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 |
|---|---|
| Conditions: | Post-Surgical Pain, Orthopedic, Women's Studies |
| Therapuetic Areas: | Musculoskeletal, Orthopedics / Podiatry, Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 8/25/2018 |
| Start Date: | March 1, 2015 |
| End Date: | July 17, 2017 |
A prospective, randomized, placebo controlled, double-blinded study at a single institution.
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.
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.
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
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