Cervical Spondylosis, Lumbar Spondylosis
Conditions
Brief summary
A prospective, randomized, placebo controlled, double-blinded study at a single institution.
Detailed description
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.
Interventions
DRUGIbuprofen
OTHERnormal saline
Sponsors
St. Joseph's Hospital and Medical Center, Phoenix
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients older than 18 years of age * Able to give consent * Diagnosed with spondylosis, stenosis, and/or instability of the cervical spine * Diagnosed with spondylosis, stenosis, and/or instability of the lumbar spine * Require a posterior decompression with internal fixation * Likely to complete the trial
Exclusion criteria
* Patients with previous surgery at the treated spine segment * Women who are pregnant or plan to become pregnant during the study period Renal/liver disease * Anemia; coagulopathy * Thrombocytopenia (\<30,000) * Coronary artery disease * Previous coronary artery bypass graft (CABG) * Patients taking Coumadin, Plavix, Lithium, or ACE-inhibitors plus Lasix; non-steroidal anti-inflammatory drug (NSAID) hypersensitivity * Gastric ulcers * Recent stroke * Traumatic brain injury, or intracranial surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain level | pre-operative, 1-3 weeks post-operative, 6 months post-operative | Visual Analog Scale (VAS) scores at rest and with movement, Macqill Pain Questionnaire scores, and total morphine and morphine equivalents used during hospital admission. |
| Change in overall health/function | pre-operative, 1-3 weeks post-operative, 6 months post-operative | SF-36 scores, total length of hospital stay, time to ambulation, and time to return to work. |
| Fusion rates | 6 month post-operative | Assessed by plain x-rays or CT scans. |
Countries
United States
Outcome results
None listed