Comparing local and MAC anesthesia for lumbar decompression surgery
Randomized Study Comparing Local/ MAC Anesthesia to General for 1-3 Level Lumbar Decompressions
This study tests whether using local anesthesia with monitored care is as safe and effective as general anesthesia for patients having lumbar decompression surgery for spinal stenosis.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 40 Years to 95 Years |
| Sex | All |
| Sponsor | Stanford University Academic / other |
| Locations | 2 sites (Redwood City, California and 1 other locations) |
| Trial ID | NCT04992572 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness and safety of using local anesthesia combined with monitored anesthesia care (MAC) compared to general anesthesia for patients undergoing lumbar decompression surgery due to spinal stenosis. A total of 100 patients aged 40 to 95 will be randomly assigned to receive either general anesthesia or local anesthesia with MAC during their procedure. The study aims to analyze patient outcomes, complications, and overall experiences associated with each anesthetic approach.
Who should consider this trial
Good fit: Ideal candidates are patients aged 40-95 with lumbar stenosis who are appropriate for general anesthesia.
Not a fit: Patients with significant nerve root retraction planned, previous fusion operations, or known hypersensitivity to the anesthetics used may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more comfortable anesthesia option for patients undergoing lumbar decompression surgery.
How similar studies have performed: Other studies have shown promising results with local anesthesia and MAC in similar surgical settings, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patients with lumbar stenosis to be decompressed over 1-3 segments * Ages 40-95 * Appropriate for general anesthesia Exclusion Criteria: * Planned significant nerve root retraction * Previous fusion operation * Unable to comply with follow up * Patients with daily morphine equivalents or more 100mg * Patients with a known hypersensitivity to propofol or any of DIPRIVAN Injectable Emulsion components. * Patients with allergies to eggs, egg products, soybeans or soy products.
Where this trial is running
Redwood City, California and 1 other locations
- Outpatient Surgery Center/Stanford Spine Clinic — Redwood City, California, United States (Recruiting)
- Stanford Outpatient surgery center — Redwood City, California, United States (Recruiting)
Study contacts
- Principal investigator: Todd Alamin, MD — Stanford University
- Study coordinator: Sarah Miller, MAS
- Email: sarahmi@stanford.edu
- Phone: 650-725-7984
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.