Pain, Postoperative Clinical Trial
Official title:
The Effect of Zolpidem on Outcomes Following Lumbar Spine Fusion: A Randomized Control Trial
The purpose of this study is to evaluate if peri-operative zolpidem for posterior lumbar spinal fusion improves patient reported outcomes following surgery.
Status | Recruiting |
Enrollment | 140 |
Est. completion date | December 31, 2025 |
Est. primary completion date | December 31, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Keck Medical Center of USC | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
University of Southern California |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | Morphine Equivalents | values that represent the potency of an opioid dose relative to morphine | Postoperative day one, two, three, four, five, and two weeks | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | Hospital Length of Stay | Postoperative two-weeks | ||
Secondary | Postoperative complications | Postoperative two-years | ||
Secondary | 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 |
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