The Effects of Intraoperative Local and Systemic Corticosteroid Administration on Postoperative Dysphagia After Anterior Cervical Fusion
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 140
- 主要终点
- Change from baseline SWAL-QOL survey at 3 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Allergies or other contraindications to medicines in the protocol including:
- •(a) Existing history gastrointestinal bleeding
- •Existing history of dysphagia
- •Current Smokers
- •Cervical spine trauma
研究组 & 干预措施
Local Depomedrol plus IV dexamethasone
Local intraoperative application of methylprednisolone (Depomedrol) plus standard systemic (IV) dexamethasone
干预措施: Methylprednisolone (Drug)
Local Depomedrol plus IV dexamethasone
Local intraoperative application of methylprednisolone (Depomedrol) plus standard systemic (IV) dexamethasone
干预措施: Dexamethasone (Drug)
IV dexamethasone
Intraoperative systemic (IV) steroid (dexamethasone) only.
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Change from baseline SWAL-QOL survey at 3 months
时间窗: 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.
次要结局
- Change from Baseline Prevertebral Soft Tissue Swelling at 3 months(3 months)
- Adverse Events(1 year)
研究者
Kern Singh
Professor of Orthopaedic Surgery
Rush University Medical Center