RecruitingPhase 4NCT05746143

The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion

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


Sponsor

University of Southern California

Enrollment

140 participants

Start Date

Feb 1, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is looking at whether a common sleep medication — zolpidem (brand name Ambien) — can improve recovery outcomes for patients undergoing lumbar spine fusion surgery. Back surgery is painful and recovery can be disrupted by poor sleep. Zolpidem helps people fall asleep faster and stay asleep longer, which may help the body heal more effectively. Researchers want to know if giving this medication routinely after surgery leads to better outcomes, fewer complications, or faster recovery compared to patients who do not receive it. To be eligible, you must be between 18 and 75 years old, have a degenerative lumbar spine condition, and be scheduled for an open primary one-to-three level lumbar spinal fusion. People who already take a sleep aid every night, have been diagnosed with insomnia or sleep apnea, have had previous back surgery, or are having minimally invasive or trauma/infection-related surgery are not eligible. This study is important because sleep disruption after surgery is very common and may slow healing, increase pain, and prolong hospital stays. Finding an evidence-based, low-cost intervention to improve sleep — and therefore recovery — after major back surgery could benefit thousands of patients each year.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGZolpidem Tartrate 10 mg

two days preoperatively and five days postoperatively

DRUGPlacebo

two days preoperatively and five days postoperatively


Locations(1)

Keck Medical Center of USC

Los Angeles, California, United States

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NCT05746143


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