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NCT Number: NCT05746143

The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion

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

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Key information

Conditions

Spine Fusion Lumbar Spine Degeneration Lumbar Spine Spondylosis Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Keck Medical Center of USC

Los Angeles, California, 90033, United States

Location status: Recruiting

Location contact

Pui Yan, MS

CONTACT

[email protected]

323-442-6984

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Zolpidem Tartrate 10 mg

Drug

two days preoperatively and five days postoperatively

Placebo

Drug

two days preoperatively and five days postoperatively

Primary outcomes

  1. Visual analog scale (VAS)

    Time frame: Postoperative day five

    Visual analog scale (VAS) for back and leg pain; scale range: 0-10, higher scores = increased pain (worse outcome)

Secondary outcomes

  1. Oswestry Disability Index (ODI)

    Time frame: Preoperative, Postoperative day three, five, as well as two weeks and six weeks

    Patient reported outcome with regard to low back pain and function; score range: 0-100%, higher scores = higher disability from low back pain (worse outcome)

  2. Morphine Equivalents

    Time frame: Postoperative day one, two, three, four, five, and two weeks

    values that represent the potency of an opioid dose relative to morphine

  3. Quality of Recovery - 40 (QoR-40) questionnaire

    Time frame: Preoperative, Postoperative day three, five, as well as two weeks and six weeks

    Patient Reported Outcome; score range: 40-200, higher score = greater recovery (better outcome)

  4. Epworth Sleepiness Score (ESS)

    Time frame: Preoperative, Postoperative day three, five, as well as two weeks and six weeks

    Patient Reported Outcome; score range: 0-24; higher score = greater daytime sleepiness (worse outcome)

  5. Pain Catastrophizing Scale (PCS)

    Time frame: Preoperative, Postoperative day three, five, as well as two weeks and six weeks

    Patient Reported Outcome; scale range: 0-24, higher score = higher pain catastrophizing (worse outcome)

  6. Hospital Length of Stay

    Time frame: Postoperative two-weeks

  7. Postoperative complications

    Time frame: Postoperative two-years

  8. Visual analog scale (VAS)

    Time frame: preoperative, postoperative day one, three, as well as two weeks and six weeks

    Visual analog scale (VAS) for back and leg pain; scale range: 0-10, higher scores = increased pain (worse outcome)

Study contacts

Contact information is provided by the study sponsor or research team.

Pui Yan, MS

CONTACT

[email protected]

323-442-6984

Sponsors and collaborators

Lead sponsor

University of Southern California

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2029
Study completion
2030
First posted
Feb 27, 2023
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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