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

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.

Study Overview

• Status: Terminated
• Conditions: Low Back Pain; Lumbar Disc Herniation; Spondylolisthesis; Spondylolysis; Lumbar Disc Degeneration; Stenosis; Deformity of Spine; Lumbosacral Radiculopathy
• Intervention / Treatment: Drug: Exparel; Drug: Bupivacaine

• Study Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Mount Holly, New Jersey, United States, 08060
      • Virtua Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Virtua Health, Inc.
• Investigators: Principal Investigator: Robert Greenleaf, MD, Princpal Investigator

Study record dates

Study Major Dates

• Study Start (ACTUAL): December 1, 2016
• Primary Completion (ACTUAL): December 31, 2019
• Study Completion (ACTUAL): December 31, 2019

Study Registration Dates

• First Submitted: March 15, 2018
• First Submitted That Met QC Criteria: May 1, 2018
• First Posted (ACTUAL): May 2, 2018

Study Record Updates

• Last Update Posted (ACTUAL): January 6, 2021
• Last Update Submitted That Met QC Criteria: December 10, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Back Pain; Spondylosis; Low Back Pain; Intervertebral Disc Displacement; Intervertebral Disc Degeneration; Radiculopathy; Spondylolisthesis; Spondylolysis; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Bupivacaine
• Other Study ID Numbers: VirtuaHealthExparel

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Publish research findings in relevant peer-reviewed journal

Drug and device information, study documents

• 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