Effect of Local Steroid Application on a Cervical Plate Versus Intravenous Steroids on Dysphagia Following Anterior Cervical Discectomy and Fusion (ACDF)
Condition: Cervical Spine
MeSH terms: Deglutition Disorders
Study type: Interventional

Summary: 
      Local application of steroids in ACDF surgery will lead to decreased incidence of dysphagia
      compared to intravenous steroids or a control group
    

Detailed description: 
      Dysphagia is a common complication after ACDF. PSTS is also a natural sequela of ACDF and can
      lead to airway compromise among other complications. Previous studies have demonstrated that
      administration of intravenous methylprednisolone (1mg/kg) after anterior cervical spine
      surgery reduced the incidence of pharyngolaryngeal lesions as identified by nasofibroscopic
      examination. Lee et al. prospectively evaluated 50 patients and determined that local
      application of steroids in the retropharyngeal area following ACDF reduced PSTS and
      odynophagia as measured by the Visual Analogue Scale (VAS) and the Neck Disability Index
      (NDI) compared to a control group. Furthermore, there were no adverse events/reactions from
      local application of steroid on a gel foam sponge in the setting of anterior spinal surgery.
      There are no studies in the current literature that investigate the incidence of dysphagia
      with application of local steroids after ACDF, nor are there any studies that stratify the
      efficacy of local steroids compared to intravenous steroids. There is also no current spine
      literature that directly compares the efficacy of intravenous steroids versus local steroids
      in the incidence of dysphagia or dysphonia. Our study will be the first in the literature to
      assess the efficacy of local steroids in reducing the incidence of dysphagia after anterior
      cervical spine surgery, and as a result, may improve patient outcomes after ACDF.

      Dysphagia and dysphonia are common complications after anterior cervical spine surgery.
      Despite their clinical importance, studies on the treatment and/or prevention of these
      complications are limited due to the lack of valid and reliable outcome measures. The
      majority of research is found in the otolaryngology literature and has focused on disease
      pathophysiology, diagnosis, and therapy.

      The Bazaz score has been used in the spine literature to evaluate dysphagia after anterior
      cervical discectomy and fusion (ACDF). This is a subjective questionnaire that has not been
      validated in the literature. Additionally, new patient-centered outcome measures, the Eating
      Assessment Tool (EAT-10) and Voice Handicap Index (VHI-10) have recently been developed, and
      in addition to the Bazaz score, have been shown to have excellent validity and reliability in
      the ENT patient population. These instruments can be used to document the initial dysphagia
      or dysphonia severity and monitor the treatment response in people with a wide array of
      swallowing and voice disorders.
    

Intervention name(s): Decadron; Triamcinolone
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate; 40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate
Intervention MeSH terms: Triamcinolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment