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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
Select...
I am having or have had a one-level spinal fusion surgery from the back.
Select...
I have been diagnosed with a spinal condition but not degenerative disc disease.

Timeline

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

Find a Location

Who is running the clinical trial?

Allina Health SystemLead Sponsor
57 Previous Clinical Trials
1,177,154 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
~9 spots leftby Jun 2025
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