Clinical trial NCT03311425: Effect of Local Intraoperative Steroid on Dysphagia After ACDF
Official title: The Effects of Intraoperative Local and Systemic Corticosteroid Administration on Postoperative Dysphagia After Anterior Cervical Fusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dysphagia
Keywords: Anterior cervical discectomy and fusion
prevertebral swelling
swallowing
methylprednisolone
intraoperative steroid
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2017-10-17
Enrollment: 140
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Change from baseline SWAL-QOL survey at 3 months
timeFrame: 3 months
Secondary outcomes:
measure: Change from Baseline Prevertebral Soft Tissue Swelling at 3 months
timeFrame: 3 months
measure: Adverse Events
timeFrame: 1 year
Other outcomes:
Locations:
Study officials:
affiliation: Rush University Medical Center
name: Kern Singh, MD
role: PRINCIPAL_INVESTIGATOR
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