Evaluating the impact of zolpidem on recovery after lumbar spine fusion surgery
The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion: A Randomized Control Trial
This study is testing if giving a sleep aid called zolpidem to patients having spine surgery can help them recover better and feel less pain.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 140 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Southern California Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT05746143 on ClinicalTrials.gov |
What this trial studies
This study aims to assess whether administering zolpidem, a sleep aid, around the time of lumbar spine fusion surgery can enhance patient-reported outcomes. Patients aged 18 to 75 with degenerative lumbar disease will be randomly assigned to receive either zolpidem or a placebo starting two days before surgery and continuing for five days post-surgery. The focus is on one- to three-level spinal fusion procedures, and the outcomes will be measured based on patient feedback regarding their recovery and pain levels.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with degenerative lumbar disease who are scheduled for open primary one- to three-level lumbar fusion.
Not a fit: Patients who regularly use sleep aids, have insomnia or sleep apnea, or have a history of complications with zolpidem or opiates may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved recovery experiences and outcomes for patients undergoing lumbar spine fusion.
How similar studies have performed: While the use of zolpidem in this context is relatively novel, similar studies exploring the impact of sleep aids on postoperative outcomes have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * degenerative lumbar disease * age of 18-75 * undergoing open primary one- to three-level lumbar fusion Exclusion Criteria: * currently use a sleep aid nightly * diagnosed with insomnia or sleep apnea * history of delirium with opiates or zolpidem * allergic to opiates or zolpidem * had previous lumbar spine surgery * undergoing minimally invasive lumbar fusion, * undergoing lumbar fusion for fracture, infection, tumor, or an inflammatory spondyloarthropathy
Where this trial is running
Los Angeles, California
- Keck Medical Center of USC — Los Angeles, California, United States (Recruiting)
Study contacts
- Study coordinator: Pui Yan, MS
- Email: puiyan@med.usc.edu
- Phone: 323-442-6984
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.