Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Dysphagia
  • Dysphonia
Type
Interventional
Phase
Phase 3
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: 25 patients into 3 separate arms.Masking: Single (Participant)Masking Description: Only patients will be masked from which cohort they were randomized into.Primary Purpose: Treatment

Participation Requirements

Age
Between 19 years and 125 years
Gender
Both males and females

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...

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.

Tracking Information

NCT #
NCT04650893
Collaborators
Not Provided
Investigators
Study Chair: Kevin Garvin, M.D. UNMC