Liposomal Bupivacaine for Lumbar Spinal Stenosis

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Recruiting

Sponsor: University of Colorado, Denver

No Placebo Group

Prior Safety Data

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

Evaluate the benefit of using liposomal bupivicaine in lumbar laminectomies in terms of length of stay, IV narcotic use, 30-day narcotic use, visual analog score (VAS) and 30-day readmissions

Research Team

Eligibility Criteria

Adults over 18 with lumbar spinal stenosis who haven't had previous surgery at the affected level and don't require a fusion procedure. It's not for those under 18, pregnant or breastfeeding individuals, prisoners, patients with daily high-dose opioid use, or if there are other health issues that make surgery too risky.

Inclusion Criteria

Anyone can participate regardless of gender.

Adult (≥18 yo)

You have a condition called lumbar stenosis.

Exclusion Criteria

≤18 yo

Previous lumbar surgery at indicated level

You are currently pregnant.

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Treatment Details

Interventions

Liposomal Bupivacaine (Local Anesthetic)

Trial OverviewThe trial is testing whether liposomal bupivacaine can improve outcomes after lumbar laminectomy surgeries. It looks at how long patients stay in the hospital, their need for IV and oral narcotics post-surgery, pain levels using VAS scores, and readmission rates within 30 days.

Participant Groups

2Treatment groups

Active Control

Group I: Liposomal BupivicaineActive Control1 Intervention

Treatment with liposomal bupivicaine

Group II: Standard Local AnesthesticActive Control1 Intervention

Treatment with Standard Local Anesthestic

Liposomal Bupivacaine is already approved in United States for the following indications:

🇺🇸 Approved in United States as EXPAREL for: