The Effectiveness of Stellate Ganglion Block in Managing Dysphagia in Patients With Medullary Infarction

Ahmadu Bello University Teaching Hospital

Status: Not yet enrolling

Conditions: Bulbar Palsy

Treatments: Behavioral: Comprehensive rehabilitation; Procedure: Injection; Drug: Lidocaine Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT06301698

SGB-BP

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups

Comprehensive rehabilitation+Stellate ganglion block

Experimental group

Description:

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.

Treatment:

Drug: Lidocaine Hydrochloride

Behavioral: Comprehensive rehabilitation

Procedure: Injection

Comprehensive rehabilitation

Active Comparator group

Description:

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.

Treatment:

Behavioral: Comprehensive rehabilitation

Procedure: Injection