The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion

University of Southern California

Status and phase: Enrolling; Phase 4

Conditions: Lumbar Spine Degeneration; Spine Fusion; Lumbar Spine Spondylosis; Pain, Postoperative

Treatments: Drug: Zolpidem Tartrate 10 mg; Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05746143

HS-22-00529

Details and patient eligibility

About

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

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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140 participants in 2 patient groups, including a placebo group

Zolpidem

Experimental group

Treatment:

Drug: Zolpidem Tartrate 10 mg

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo