Phoenix, Arizona 85013


Purpose:

A prospective, randomized, placebo controlled, double-blinded study at a single institution.


Study summary:

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.


Criteria:

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


NCT ID:

NCT02276911


Primary Contact:

Principal Investigator
Nicholas Theodore, MD
St. Joseph Hospital and Medical Center

Jill Danielson, RN
Phone: 602-406-6335
Email: jill.danielson@dignityhealth.org


Backup Contact:

Email: james.kalyvas@bnaneuro.net
James Kalyvas, MD
Phone: 602-406-3181


Location Contact:

Phoenix, Arizona 85013
United States

Jill Danielson, RN, MSN
Phone: 602-406-6335
Email: jill.danielson@dignityhealth.org

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 19, 2017

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