NCT05746143PHASE4Recruiting
The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion
University of Southern California
Start Date
2/1/2022
Completion Date
12/31/2030
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.
Eligibility Criteria
Age Range: 18 years to 75 years
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
Interventions
DRUG
Zolpidem Tartrate 10 mg
DRUG
Placebo
Conditions
Spine FusionLumbar Spine DegenerationPain, PostoperativeLumbar Spine Spondylosis
Locations
Keck Medical Center of USC
Los Angeles, California 90033
United States