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Recruiting NCT05746143

The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion

Phase IV Interventional Spine Fusion Lumbar Spine Degeneration Pain, Postoperative Lumbar Spine Spondylosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Zolpidem Tartrate 10 mg, Placebo.
Who it may be relevant to
Registry conditions: Spine Fusion, Lumbar Spine Degeneration, Pain, Postoperative, Lumbar Spine Spondylosis. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Zolpidem Tartrate 10 mg
    two days preoperatively and five days postoperatively
  • Drug Placebo
    two days preoperatively and five days postoperatively

Primary outcome measures

  • Visual analog scale (VAS) [Time frame: Postoperative day five]
Secondary outcome measures (8)
  • Oswestry Disability Index (ODI) [Time frame: Preoperative, Postoperative day three, five, as well as two weeks and six weeks]
  • Morphine Equivalents [Time frame: Postoperative day one, two, three, four, five, and two weeks]
  • Quality of Recovery - 40 (QoR-40) questionnaire [Time frame: Preoperative, Postoperative day three, five, as well as two weeks and six weeks]
  • Epworth Sleepiness Score (ESS) [Time frame: Preoperative, Postoperative day three, five, as well as two weeks and six weeks]
  • Pain Catastrophizing Scale (PCS) [Time frame: Preoperative, Postoperative day three, five, as well as two weeks and six weeks]
  • Hospital Length of Stay [Time frame: Postoperative two-weeks]
  • Postoperative complications [Time frame: Postoperative two-years]
  • Visual analog scale (VAS) [Time frame: preoperative, postoperative day one, three, as well as two weeks and six weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Triple blind
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Keck Medical Center of USC — Los Angeles

Identifiers

NCT: NCT05746143 · HS-22-00529

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗