NCT05746143

The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion

The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion: A Randomized Control Trial

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate if peri-operative zolpidem for posterior lumbar spinal fusion improves patient reported outcomes following surgery.

Detailed description

Patients who are undergoing one- to three-level spinal fusion for degenerative lumbar disease will be recruited. They will be randomized to either receive zolpidem or placebo two days preoperatively and five days postoperatively.

Conditions

• Spine Fusion
• Lumbar Spine Degeneration
• Pain, Postoperative
• Lumbar Spine Spondylosis

Interventions

Type	Name	Description
DRUG	Zolpidem Tartrate 10 mg	two days preoperatively and five days postoperatively
DRUG	Placebo	two days preoperatively and five days postoperatively

Timeline

• Start date: 2022-02-01
• Primary completion: 2026-01-31
• Completion: 2027-12-31
• First posted: 2023-02-27
• Last updated: 2024-06-25

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study