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

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ClinicalTrials.gov Identifier: NCT03514277
Recruitment Status : Recruiting
First Posted : May 2, 2018
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
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.

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 135 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
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Mean postoperative pain score [ Time Frame: 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: 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 criteria [ Time Frame: Average of 3 days in hospital ]
  3. Incidence of opioid related adverse events [ Time Frame: Average of 3 days in hospital ]


Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514277


Contacts
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Contact: Robert Greenleaf, MD 609-267-9400 bob.greenleaf1@gmail.com

Locations
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United States, New Jersey
Virtua Memorial Hospital Recruiting
Mount Holly, New Jersey, United States, 08060
Contact: Robert Greenleaf, MD    609-267-9400    bob.greenleaf1@gmail.com   
Principal Investigator: Robert Greenleaf, MD         
Sponsors and Collaborators
Virtua Health, Inc.
Investigators
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Principal Investigator: Robert Greenleaf, MD Princpal Investigator

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Responsible Party: Virtua Health, Inc.
ClinicalTrials.gov Identifier: NCT03514277     History of Changes
Other Study ID Numbers: VirtuaHealthExparel
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Publish research findings in relevant peer-reviewed journal

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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:
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Spondylolisthesis
Intervertebral Disc Degeneration
Spondylolysis
Radiculopathy
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms
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