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

NCT03514277 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: VirtuaHealthExparel
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• 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

Study Arms (3)

Local infiltration of EXPAREL and Bupivacaine

ACTIVE COMPARATOR

Drug: Exparel; Drug: Bupivacaine

Local infiltration of Exparel

ACTIVE COMPARATOR

Drug: Exparel

Local infiltration of Bupivacaine

ACTIVE COMPARATOR

Drug: Bupivacaine

Interventions

Exparel DRUG

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

Local infiltration of EXPAREL and Bupivacaine; Local infiltration of Exparel

Bupivacaine DRUG

30 mL bupivacaine 0.5% w/v solution

Local infiltration of Bupivacaine; Local infiltration of EXPAREL and Bupivacaine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 or older;
• Primary indication is low back pain, lumbosacral radiculopathy, lumbar disc degeneration, lumbar disc herniation, stenosis, spondylolisthesis, spondylolysis, or deformity requiring surgical intervention;
• Scheduled to undergo primary, 1 or 2 level, posterior lumbar laminectomy with or without fusion, discectomy with fusion, or fusion at Virtua Memorial Hospital;
• Willing to provide informed consent, participate in study, and comply with study protocol.

You may not qualify if:

• Hypersensitivity or allergy to local anesthetics;
• Pregnant or contemplating pregnancy prior to surgery;
• Previous surgery in lumbar spine (i.e. other than microdiscectomy);
• Prior treatment for alcohol, recreational drug, or opioid abuse;
• Serious spinal conditions (e.g. spinal cord compression, cauda equina syndrome, spinal infection, spinal tumor, spinal fracture, inflammatory or systemic spinal arthritis);
• Surgery involving more than 2 vertebral levels;
• 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).
• Lactating women
• Patients with end stage liver disease

Sponsors & Collaborators

• Virtua Health, Inc.: lead

Study Sites (1)

Virtua Memorial Hospital

Mount Holly, New Jersey, 08060, United States

Location

MeSH Terms

Conditions

Low Back Pain; Intervertebral Disc Degeneration; Intervertebral Disc Displacement; Constriction, Pathologic; Spondylolisthesis; Spondylolysis

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Spondylosis

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed

Results Point of Contact

• Title: Robert Greenleaf
• Organization: Reconstructive Orthopedics

bob.greenleaf1@gmail.com

609-267-9400

Study Officials

• Robert Greenleaf, MD

  Princpal Investigator

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2018
• First Posted: May 2, 2018
• Study Start: December 1, 2016
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: January 6, 2021
• Results First Posted: January 6, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)