Safety and Efficacy of Pre-incisional Intravenous Ibuprofen to Reduce Postoperative Pain and Opioid Dependence After Posterior Cervical or Lumbar Instrumented Spine Surgery

Study Overview
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Brief Summary
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A prospective, randomized, placebo controlled, double-blinded study at a single institution.

Detailed Description
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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.

Official Title
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Safety and Efficacy of Pre-incisional Intravenous Ibuprofen to Reduce Postoperative Pain and Opioid Dependence After Posterior Cervical or Lumbar Instrumented Spine Surgery

Conditions
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Cervical Spondylosis, Lumbar Spondylosis

Intervention / Treatment
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* Drug: Ibuprofen
* Other: normal saline


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intravenous (IV) ibuprofen<br>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. | Drug: Ibuprofen<br> <br> * Other names: Caldolor;|
| Placebo Comparator: Intravenous (IV) normal saline<br>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. | Other: normal saline<br> <br> * Other names: NS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 |