The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion

Study Overview
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Brief Summary
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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
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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.

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

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

Intervention / Treatment
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* Drug: Zolpidem Tartrate 10 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zolpidem<br> | Drug: Zolpidem Tartrate 10 mg<br>* two days preoperatively and five days postoperatively<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* two days preoperatively and five days postoperatively<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale (VAS) | Visual analog scale (VAS) for back and leg pain; scale range: 0-10, higher scores = increased pain (worse outcome) | Postoperative day five | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Preoperative, Postoperative day three, five, as well as two weeks and six weeks | 
| Morphine Equivalents | values that represent the potency of an opioid dose relative to morphine | Postoperative day one, two, three, four, five, and two weeks | 
| Quality of Recovery - 40 (QoR-40) questionnaire | Patient Reported Outcome; score range: 40-200, higher score = greater recovery (better outcome) | Preoperative, Postoperative day three, five, as well as two weeks and six weeks | 
| Epworth Sleepiness Score (ESS) | Patient Reported Outcome; score range: 0-24; higher score = greater daytime sleepiness (worse outcome) | Preoperative, Postoperative day three, five, as well as two weeks and six weeks | 
| Pain Catastrophizing Scale (PCS) | Patient Reported Outcome; scale range: 0-24, higher score = higher pain catastrophizing (worse outcome) | Preoperative, Postoperative day three, five, as well as two weeks and six weeks | 
| Hospital Length of Stay |  | Postoperative two-weeks | 
| Postoperative complications |  | Postoperative two-years | 
| Visual analog scale (VAS) | Visual analog scale (VAS) for back and leg pain; scale range: 0-10, higher scores = increased pain (worse outcome) | preoperative, postoperative day one, three, as well as two weeks and six weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lumbar Spine Fusion, Zolpidem, Postoperative Outcomes