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Clinical trial

Effect of Stellate Ganglion Block in Dysphagic Patients With Bulbar Palsy After Ischemic Stroke

ID
Name
wallenburg sym
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 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.
Trial arms
Trial start
2022-01-01
Estimated PCD
2023-05-04
Trial end
2023-05-28
Status
Completed
Treatment
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:
Stellate Nerve Block+ routine rehabilitation treatment
Lidocaine Hydrochloride
the patients were provided with Stellate ganglion block, using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g)
Arms:
Stellate Nerve Block+ routine rehabilitation treatment
Comprehensive therapy
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:
Stellate Nerve Block+ routine rehabilitation treatment, placebo+routine rehabilitation treatment
placebo
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. Only normal saline was used
Arms:
placebo+routine rehabilitation treatment
Size
122
Primary endpoint
Functional Oral Intake 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. * 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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 122, 'type': 'ACTUAL'}}
Updated at
2024-03-28

1 organization

1 product

1 indication

Organization
Copka Sonpashan
Product
Lidocaine
Indication
Difficulty swallowing