TerminatedPhase 2

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

Stopped: No enrollment

United States6 participantsStarted 2015-03-01

Plain-language summary

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

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in pain level

Timeframe: pre-operative, 1-3 weeks post-operative, 6 months post-operative

Change in overall health/function

Timeframe: pre-operative, 1-3 weeks post-operative, 6 months post-operative

Fusion rates

Timeframe: 6 month post-operative

Trial details

NCT IDNCT02276911

SponsorSt. Joseph's Hospital and Medical Center, Phoenix

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-06-01

View on ClinicalTrials.gov More Cervical Spondylosis trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.