Clinical trial NCT04650893: The Effect of IV NSAID's and Corticosteroids on Dysphasia and Dysphonia Following ASDF
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Dysphagia
Dysphonia
Lead sponsor: University of Nebraska
Sponsor class: OTHER
First posted: 2020-12-03
Enrollment: 33
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 25 patients into 3 separate arms.
Primary purpose: TREATMENT

Brief summary: This study is to assess the efficacy of intra-operative intravenous non-steroidal anti-inflammatory drug (Ketorolac) versus intravenous (dexamethasone) administration on dysphagia and dysphonia after anterior cervical discectomy and fusion (ACDF).

Detailed description: The purpose of this study is to assess the efficacy of two intra-operative, intravenous medications on dysphagia and dysphonia 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. Participants will be recruited for a prospective, randomized, 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 criteria: Inclusion Criteria:

* 19 years of age and older
* Undergoing anterior cervical discectomy and fusion (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 gastrointestinal bleeding...)
* Patients with known kidney disease or a creatinine level above the upper limit of normal \>1.27

Primary outcomes:
measure: Percentage of Patients With Moderate/Severe Bazaz Classification
timeFrame: one year
measure: Percentage of Patients With Severe Dysphagia Based on the Eating Assessment Tool (EAT-10)
timeFrame: one year
Secondary outcomes:
measure: Percentage of Patients With Clinically Significant Voice Handicap Index-10 (VHI-10).
timeFrame: one year
measure: Mean Neck Disability Index (NDI)
timeFrame: one year
Other outcomes:
measure: Median Visual Analogue Scale for Neck Pain
timeFrame: one year
Locations:
city: Omaha
country: United States
facility: University of Nebraska Medical Center, Lauritzen Outpatient Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Kevin Garvin, MD
role: STUDY_CHAIR
References: