Clinical trial

A Randomized Controlled Study to Explore the Effect of Stellate Ganglion Block in Dysphagic Patients With Bulbar Palsy After Ischemic Stroke

NCT06319534

Name

SGB-ZHENQIU

Description

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, Functional Oral Intake Scale, Flexible laryngoscope are used to assess swallowing function.

Trial arms

Trial start

2024-03-01

Estimated PCD

2024-12-01

Trial end

2024-12-01

Status

Not yet recruiting

Treatment

Comprehensive rehabilitation

All the participants are provided with the comprehensive rehabilitation (routine rehabilitation and swallowing function training). The routine rehabilitation included intervention for risk factors (blood pressure, blood lipids, blood glucose, smoking and alcohol restriction, exercise, etc.).

Arms:

Comprehensive rehabilitation+Stellate ganglion block, Comprehensive rehabilitation+placebo

Stellate ganglion block

The percutaneous approach via the paratracheal route was used for Stellate ganglion block. The operator stood on the side of the block, instructed the patient to lie supine with a thin pillow placed below the shoulders, and tilted the head 45° towards the blocked side, fully exposing the neck. Then, routine disinfection of the neck skin was performed. The puncture site was located 2.5 cm above the sternoclavicular joint and 1.5 cm lateral to the midline of the neck.

Arms:

Comprehensive rehabilitation+Stellate ganglion block

Lidocaine Hydrochloride

the patients are provided with Stellate ganglion block, using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g). The percutaneous approach via the paratracheal route was used for Stellate ganglion block. The operator stood on the side of the block, instructed the patient to lie supine with a thin pillow placed below the shoulders, and tilted the head 45° towards the blocked side, fully exposing the neck. Then, routine disinfection of the neck skin was performed. The puncture site was located 2.5 cm above the sternoclavicular joint and 1.5 cm lateral to the midline of the neck.

Arms:

Comprehensive rehabilitation+Stellate ganglion block

placebo injection

1 milliliter of normal saline will be used for injection. The percutaneous approach via the paratracheal route was used for Stellate ganglion block. The operator stood on the side of the block, instructed the patient to lie supine with a thin pillow placed below the shoulders, and tilted the head 45° towards the blocked side, fully exposing the neck. Then, routine disinfection of the neck skin was performed. The puncture site was located 2.5 cm above the sternoclavicular joint and 1.5 cm lateral to the midline of the neck.

Arms:

Comprehensive rehabilitation+placebo

Size

Primary endpoint

Penetration-Aspiration Scale

day 1 and day 10

Eligibility criteria

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. * 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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 80, 'type': 'ESTIMATED'}}

Updated at

2024-03-20

1 organization

1 product

1 indication

Organization

Copka Sonpashan

Product

Lidocaine

Indication

Bulbar Palsy