Lumbar Spine Degeneration, Lumbar Spine Spondylosis, Pain, Postoperative, Spine Fusion
Conditions
Keywords
Lumbar Spine Fusion, Zolpidem, Postoperative Outcomes
Brief summary
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
two days preoperatively and five days postoperatively
DRUGPlacebo
two days preoperatively and five days postoperatively
Sponsors
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual analog scale (VAS) | Postoperative day five | Visual analog scale (VAS) for back and leg pain; scale range: 0-10, higher scores = increased pain (worse outcome) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Oswestry Disability Index (ODI) | 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) |
| Morphine Equivalents | Postoperative day one, two, three, four, five, and two weeks | values that represent the potency of an opioid dose relative to morphine |
| Quality of Recovery - 40 (QoR-40) questionnaire | 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) |
| Epworth Sleepiness Score (ESS) | 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) |
| Pain Catastrophizing Scale (PCS) | 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) |
| Hospital Length of Stay | Postoperative two-weeks | — |
| Postoperative complications | Postoperative two-years | — |
| Visual analog scale (VAS) | 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) |
Countries
United States
Contacts
CONTACTPui Yan, MS
Outcome results
None listed