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Local Anesthetic

Liposomal Bupivacaine for Lumbar Spinal Stenosis

Phase 2
Recruiting
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening, day of procedure, prior to hospital discharge (post-op, up to 2 weeks), up to 30-days post-surgery (follow-up#1) and up to 12-months post-op follow up
Awards & highlights
All Individual Drugs Already Approved
Approved for 10 Other Conditions
No Placebo-Only Group

Summary

This trialfound liposomal bupivicaine reduced length of stay, IV narcotic use, 30-day narcotic use and readmissions, and improved pain scores, in lumbar laminectomies.

Who is the study for?
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.
What is being tested?
The 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.
What are the potential side effects?
Liposomal bupivacaine may cause side effects like nausea, vomiting, constipation due to reduced narcotic use; local reactions such as numbness or tingling; and rare but serious complications like nerve damage.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening, day of procedure, prior to hospital discharge (post-op, up to 2 weeks), up to 30-days post-surgery (follow-up#1) and up to 12-months post-op follow up
This trial's timeline: 3 weeks for screening, Varies for treatment, and screening, day of procedure, prior to hospital discharge (post-op, up to 2 weeks), up to 30-days post-surgery (follow-up#1) and up to 12-months post-op follow up for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall length of hospital stay from hospital admission to hospital discharge
Secondary study objectives
30-day narcotic usage
30-day readmission rates
Change in Visual Analog Pain scale scores
+1 more

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,810 Previous Clinical Trials
2,920,000 Total Patients Enrolled

Media Library

Liposomal Bupivacaine (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT04066296 — Phase 2
Lumbar Spinal Stenosis Research Study Groups: Liposomal Bupivicaine, Standard Local Anesthestic
Lumbar Spinal Stenosis Clinical Trial 2023: Liposomal Bupivacaine Highlights & Side Effects. Trial Name: NCT04066296 — Phase 2
Liposomal Bupivacaine (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04066296 — Phase 2
~0 spots leftby Dec 2024
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