Actively Recruiting
The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion: A Randomized Control Trial
Led by University of Southern California · Updated on 2026-05-01
140
Participants Needed
1
Research Sites
99 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying patients with degenerative lumbar disease who are undergoing one- to three-level spinal fusion surgery to see if taking zolpidem around the time of surgery improves patient-reported outcomes. This randomized controlled trial compares zolpidem to a placebo to evaluate its effects following lumbar spine fusion. Participants will be randomly assigned to receive either zolpidem or a placebo starting two days before surgery and continuing for five days after surgery. The study uses a triple-blind design to monitor outcomes under controlled conditions. During the study, patients will complete various assessments including the Visual Analog Scale for pain, Oswestry Disability Index, Quality of Recovery questionnaire, Epworth Sleepiness Score, and Pain Catastrophizing Scale at multiple time points before and after surgery. Researchers will also track morphine use, hospital stay length, and any postoperative complications up to two years following surgery.
CONDITIONS
Brief Title
The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with degenerative lumbar disease
- Age between 18 and 75 years
- Scheduled for open primary one- to three-level lumbar fusion surgery
You will not qualify if you...
- Currently use a sleep aid every night
- Diagnosed with insomnia or sleep apnea
- History of delirium with opiates or zolpidem
- Allergic to opiates or zolpidem
- Previous lumbar spine surgery
- Undergoing minimally invasive lumbar fusion
- Undergoing lumbar fusion for fracture, infection, tumor, or inflammatory spondyloarthropathy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 7 days total
Participants receive zolpidem or placebo starting two days before surgery and continuing for five days after surgery.
1 preoperative visit and daily visits during the postoperative period up to Day 5
Duration - Up to 2 years
Participants are monitored for recovery and outcomes including pain, disability, quality of recovery, sleepiness, and complications.
Multiple visits including postoperative days 1, 3, 5, 14, 42 and long-term assessments up to 2 years
Trial Site Locations
Total: 1 location
1
Keck Medical Center of USC
Los Angeles, California, United States, 90033
Actively Recruiting
Research Team
P
Pui Yan, MS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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