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

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

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).

Study Overview

• Status: Terminated
• Conditions: Dysphagia; Dysphonia
• Intervention / Treatment: Drug: Placebo; Drug: Intravenous Ketorolac; Drug: Intravenous Dexamethasone

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.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68105
      • University of Nebraska Medical Center, Lauritzen Outpatient Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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)	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.	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. There are 10 sections, and each section contains 6 statements.The statements are scored from 0 to 5, with 0 indicating no disability and 5 indicating complete disability. 0: No disability or difficulty; Mild disability or difficulty; Moderate disability or difficulty; Severe disability or difficulty; Very severe disability or difficulty; Complete disability or difficulty Total Score: The scores from each of the 10 sections are summed to calculate the total score. The maximum possible score is 50, which would indicate severe disability, while a score of 0 indicates no disability.	one year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Median Visual Analogue Scale for Neck Pain	The Visual analogue scale is a line with numbers underneath it, with extremes marked "no pain" score of 0 (left) and the "worst pain imaginable" score of 10 (right).	one year

Collaborators and Investigators

• Sponsor: University of Nebraska
• Investigators: Study Chair: Kevin Garvin, MD, University of Nebraska

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2021
• Primary Completion (Actual): December 8, 2023
• Study Completion (Actual): December 8, 2023

Study Registration Dates

• First Submitted: November 12, 2020
• First Submitted That Met QC Criteria: December 2, 2020
• First Posted (Actual): December 3, 2020

Study Record Updates

• Last Update Posted (Actual): August 23, 2024
• Last Update Submitted That Met QC Criteria: August 20, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Neurologic Manifestations; Gastrointestinal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Signs and Symptoms, Respiratory; Esophageal Diseases; Laryngeal Diseases; Voice Disorders; Deglutition Disorders; Dysphonia; Hoarseness; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Dexamethasone; Ketorolac
• Other Study ID Numbers: 0737-19-FB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes