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

13BN033

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

2015-03-01

2017-06-01

2017-07-17

Terminated

Early phase I

6

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 6, 'type': 'ACTUAL'}}

2024-04-19