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

• Status: Terminated
• Trial end date: 2017-07-17
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: St. Joseph's Hospital and Medical Center, Phoenix
• Treatments: Ibuprofen

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