Effect of Local Intraoperative Steroid on Dysphagia After ACDF

Rush

Status and phase: Completed; Phase 3

Conditions: Dysphagia

Treatments: Drug: Methylprednisolone; Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT03311425

13092002

Details and patient eligibility

About

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.

Full 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.

Enrollment: 140 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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140 participants in 2 patient groups, including a placebo group

Local Depomedrol plus IV dexamethasone

Active Comparator group

Description:

Local intraoperative application of methylprednisolone (Depomedrol) plus standard systemic (IV) dexamethasone

Treatment:

Drug: Dexamethasone

Drug: Methylprednisolone

IV dexamethasone

Placebo Comparator group

Description:

Intraoperative systemic (IV) steroid (dexamethasone) only.

Treatment:

Drug: Dexamethasone