Back to resultsA Prospective Study to Compare Bupivacaine and Exparel Versus Bupivacaine or Exparel Alone for Postoperative Pain Relief
Primary Purpose
Low Back Pain, Lumbosacral Radiculopathy, Lumbar Disc Degeneration
Status
Terminated
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Exparel
Bupivacaine
Sponsored by
About this trial
This is an interventional basic science trial for Low Back Pain
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- Virtua Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Local infiltration of EXPAREL and Bupivacaine
Local infiltration of Exparel
Local infiltration of Bupivacaine
Arm Description
Outcomes
Primary Outcome Measures
Mean Postoperative Pain Score
Wong-Baker pain faces scale of 0-no pain, to 10-extreme pain
Secondary Outcome Measures
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
Mean Time to Achieve Physical Therapy Discharge
Mean time to achieve physical therapy discharge criteria
Number of Participants With Opioid Related Adverse Events
Number of Participants with Opioid Related Adverse Events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03514277
Brief Title
A Prospective Study to Compare Bupivacaine and Exparel Versus Bupivacaine or Exparel Alone for Postoperative Pain Relief
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Terminated
Why Stopped
PI decision to close study early
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virtua Health, Inc.
4. Oversight
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
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Lumbosacral Radiculopathy, Lumbar Disc Degeneration, Lumbar Disc Herniation, Stenosis, Spondylolisthesis, Spondylolysis, Deformity of Spine
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Local infiltration of EXPAREL and Bupivacaine
Arm Type
Active Comparator
Arm Title
Local infiltration of Exparel
Arm Type
Active Comparator
Arm Title
Local infiltration of Bupivacaine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Exparel
Intervention Description
1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
30 mL bupivacaine 0.5% w/v solution
Primary Outcome Measure Information:
Title
Mean Postoperative Pain Score
Description
Wong-Baker pain faces scale of 0-no pain, to 10-extreme pain
Time Frame
last day of hospitalization, average of 3 days in hospital
Secondary Outcome Measure Information:
Title
Total Consumption of Opioids During Hospital Stay
Description
All opioid analgesics will be converted into oral mg morphine equivalent to determine the total dose of opioids
Time Frame
last day of hospitalization, average of 3 days in hospital
Title
Mean Time to Achieve Physical Therapy Discharge
Description
Mean time to achieve physical therapy discharge criteria
Time Frame
last day of hospitalization, average of 3 days in hospital
Title
Number of Participants With Opioid Related Adverse Events
Description
Number of Participants with Opioid Related Adverse Events
Time Frame
last day of hospitalization, average of 3 days in hospital
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Greenleaf, MD
Organizational Affiliation
Princpal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virtua Memorial Hospital
City
Mount Holly
State/Province
New Jersey
ZIP/Postal Code
08060
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Publish research findings in relevant peer-reviewed journal
Learn more about this trial
A Prospective Study to Compare Bupivacaine and Exparel Versus Bupivacaine or Exparel Alone for Postoperative Pain Relief
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