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Liposomal Bupivacaine for Spine Surgery Pain

Phase 4

Recruiting

Led By Christopher Alcala-Marquez, MD

Research Sponsored by Allina Health System

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Receives open, one-level posterior spinal fusion

Has a primary diagnosis of single-level lumbar stenosis, disc herniation, and/or spondylolisthesis excluding degenerative disc disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 2.5 days

Awards & highlights

Study Summary

This trial will compare post-operative pain management for spine surgery patients receiving liposomal bupivacaine to those who do not receive the drug.

Who is the study for?

This trial is for adults with a single-level lumbar condition like spinal stenosis, disc herniation, or spondylolisthesis who are undergoing one-level posterior spinal fusion. It's not for those under 18, pregnant women, non-English speakers, patients with severe liver or kidney disease, opioid-tolerant individuals, or anyone who had complications during surgery.Check my eligibility

What is being tested?

The study is testing the effectiveness of liposomal bupivacaine (Exparel®) in managing postoperative pain compared to standard care without this drug in spine surgery patients.See study design

What are the potential side effects?

Liposomal bupivacaine may cause side effects such as nausea, vomiting, constipation and might lead to nerve damage if injected improperly. There could also be reactions at the injection site like swelling or pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am having or have had a one-level spinal fusion surgery from the back.

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I have been diagnosed with a spinal condition but not degenerative disc disease.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion, an average of 2.5 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion, an average of 2.5 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion, an average of 2.5 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Visual Analog Pain Scores

Secondary outcome measures

Discomfort

Length of Stay

Number of Opioid-related Adverse Events

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Group A: ExparelExperimental Treatment1 Intervention

Standard of Care plus Liposomal bupivacaine (Exparel®). Dosage: Exparel® 20 mL single use vial, 1.3% (13.3 mg/mL), Maximum dose of 266 mg (20 mL). Frequency: Single intraoperative administration

Group II: Group B: No ExparelActive Control1 Intervention

Standard of Care

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Liposomal bupivacaine

2016

Completed Phase 4

~1970

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Allina Health SystemLead Sponsor

56 Previous Clinical Trials

1,175,154 Total Patients Enrolled

Twin Cities Spine CenterOTHER

2 Previous Clinical Trials

226 Total Patients Enrolled

Christopher Alcala-Marquez, MDPrincipal InvestigatorAllina Health System

Media Library

Liposomal bupivacaine Clinical Trial Eligibility Overview. Trial Name: NCT03745040 — Phase 4

Lumbar Spinal Stenosis Research Study Groups: Group A: Exparel, Group B: No Exparel

Lumbar Spinal Stenosis Clinical Trial 2023: Liposomal bupivacaine Highlights & Side Effects. Trial Name: NCT03745040 — Phase 4

Liposomal bupivacaine 2023 Treatment Timeline for Medical Study. Trial Name: NCT03745040 — Phase 4

Lumbar Spinal Stenosis Patient Testimony for trial: Trial Name: NCT03745040 — Phase 4

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

In what clinical situations is Liposomal bupivacaine commonly employed?

"Liposomal bupivacaine has been proven to be an effective medical intervention for permphigus, acute nonspecific tenosynovitis, and general anesthesia."

Answered by AI

What sort of risks do patients face when using Liposomal bupivacaine?

"Liposomal bupivacaine has safety ratings of 3 since this Phase 4 trial confirms its approval."

Answered by AI

Are participants being accepted at this time for the experiment?

"Affirmative. On clinicaltrials.gov, the details of this trial suggest that it remains open for recruitment as of 2/22/2021. Initially posted on 1/26/2019, the study seeks to admit 60 participants from two different sites."

Answered by AI

What evidence has been gathered regarding Liposomal bupivacaine?

"Currently, there are 18 studies in Phase 3 and 109 live trials involving Liposomal bupivacaine. Most of these clinical trials have sites located in Philadelphia, Pennsylvania but other cities across the country also offer this research study to patients."

Answered by AI

How many persons are actively participating in this clinical experiment?

"Affirmative. Clinicaltrials.gov confirms that this research is actively seeking participants, which began on the 26th of January 2019 and was last updated on 22nd February 2022. 60 patients need to be enrolled from two different sites for the trial to proceed."

Answered by AI