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

Dysphagia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04650893
• Other study ID #: 0737-19-FB
• Status: Recruiting
• Phase: Phase 3
• Start date: January 2, 2021
• Est. completion date: February 1, 2024

Study information

• Verified date: September 2023
• Source: University of Nebraska
• Contact: Scott A Vincent, MD
• Phone: 402-559-9171
• Email: scott.vincent[@]unmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: February 1, 2024
• Est. primary completion date: January 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

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

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia
• Dysphonia
• Hoarseness

Intervention

Drug:
• Intravenous Ketorolac
To assess the efficacy of the meds for dysphagia and dysphonia following ACDF
• Intravenous Dexamethasone
To assess the efficacy of the meds for dysphagia and dysphonia following ACDF
• Placebo
Control

Locations

Country	Name	City	State
United States	University of Nebraska Medical Center, Lauritzen Outpatient Center	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
University of Nebraska

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Median Visual Analouge Scale for Neck Pain	The Visual analogue scale is a 10 cm horizontal line, with extremes marked "no pain" (left) and the "worst pain imaginable" (right).	one year
Primary	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
Primary	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	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
Secondary	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