Low Back PainPhase 4NCT03514277

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

A Phase 4 study testing Exparel and Bupivacaine in people with Low Back Pain and Lumbosacral Radiculopathy, run by Virtua Health, Inc. at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Low Back Pain, Lumbosacral Radiculopathy, Lumbar Disc Degeneration
What is being tested?: Exparel and Bupivacaine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 19 participants
Where: 1 siteUnited States
Study dates: 1 Dec 2016to 31 Dec 2019
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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;

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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

Trial locations and contacts

1 site in 1 country.

United States1 site

Virtua Memorial Hospital
Mount Holly, New Jersey, 08060

Other trials in United States

About this study

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

Conditions: Low Back Pain, Lumbosacral Radiculopathy, Lumbar Disc Degeneration, Lumbar Disc Herniation, Stenosis, Spondylolisthesis
Being tested: Exparel, Bupivacaine
Medical subject headings: Low Back Pain, Intervertebral Disc Degeneration, Intervertebral Disc Displacement, Constriction, Pathologic, Spondylolisthesis, Spondylolysis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ExparelDrug
1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL
BupivacaineDrug
30 mL bupivacaine 0.5% w/v solution

Study groups in NCT03514277
Study group	Role	What they receive
Local infiltration of EXPAREL and Bupivacaine	Active comparator	Not described Receives: Drug: Exparel; Drug: Bupivacaine
Local infiltration of Exparel	Active comparator	Not described Receives: Drug: Exparel
Local infiltration of Bupivacaine	Active comparator	Not described Receives: Drug: Bupivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Postoperative Pain Score
Wong-Baker pain faces scale of 0-no pain, to 10-extreme pain
Measured: last day of hospitalization, average of 3 days in hospital

Secondary outcomes (3)

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
Measured: 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
Measured: 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
Measured: last day of hospitalization, average of 3 days in hospital

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 201631 Dec 2019

First posted2 May 2018
Study start1 Dec 2016
Primary completion31 Dec 2019
Study completion31 Dec 2019

Why it stopped: PI decision to close study early

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Low Back PainStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Care provider
Enrolment: 19 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03514277
Sponsor's protocol ID: VirtuaHealthExparel
Status last verified: Dec 2020
First submitted: 15 Mar 2018
Last updated: 6 Jan 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No: Publish research findings in relevant peer-reviewed journal

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT03514277
Acronym / sponsor ID: VirtuaHealthExparel
Conditions: Low Back Pain, Lumbosacral Radiculopathy, Lumbar Disc Degeneration, Lumbar Disc Herniation, Stenosis, Spondylolisthesis
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: PI decision to close study early
Enrolment: 19 participants (actual)
Lead sponsor: Virtua Health, Inc.University, hospital or other
Study start: 1 Dec 2016 (actual)
Primary completion: 31 Dec 2019 (actual)
Study completion: 31 Dec 2019 (actual)
First posted: 2 May 2018 (actual)
Results: Posted 6 Jan 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, care provider)
Number of arms: 3

Arm	Type	Receives
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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (9 listed)

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);

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Exparel1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL	Drug	Local infiltration of EXPAREL and Bupivacaine, Local infiltration of Exparel
Bupivacaine30 mL bupivacaine 0.5% w/v solution	Drug	Local infiltration of Bupivacaine, Local infiltration of EXPAREL and Bupivacaine

Primary outcome

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

3 secondary outcomes

Total Consumption of Opioids During Hospital Stay
Time frame: last day of hospitalization, average of 3 days in hospital
Mean Time to Achieve Physical Therapy Discharge
Time frame: last day of hospitalization, average of 3 days in hospital
Number of Participants With Opioid Related Adverse Events
Time frame: last day of hospitalization, average of 3 days in hospital

Results and safety

Results posted to the registry on 6 Jan 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Local Infiltration of EXPAREL and Bupivacaine	11	11
Local Infiltration of Exparel	4	4
Local Infiltration of Bupivacaine	4	4

Primary outcome: Mean Postoperative Pain Score

Time frame: last day of hospitalization, average of 3 days in hospital. Mean (Full Range). Unit: units on a scale

Measure	Local Infiltration of EXPAREL and Bupivacaine n = 10	Local Infiltration of Exparel n = 4	Local Infiltration of Bupivacaine n = 4
Value	5.2 (3.0 to 7.6)	4.2 (3.1 to 5.6)	5.6 (4.4 to 6.7)

Population analysed: Data is not collected for one patient in the Local infiltration of EXPAREL and Bupivacaine group

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Duration of patient's hospital stay, an average of three days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Local Infiltration of EXPAREL and Bupivacaine	0 of 11 (0%)	1 of 11 (9.1%)	0 of 11
Local Infiltration of Exparel	0 of 4 (0%)	0 of 4 (0%)	0 of 4
Local Infiltration of Bupivacaine	0 of 4 (0%)	1 of 4 (25%)	0 of 4

Limitations and caveats (from the sponsor): Early termination leading to small numbers of subjects analyzed

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Publish research findings in relevant peer-reviewed journal

Related trials for Low Back Pain

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Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Robert Greenleaf, MD principal investigator

Princpal Investigator

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Exparel and Bupivacaine in people with Low Back Pain and Lumbosacral Radiculopathy, run by Virtua Health, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jan 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Postoperative Pain Score (time frame: last day of hospitalization, average of 3 days in hospital). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03514277.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2021.