A Double-blind Randomized Controlled Study to Explore Effectiveness of Stellate Ganglion Block in Managing Dysphagia in Patients With Medullary Infarction
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 主要终点
- Penetration-Aspiration Scale
研究概览
简要总结
This is a randomized controlled study, including dysphagic patients with bulbar palsy after ischemic stroke who were received in the department of rehabilitation medicine. All patients are randomly allocated to the observation group or the control group. Both groups are provided with comprehensive rehabilitation. Besides, the observation group additionally undergoes the stellate ganglion block. At admission and after 10-day treatment, video fluoroscopic swallowing study, and penetration-aspiration scale, Functional Oral Intake Scale, Flexible laryngoscope are used to assess swallowing function.
详细描述
Palliation of dysphagia in patients with bulbar palsy after ischemic stroke continues to be a challenge. This is a randomized controlled study, including dysphagic patients with bulbar palsy after ischemic stroke who were received in the department of rehabilitation medicine. All patients are randomly allocated to the observation group or the control group. Both groups are provided with comprehensive rehabilitation. Besides, the observation group additionally undergoes the stellate ganglion block. At admission and after 10-day treatment, video fluoroscopic swallowing study, and penetration-aspiration scale, Functional Oral Intake Scale, Flexible laryngoscope are used to assess swallowing function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with ischemic stroke according to the diagnostic criteria, with the stroke occurring in the medulla oblongata and diagnosed as bulbar palsy.
- •Upper Esophageal Sphincter did not open or opened ineffectively, with food residue or aspiration, revealed by Videofluoroscopic Swallow Study.
- •Age >18 years.
- •First-time stroke.
- •Steady vital signs,
- •Transferred or admitted to the Department of Rehabilitation Medicine within 15d after onset.
排除标准
- •The bulbar palsy caused by other diseases, such as neurodegenerative diseases.
- •Pseudobulbar palsy.
- •Complicated with other neurological diseases.
- •Tracheostomy tube inserted.
- •Simultaneously suffering from liver, kidney failure, tumors, or hematological diseases.
- •Dysphagia caused by other possible diseases.
- •Pregnant females.
研究组 & 干预措施
Comprehensive rehabilitation+Stellate ganglion block
Patients enrolled are firstly numbered for privacy with software and divided into the observation group and the control group with. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasts 10 days.
干预措施: Comprehensive rehabilitation (Behavioral)
Comprehensive rehabilitation+Stellate ganglion block
Patients enrolled are firstly numbered for privacy with software and divided into the observation group and the control group with. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasts 10 days.
干预措施: Injection (Procedure)
Comprehensive rehabilitation+Stellate ganglion block
Patients enrolled are firstly numbered for privacy with software and divided into the observation group and the control group with. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasts 10 days.
干预措施: Lidocaine Hydrochloride (Drug)
Comprehensive rehabilitation
Patients enrolled are firstly numbered for privacy with software and divided into the observation group and the control group with. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasts 10 days.
干预措施: Comprehensive rehabilitation (Behavioral)
Comprehensive rehabilitation
Patients enrolled are firstly numbered for privacy with software and divided into the observation group and the control group with. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasts 10 days.
干预措施: Injection (Procedure)
结局指标
主要结局
Penetration-Aspiration Scale
时间窗: day 1 and day 10
Penetration-Aspiration Scale was used to assess dysphagia under Videofluoroscopic Swallowing Study, primarily evaluating the extent to which fluid food entered the airway and caused penetration or aspiration during the swallowing process. As the level increased, the severity of dysphagia also increased.
次要结局
- Murray secretion severity scale(day 1 and day 10)
- Yale pharyngeal residue severity rating scale(day 1 and day 10)
- Functional Oral Intake Scale(day 1 and day 10)
研究者
Muhammad
Research Director
Ahmadu Bello University Teaching Hospital