Effect of Stellate Nerve Block in Dysphagia

Copka Sonpashan

Status: Completed

Conditions: Dysphagia

Treatments: Drug: Lidocaine Hydrochloride; Behavioral: placebo; Procedure: Injection; Behavioral: Comprehensive therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06335316

wallenburg sym

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 China. Both groups were provided with comprehensive rehabilitation including routine rehabilitation and swallowing function training. Besides, the observation group additionally underwent the stellate ganglion block (SGB). At admission and after 20-day treatment,Yale Pharyngeal Residue Severity Rating Scale, video fluoroscopic swallowing study (VFSS), Functional Oral Intake Scale, and penetration-aspiration scale (PAS) were used to assess swallowing function.

Full description

Dysphagia is a frequent and potentially serious complication of stroke. 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 China. Both groups were provided with comprehensive rehabilitation including routine rehabilitation and swallowing function training. Besides, the observation group additionally underwent the stellate ganglion block (SGB). At admission and after 20-day treatment,Yale Pharyngeal Residue Severity Rating Scale, video fluoroscopic swallowing study (VFSS), Functional Oral Intake Scale, and penetration-aspiration scale (PAS) were used to assess swallowing function.

Enrollment: 122 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.
• Dysphagia.
• Age >18 years.
• First-time stroke.
• Steady vital signs,
• Transferred or admitted to the Department of Rehabilitation Medicine within 15d after onset.

Exclusion criteria

• Allergy to Lidocaine injection or vitamin B12 injection;
• Severe cognitive impairment;
• Coagulation disorders;
• Severe dysfunction of organs including heart, lungs, kidney, liver, etc.;
• Complicated with other neurological diseases;
• Dysphagia caused by other diseases or reasons.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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122 participants in 2 patient groups, including a placebo group

Stellate Nerve Block+ routine rehabilitation treatment

Experimental group

Description:

The patients were given Nerve block and routine rehabilitation treatment for 10 days.

Treatment:

Procedure: Injection

Behavioral: Comprehensive therapy

Drug: Lidocaine Hydrochloride

placebo+routine rehabilitation treatment

Placebo Comparator group

Description:

The patients were given placebo block and routine rehabilitation treatment for 10 days.

Treatment:

Behavioral: placebo

Behavioral: Comprehensive therapy