Health TrialsbyHealthPanel

The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion

ConditionsSpine FusionLumbar Spine DegenerationPain, PostoperativeLumbar Spine Spondylosis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversity of Southern California

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

degenerative lumbar disease

age of 18-75

undergoing open primary one- to three-level lumbar fusion

Disqualifiers

currently use a sleep aid nightly

diagnosed with insomnia or sleep apnea

history of delirium with opiates or zolpidem

allergic to opiates or zolpidem

Trial design

Design model

Parallel

Treatments tested in this trial

  • Zolpidem Tartrate 10 mg

    Drug

    two days preoperatively and five days postoperatively

  • Placebo

    Drug

    two days preoperatively and five days postoperatively

Treatment groups

140 Participants
are divided into 2 treatment groups
Group A: ZolpidemExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Visual analog scale (VAS)

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

Time frame
Postoperative day five

Secondary outcomes

1

Oswestry Disability Index (ODI)

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)

Time frame
Preoperative, Postoperative day three, five, as well as two weeks and six weeks
2

Morphine Equivalents

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

Time frame
Postoperative day one, two, three, four, five, and two weeks
3

Quality of Recovery - 40 (QoR-40) questionnaire

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

Time frame
Preoperative, Postoperative day three, five, as well as two weeks and six weeks
4

Epworth Sleepiness Score (ESS)

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Southern California

Lead sponsor

Source ClinicalTrials.gov
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