Skip to main content
OpenTrials
Completed

NCT Number: NCT03311425

Effect of Local Intraoperative Steroid on Dysphagia After ACDF

The purpose of this study is to determine if the incidence and duration of postoperative dysphagia are improved in the participants receiving a local injection of methylprednisolone with systemic dexamethasone when compared to those receiving the usual systemic dexamethasone.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dysphagia Deglutition Disorders Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Otorhinolaryngologic Diseases Pharyngeal Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

About this study

Postoperative dysphagia is a known complication of anterior cervical spinal fusion (ACF) surgery with a published incidence that ranges from 1.7% to 50.3%.1-9 The pathophysiology of post-operative dysphagia is not fully understood and is subject to further study. Postoperative dysphagia has been reported to improve with time with a mean incidence of 19.8% at 6 months, 16.8% at 12 months, and 12.9% at 24 months after ACDF. The investigator's standard of practice is to provide 10mg of dexamethasone IV intraoperatively in order to reduce postoperative prevertebral soft tissue swelling. Despite the growing popularity of ACDF procedures, there is a lack of clear evidence supporting the utilization of perioperative corticosteroids in the setting of an ACDF.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing a primary 1- to 3-level ACDF:

(a) Diagnosis: myelopathy, radiculopathy, myeloradiculopathy, stenosis, herniated nucleus pulposus, degenerative disc disease, spondylosis, osteophytic complexes, and foraminal stenosis

  • Patients able to provide informed consent

Exclusion criteria

  • Allergies or other contraindications to medicines in the protocol including:

(a) Existing history gastrointestinal bleeding

  • Existing history of dysphagia
  • Current Smokers
  • Cervical spine trauma

Treatment and study plan

methylprednisolone

Drug

Application of 40mg Depomedrol (methylprednisolone acetate) suspension into the retropharyngeal space prior to incision closure

Dexamethasone

Drug

Administration of 10mg Dexamethasone IV intraoperatively

Primary outcomes

  1. Change from baseline SWAL-QOL survey at 3 months

    Time frame: 3 months

    In the postoperative period, patients will be asked to complete the SWAL-QOL survey at the 3 month follow up office visit. This will be compared to preoperative scores. Each survey is scored out of 100 with minimum score of 20 indicating severe dysphagia and 100 indicating no dysphagia/normal swallowing. As such, a greater decrease in SWAL-QOL score from preoperative (baseline) to 3 month visit indicates greater postoperative swallowing difficulty.

Secondary outcomes

  1. Change from Baseline Prevertebral Soft Tissue Swelling at 3 months

    Time frame: 3 months

    Prevertebral soft tissue swelling will be measured utilizing the standard of practice plain lateral radiographs that are obtained at the 3 month postoperative follow up office visit.The area of the prevertebral soft tissue density will be measured from the caudal border of C1 to the cranial end plate of C7 with a digital measuring instrument. These measurements will be compared to the preoperative measurements obtained utilizing the preoperative lateral plain radiographs which are also standard of practice.

  2. Adverse Events

    Time frame: 1 year

    Any perioperative or postoperative adverse events will be recorded and evaluated between cohorts

Sponsors and collaborators

Lead sponsor

Rush University Medical Center

Other

Registry information

Official study title

The Effects of Intraoperative Local and Systemic Corticosteroid Administration on Postoperative Dysphagia After Anterior Cervical Fusion

Important dates

Study start
2014
Primary completion
2017
Study completion
2019
First posted
Oct 17, 2017
Registry last updated
Nov 20, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.