Greenleaf, MD
role: PRINCIPAL_INVESTIGATOR
References: