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

Sponsors

Lead Sponsor: Virtua Health, Inc.

Source Virtua Health, Inc.
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.

Overall Status Terminated
Start Date 2016-12-01
Completion Date 2019-12-31
Primary Completion Date 2019-12-31
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Mean Postoperative Pain Score last day of hospitalization, average of 3 days in hospital
Secondary Outcome
Measure Time Frame
Total Consumption of Opioids During Hospital Stay last day of hospitalization, average of 3 days in hospital
Mean Time to Achieve Physical Therapy Discharge last day of hospitalization, average of 3 days in hospital
Number of Participants With Opioid Related Adverse Events last day of hospitalization, average of 3 days in hospital
Enrollment 19
Condition
Intervention

Intervention Type: Drug

Intervention Name: Exparel

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

Intervention Type: Drug

Intervention Name: Bupivacaine

Description: 30 mL bupivacaine 0.5% w/v solution

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Robert Greenleaf, MD Principal Investigator Princpal Investigator
Location
Facility: Virtua Memorial Hospital
Location Countries

United States

Verification Date

2020-12-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 3
Arm Group

Label: Local infiltration of EXPAREL and Bupivacaine

Type: Active Comparator

Label: Local infiltration of Exparel

Type: Active Comparator

Label: Local infiltration of Bupivacaine

Type: Active Comparator

Patient Data No
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Basic Science

Masking: Double (Participant, Care Provider)

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