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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

Must not have

Is opioid-tolerant. Opioid tolerant patients are receiving, for one week or longer, at least 60 mg oral morphine/day, 25 mcg transdermal fentanyl/hour, 30 mg oral oxycodone/day, 8 mg oral hydromorphone/day, 25 mg oral oxymorphone/day, or an equianalgesic dose of another opioid.

Is less than 18 years old.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion, an average of 2.5 days

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have been taking a strong painkiller regularly for more than a week.

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I am under 18 years old.

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I have severe kidney disease.

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I had complications during surgery, such as a tear in the dura.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Visual Analog Pain Scores

Secondary study objectives

Discomfort

Length of Stay

Number of Opioid-related Adverse Events

+3 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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 / 6Eligibility criteria met