The Effect of IV NSAID's and Corticosteroids on Dysphasia and Dysphonia Following ASDF

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Intravenous Non-steroidal Anti-inflammatory Drugs and Intravenous Corticosteroids on the Likelihood of Dysphagia and Dysphonia Following Anterior Cervical Discectomy and Fusion

Conditions
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Dysphonia, Dysphagia

Intervention / Treatment
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* Drug: Intravenous Ketorolac
* Drug: Intravenous Dexamethasone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 25 patients into 3 separate arms.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br>no steroid or non steroidal anti-inflammatory | Drug: Placebo<br>* Control<br>|
| Active Comparator: Ketorolac<br>one time dose of 30mg of IV Ketorolac at time of closure | Drug: Intravenous Ketorolac<br>* To assess the efficacy of the meds for dysphagia and dysphonia following ACDF<br>|
| Active Comparator: dexamethasone<br>one time dose of 10mg of IV dexamethasone at the time of closure | Drug: Intravenous Dexamethasone<br>* To assess the efficacy of the meds for dysphagia and dysphonia following ACDF<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with Moderate/Severe Bazaz Classification | The Bazaz grading system (0-none; 1-Mild; 2-Moderate; 3-Severe) is used for dysphagia evaluation | one year | 
| Percentage of patients with severe dysphagia based on the Eating Assessment Tool (EAT-10) | Scores on the EAT-10 greater than 15 are indicative of severe dysphonia | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with clinically significant Voice Handicap Index-10 (VHI-10). | Scores on the VHI-10 greater than 11 are indicative of clinically significant dysphonia. Scores on the VHI-10 greater than 11 are indicative of clinically significant dysphonia. Scores on the VHI-10 greater than 11 are indicative of clinically significant dysphonia. Scores on the VHI-10 greater than 11 are indicative of clinically significant dysphonia. Scores on the VHI-10 greater than 11 are indicative of clinically significant dysphonia. Scores on the VHI-10 greater than 11 are indicative of clinically significant dysphonia. Scores on the VHI-10 greater than 11 are indicative of clinically significant dysphonia. Scores on the VHI-10 greater than 11 are indicative of clinically significant dysphonia | one year | 
| Mean Neck Disability Index (NDI) | The Neck Disability Index (NDI) is a 10 item pain intensity and daily activity questionnaire that measures daily limitations after cervical spine injury. The Neck Disability Index (NDI) is a 10 item pain intensity and daily activity questionnaire that measures daily limitations after cervical spine injury. The Neck Disability Index (NDI) is a 10 item pain intensity and daily activity questionnaire that measures daily limitations after cervical spine injury. The Neck Disability Index (NDI) is a 10 item pain intensity and daily activity questionnaire that measure daily limitations after cervical spine injury | one year |