The Effects of Intraoperative Local and Systemic Corticosteroid Administration on Postoperative Dysphagia After Anterior Cervical Fusion
Overview
- Phase
- Phase 3
- Intervention
- Methylprednisolone
- Conditions
- Dysphagia
- Sponsor
- Rush University Medical Center
- Enrollment
- 140
- Primary Endpoint
- Change from baseline SWAL-QOL survey at 3 months
- Status
- Completed
- Last Updated
- 5 years ago
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.
Investigators
Kern Singh
Professor of Orthopaedic Surgery
Rush University Medical Center
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
Arms & Interventions
Local Depomedrol plus IV dexamethasone
Local intraoperative application of methylprednisolone (Depomedrol) plus standard systemic (IV) dexamethasone
Intervention: Methylprednisolone
Local Depomedrol plus IV dexamethasone
Local intraoperative application of methylprednisolone (Depomedrol) plus standard systemic (IV) dexamethasone
Intervention: Dexamethasone
IV dexamethasone
Intraoperative systemic (IV) steroid (dexamethasone) only.
Intervention: Dexamethasone
Outcomes
Primary Outcomes
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
- Change from Baseline Prevertebral Soft Tissue Swelling at 3 months(3 months)
- Adverse Events(1 year)