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No enrollment
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A prospective, randomized, placebo controlled, double-blinded study at a single institution.
Pain medicine literature and the principal investigator's anecdotal experience in posterior cervical and lumbar instrumented spine surgery suggest that pre-incisional IV ibuprofen significantly reduces postoperative pain without increasing surgical complications or fusion rate, which leads to earlier ambulation, less dependence on narcotic medications, shorter hospital stays, and earlier return to work. The purpose of this study is to assess if these anecdotal findings hold true in a randomized clinical trial of patients with cervical or lumbar spondylosis, who are undergoing decompression and instrumented fusion of the spine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous (IV) ibuprofen | Active Comparator | 800mg IV ibuprofen before incision, followed by four total scheduled doses of IV ibuprofen every six hours for 24 hours, in addition to whatever narcotic or other pain control regimens prescribed by the treating physician to control postoperative pain. |
|
| Intravenous (IV) normal saline | Placebo Comparator | 800mg normal saline before incision, followed by four total scheduled doses of IV ibuprofen every six hours for 24 hours, in addition to whatever narcotic or other pain control regimens prescribed by the treating physician to control postoperative pain. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen | Drug |
|
| |
| normal saline |
| Measure | Description | Time Frame |
|---|---|---|
| Change in pain level | Visual Analog Scale (VAS) scores at rest and with movement, Macqill Pain Questionnaire scores, and total morphine and morphine equivalents used during hospital admission. | pre-operative, 1-3 weeks post-operative, 6 months post-operative |
| Change in overall health/function | SF-36 scores, total length of hospital stay, time to ambulation, and time to return to work. | pre-operative, 1-3 weeks post-operative, 6 months post-operative |
| Fusion rates | Assessed by plain x-rays or CT scans. | 6 month post-operative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicholas Theodore, MD | St. Joseph Hospital and Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SJHMC/Barrow Neurosurgical Associates | Phoenix | Arizona | 85013 | United States |
The study was closed due to low enrollment. There was no data analysis done so there will be no information to share.
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| Other |
|
|
| ID | Term |
|---|---|
| D055009 | Spondylosis |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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