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

• ClinicalTrials.gov Identifier: NCT03514277
• Recruitment Status: Terminated
• First Posted: May 2, 2018
• Results First Posted: January 6, 2021
• Last Update Posted: January 6, 2021
• Sponsor: Virtua Health, Inc.
• Information provided by (Responsible Party): Virtua Health, Inc.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Low Back Pain; Lumbosacral Radiculopathy; Lumbar Disc Degeneration; Lumbar Disc Herniation; Stenosis; Spondylolisthesis; Spondylolysis; Deformity of Spine	Drug: Exparel; Drug: Bupivacaine	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 19 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Care Provider)
• Primary Purpose: Basic Science
• 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
• Actual Study Start Date: December 1, 2016
• Actual Primary Completion Date: December 31, 2019
• Actual Study Completion Date: December 31, 2019

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Local infiltration of EXPAREL and Bupivacaine	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
Active Comparator: Local infiltration of Exparel	Drug: Exparel; 1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL
Active Comparator: Local infiltration of Bupivacaine	Drug: Bupivacaine; 30 mL bupivacaine 0.5% w/v solution

Outcome Measures

Primary Outcome Measures :

1. Mean Postoperative Pain Score [ Time Frame: 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 :

1. Total Consumption of Opioids During Hospital Stay [ Time Frame: 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
2. Mean Time to Achieve Physical Therapy Discharge [ Time Frame: last day of hospitalization, average of 3 days in hospital ]
   Mean time to achieve physical therapy discharge criteria
3. Number of Participants With Opioid Related Adverse Events [ Time Frame: last day of hospitalization, average of 3 days in hospital ]
   Number of Participants with Opioid Related Adverse Events

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

United States, New Jersey

Virtua Memorial Hospital

Mount Holly, New Jersey, United States, 08060

Sponsors and Collaborators

Virtua Health, Inc.

Investigators

• Principal Investigator: Robert Greenleaf, MD; Princpal Investigator

  Study Documents (Full-Text)

Documents provided by Virtua Health, Inc.:

Study Protocol and Statistical Analysis Plan  [PDF] October 13, 2016

More Information

• Responsible Party: Virtua Health, Inc.
• ClinicalTrials.gov Identifier: NCT03514277
• Other Study ID Numbers: VirtuaHealthExparel
• First Posted: May 2, 2018
• Results First Posted: January 6, 2021
• Last Update Posted: January 6, 2021
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Publish research findings in relevant peer-reviewed journal

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:

Spondylolisthesis; Intervertebral Disc Degeneration; Spondylolysis; Radiculopathy; Low Back Pain; Back Pain; Pain; Neurologic Manifestations; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Spondylosis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Bupivacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents