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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

Study 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.Check my eligibility

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.See study design

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 weeks3 visits

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

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

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

Primary outcome measures

Overall length of hospital stay from hospital admission to hospital discharge

Secondary outcome measures

30-day narcotic usage

30-day readmission rates

Change in Visual Analog Pain scale scores

+1 more

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,732 Previous Clinical Trials

2,143,448 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

Frequently Asked Questions

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

In what types of medical circumstances is Liposomal Bupivicaine typically employed?

"Administered to treat periphigus, liposomal bupivicaine is also beneficial for acute nonspecific tenosynovitis, general anesthesia, and lupus erythematosus cell."

Answered by AI

What potential risks come with administering Liposomal Bupivicaine to individuals?

"Liposomal Bupivicaine has been deemed to possess a safety rating of 2, as Phase 2 trial data suggests its security but fails to confirm efficacy."

Answered by AI

How many participants are being accepted for this medical experiment?

"Affirmative. According to the information available on clinicaltrials.gov, this medical experiment is still actively looking for participants. The study was initially posted on September 8th 2019 and last modified on February 2nd 2023 in order to recruit 100 patients from a single site."

Answered by AI

Is there a sign-up process currently in place for this research endeavor?

"Per the data available on clinicaltrials.gov, this medical trial is currently enrolling participants - it was initially posted in September 2019 and most recently updated in February 2023."

Answered by AI

Could you elucidate the findings of any investigations conducted surrounding Liposomal Bupivicaine?

"There are currently 100 clinical trials examining the efficacy of Liposomal Bupivicaine, with 15 studies occupying Phase 3. 130 medical sites across the nation have been given permission to run these experiments; some centres in Philadelphia, Pennsylvania are among them."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Outcomes for Lumbar Decompressions With Use of Liposomal Bupivicaine

2019. "Outcomes for Lumbar Decompressions With Use of Liposomal Bupivicaine". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04066296.

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