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Clinical trial

A Randomized Controlled Study to Explore The Effect of Stellate Ganglion Block in Cerebral Palsy and Dysphagia

ID
Name
SGB-NT
Description
The goal of this clinical trial is to test the efficacy of stellate ganglion block in children with cerebral palsy and dysphagia. The main question it aims to answer are: • Can stellate ganglion block improve the dysphagia of children with cerebral palsy? Participants were randomly divided into two groups, all provided with routine therapy. Based on this, the experimental group was given stellate ganglion block. The video fluoroscopic swallowing study was done to test the swallowing function before and after the study.
Trial arms
Trial start
2024-03-01
Estimated PCD
2024-12-01
Trial end
2024-12-01
Status
Not yet recruiting
Treatment
routine rehabilitation treatment
All participants were given routine rehabilitation treatment by professional rehabilitation therapists, including exercise therapy, guided education, psychological therapy, acupuncture and massage therapy, to promote the development of motor and cognitive function, as well as to improve intellectual development\[. Besides, swallowing function training was also provided, including direct training, indirect training, and compensatory training.
Arms:
routine rehabilitation treatment+Placebo, routine rehabilitation treatment+Stellate ganglion block
Stellate ganglion block
The patients were provided with Stellate ganglion block , using 0.5ml 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:
routine rehabilitation treatment+Stellate ganglion block
Lidocaine hydrochloride
The patients were provided with Stellate ganglion block , using 0.5ml 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. Once a day.
Arms:
routine rehabilitation treatment+Stellate ganglion block
Placebo injection
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. 1 milliliter of normal saline will be used for injection.
Arms:
routine rehabilitation treatment+Placebo
Size
80
Primary endpoint
Penetration-Aspiration Scale
day 1 and day 10
Eligibility criteria
Inclusion Criteria: * meeting the diagnostic criteria of cerebral palsy formulated by the 13th National Conference on Pediatric Cerebral Palsy Rehabilitation; * age between 4 to 7 years; * diagnosed as dysphagia confirmed by Dysphagia Disorder Survey or pediatric esophagoscopy; Exclusion Criteria: * with dysphagia caused by other diseases or factors; * with progressive neurological disease or degenerative neurological disease; * with severe heart disease, liver or kidney dysfunction, hematological disorders, or other acute and severe symptoms; * with abnormalities in the oral cavity, pharynx, esophagus, or other parts of the digestive tract; * with poor compliance.
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
Cerebral Palsy