Effect of Local Intraoperative Steroid on Dysphagia After ACDF

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Dysphagia

Intervention / Treatment
-----------------
* Drug: Methylprednisolone
* Drug: Dexamethasone


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Local Depomedrol plus IV dexamethasone<br>Local intraoperative application of methylprednisolone (Depomedrol) plus standard systemic (IV) dexamethasone | Drug: Methylprednisolone<br>* Application of 40mg Depomedrol (methylprednisolone acetate) suspension into the retropharyngeal space prior to incision closure<br>Drug: Dexamethasone<br>* Administration of 10mg Dexamethasone IV intraoperatively<br>|
| Placebo Comparator: IV dexamethasone<br>Intraoperative systemic (IV) steroid (dexamethasone) only. | Drug: Dexamethasone<br>* Administration of 10mg Dexamethasone IV intraoperatively<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline SWAL-QOL survey at 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. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Prevertebral Soft Tissue Swelling at 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. | 3 months | 
| Adverse Events | Any perioperative or postoperative adverse events will be recorded and evaluated between cohorts | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anterior cervical discectomy and fusion, prevertebral swelling, swallowing, methylprednisolone, intraoperative steroid