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

Phase 4

Terminated

• Conditions: Lumbar Disc Degeneration; Deformity of Spine; Spondylolysis; Lumbosacral Radiculopathy; Low Back Pain; Stenosis; Lumbar Disc Herniation; Spondylolisthesis
• Interventions: Drug: Bupivacaine; Drug: Exparel

• Registration Number: NCT03514277
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-12-01
• Study First Submitted: 2018-03-15
• Study First Submitted QC: 2018-05-01
• Study First Posted: 2018-05-02
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Results First Submitted: 2020-11-06
• Status Verified: 2020-12
• Results First Submitted QC: 2020-12-10
• Last Update Submitted: 2020-12-10
• Results First Posted: 2021-01-06
• Last Update Posted: 2021-01-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 19

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Local infiltration of Bupivacaine	Bupivacaine	-
Local infiltration of EXPAREL and Bupivacaine	Exparel	-
Local infiltration of Exparel	Exparel	-
Local infiltration of EXPAREL and Bupivacaine	Bupivacaine	-

Primary Outcome Measures

Name	Time	Method
Mean Postoperative Pain Score	last day of hospitalization, average of 3 days in hospital	Wong-Baker pain faces scale of 0-no pain, to 10-extreme pain

Secondary Outcome Measures

Name	Time	Method
Mean Time to Achieve Physical Therapy Discharge	last day of hospitalization, average of 3 days in hospital	Mean time to achieve physical therapy discharge criteria
Total Consumption of Opioids During Hospital Stay	last day of hospitalization, average of 3 days in hospital	All opioid analgesics will be converted into oral mg morphine equivalent to determine the total dose of opioids
Number of Participants With Opioid Related Adverse Events	last day of hospitalization, average of 3 days in hospital	Number of Participants with Opioid Related Adverse Events

Trial Locations

Locations (1)

Virtua Memorial Hospital; 🇺🇸 Mount Holly, New Jersey, United States