Effect of Local Intraoperative Steroid on Dysphagia After ACDF

Phase 3

Completed

• Conditions: Dysphagia
• Interventions: Drug: Dexamethasone; Drug: Methylprednisolone

• Registration Number: NCT03311425
• Lead Sponsor: Rush University Medical Center

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.

Study Timeline

• Study Start: 2014-08-01
• Primary Completion: 2017-06-27
• Study First Submitted: 2017-10-09
• Study First Submitted QC: 2017-10-11
• Study First Posted: 2017-10-17
• Study Completion: 2019-07-20
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-18
• Last Update Posted: 2020-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 140

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IV dexamethasone	Dexamethasone	Intraoperative systemic (IV) steroid (dexamethasone) only.
Local Depomedrol plus IV dexamethasone	Dexamethasone	Local intraoperative application of methylprednisolone (Depomedrol) plus standard systemic (IV) dexamethasone
Local Depomedrol plus IV dexamethasone	Methylprednisolone	Local intraoperative application of methylprednisolone (Depomedrol) plus standard systemic (IV) dexamethasone

Primary Outcome Measures

Name	Time	Method
Change from baseline SWAL-QOL survey at 3 months	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 Outcome Measures

Name	Time	Method
Change from Baseline Prevertebral Soft Tissue Swelling at 3 months	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.
Adverse Events	1 year	Any perioperative or postoperative adverse events will be recorded and evaluated between cohorts