Using liposomal bupivacaine in lumbar decompression surgeries
A Double Blinded Randomized Control Trial in Outcomes for Lumbar Decompressions With Use of Liposomal Bupivicaine
This study is testing if using liposomal bupivacaine during back surgery can help people stay in the hospital for a shorter time and use less pain medication afterward.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Colorado, Denver Academic / other |
| Locations | 1 site (Aurora, Colorado) |
| Trial ID | NCT04066296 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of liposomal bupivacaine in lumbar laminectomies, focusing on its impact on hospital stay duration, intravenous narcotic use, post-operative narcotic consumption, visual analog scores for pain, and readmission rates within 30 days. The hypothesis is that liposomal bupivacaine will lead to shorter hospital stays and reduced narcotic usage compared to traditional methods. The study involves adult patients diagnosed with lumbar spinal stenosis who meet specific inclusion criteria.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with lumbar spinal stenosis who do not have contraindications for surgery.
Not a fit: Patients with significant co-morbidities, those requiring instrumented fusion, or those with a history of previous lumbar surgery at the indicated level may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce recovery time and narcotic dependency for patients undergoing lumbar decompression surgeries.
How similar studies have performed: Previous studies have shown positive outcomes with liposomal bupivacaine in other lumbar spine surgeries, suggesting potential for success in this application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or Female 2. Adult (≥18 yo) 3. Lumbar stenosis Exclusion Criteria: 1. Co-morbidities precluding surgery 2. ≤18 yo 3. Pregnant 4. Breastfeeding 5. Need for instrumented fusion 6. Prisoners 7. Intra-operative CSF leak (identified by gush of CSF) 8. Daily pre-operative opioid use of \> 25 morphine Eq/day 9. Previous lumbar surgery at indicated level
Where this trial is running
Aurora, Colorado
- University of Colorado Anschutz Medical Campus — Aurora, Colorado, United States (Recruiting)
Study contacts
- Study coordinator: Jens-Peter Witt, MD, PhD
- Email: peter.witt@cuanschutz.edu
- Phone: 303-724-2306
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.