Liposomal Bupivacaine for Lumbar Spinal Stenosis

Overseen By Akal Sethi, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Colorado, Denver

Must not be taking: Opioids

Disqualifiers: Pregnant, Breastfeeding, Prisoners, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Up to 2 weeks

100 Participants Needed

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

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo lumbar laminectomies with either liposomal bupivicaine or standard local anesthetic

Up to 2 weeks

Inpatient stay

Follow-up

Participants are monitored for narcotic usage, pain levels, and readmission rates

30 days

1 visit (in-person), additional assessments via electronic medical records

Long-term follow-up

Participants' pain levels are assessed up to 12 months post-operation

12 months

Treatment Details

Interventions

• Liposomal Bupivacaine

Trial Overview 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.

Participant Groups

Group I: Liposomal Bupivicaine Active Control 1 Intervention

Treatment with liposomal bupivicaine

Group II: Standard Local Anesthestic Active Control 1 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:

• Postsurgical local analgesia via infiltration in adults
• Regional analgesia via interscalene brachial plexus nerve block in adults

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+