Stellate Ganglion Block in Bulbar Palsy

Copka Sonpashan

Status: Completed

Conditions: Bulbar Palsy

Treatments: Drug: Lidocaine Hydrochloride; Procedure: Stellate ganglion block; Behavioral: Comprehensive rehabilitation; Behavioral: placebo injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06319534

SGB-ZHENQIU

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 in 3 hospitals in China. 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, ultrasound diagnostic devices, and penetration-aspiration 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 in 3 hospitals in China. 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, ultrasound diagnostic devices, Flexible laryngoscope are used to assess swallowing function.

Enrollment: 124 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.
• Age >18 years.
• First-time stroke.
• Steady vital signs,
• Transferred or admitted to the Department of Rehabilitation Medicine within 15-30d after onset.
• No cognitive impairment or aphasia, with the Montreal Cognitive Assessment score ≥21 points.
• No history of severe mental illness or psychotropic drug dependence.
• Unsafe or insufficient oral intake, indicating the need for enteral feeding

Exclusion criteria

• Contraindications for Stellate Ganglion Block..
• Structural abnormalities of the oropharynx.
• 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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124 participants in 2 patient groups, including a placebo group

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:

Behavioral: Comprehensive rehabilitation

Procedure: Stellate ganglion block

Drug: Lidocaine Hydrochloride

Comprehensive rehabilitation+placebo

Placebo 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: placebo injection

Behavioral: Comprehensive rehabilitation