Overview
This study is to assess the efficacy of intraoperative intravenous nonsteroidal anti-inflammatory drug (ketorolac) versus intravenous (dexamethosone) administration on dysphagia and dysphonia after ACDF.
Description
The purpose of this study is to assess the efficacy of two intraoperative, intravenous medications on dysphagia and dysophonia following anterior cervical discectomy and fusion(ACDF). The medications include Ketorolac, an anti-inflammatory versus dexamethasone, a corticosteroid. Eligibility criteria includes adults aged 19 years of age or older who are scheduled to undergo a ACDF for radiculopathy or myelopathy by Drs. Cornett and Vincent at Nebraska Medicine. Subjects will be recruited for a prospective, randomzed, single-blinded clinical drug study and randomized into three cohorts: (1) control (no steroid or non-steroidal anti-inflammatory (NSAID), (2) IV NSAID(1-time dose of 30mg of IV Ketorolac at time of closure), and (3) IV steroid (1-time dose of 10mg of IV dexamethasone at the time of closure. The primary outcome measures are patient questionnaires which include the EAT-10 and Bazaz classification for dysphagia and VHI-10 for dysphonia. In addition, the Neck Disability Index (NDI) and Visual Analogue Pain Scale (VAS) will also be collected. Research follow-up will be subject completed questionnaires to be collected pre-operatively and then post operation at day 1, 3 weeks, 6 weeks, 3 months, 6 months, and 1 year. Post operative questionnaires may be collected at time of patient follow-up in clinic, by phone or mail.
Eligibility
Inclusion Criteria:
- 19 years of age and older
- Undergoing ACDF for radiculopathy or myelopathy
- No known allergies or sensitivities to steroid or non-steroidal medications
Exclusion Criteria:
- Procedure is being done for revision, trauma, infection or tumor
- Patients with known diagnosed metabolic diseases (diabetes, pancreatitis, gout, electrolyte imbalances, hypertension, hematological abnormalities including gastrointestional bleeding...)
- Patients with known kidney disease or a creatinine level above the upper limit of normal >1.27