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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zolpidem | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zolpidem Tartrate 10 mg | Drug | two days preoperatively and five days postoperatively |
| |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Pui Yan, MS | Contact | 323-442-6984 | puiyan@med.usc.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Keck Medical Center of USC | Recruiting | Los Angeles | California | 90033 | United States |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D000077334 | Zolpidem |
| ID | Term |
|---|---|
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo |
| Drug |
two days preoperatively and five days postoperatively |
|
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 |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |