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

Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03514277
• Other study ID #: VirtuaHealthExparel
• Status: Terminated
• Phase: Phase 4
• Start date: December 1, 2016
• Est. completion date: December 31, 2019

Study information

• Verified date: December 2020
• Source: Virtua Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deformity of Spine
• Intervertebral Disc Degeneration
• Low Back Pain
• Lumbar Disc Degeneration
• Lumbar Disc Herniation
• Lumbosacral Radiculopathy
• Radiculopathy
• Spondylolisthesis
• Spondylolysis
• Stenosis

Intervention

Drug:
• Exparel
1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL
• Bupivacaine
30 mL bupivacaine 0.5% w/v solution

Locations

Country	Name	City	State
United States	Virtua Memorial Hospital	Mount Holly	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Virtua Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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