Status:
TERMINATED
Safety and Efficacy of Pre-incisional Intravenous Ibuprofen to Reduce Postoperative Pain and Opioid Dependence After Posterior Cervical or Lumbar Instrumented Spine Surgery
Lead Sponsor:
St. Joseph's Hospital and Medical Center, Phoenix
Conditions:
Cervical Spondylosis
Lumbar Spondylosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 reduce...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 17 2017
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT02276911
Start Date
March 1 2015
End Date
July 17 2017
Last Update
April 19 2024
Active Locations (1)
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1
SJHMC/Barrow Neurosurgical Associates
Phoenix, Arizona, United States, 85013