Clinical trial
A Random Controlled Study to Explore the Effect of Stellate Ganglion Block on Post-Stroke Pharyngeal Dysphagia
Name
2022-KY-0049-002
Description
This was a multicenter randomized controlled study. 66 post-stroke patients with pharyngeal dysphagia were randomly allocated to the observation group (n=33) or the control group (n=33). 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, Kubota water swallowing test, video fluoroscopic swallowing study (VFSS), and Rosenbek penetration-aspiration scale (PAS) were used to assess swallowing function.
Trial arms
Trial start
2022-06-21
Estimated PCD
2023-05-02
Trial end
2023-05-17
Status
Terminated
Treatment
comprehensive rehabilitation
All the participants were 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.) and pharmacological treatment (aspirin, statins, anticoagulants, etc.).
Regrading swallowing function training, both groups were given swallowing function training, including 1) exercises of closure of the vocal folds, pharyngeal, and laryngeal muscles exercises, and respiratory muscle strength training, for 15 min each time and twice per day. 2) isotonic／isometric swallowing exercises, supraglottic swallowing exercises, and the Mendelsohn maneuver, for 20 min each time and twice per day. 3) effortful swallowing exercises, and cough reflex training, for 10 min each time and twice per day.
Arms:
The control group, The observation group
SGB
the observation group was given SGB once a day, with 10 sessions as a course of treatment and each side of the body for one course. All the materials included: 1) 1.5ml of 2% Lidocaine hydrochloride injection (1ml: 0.5mg), Vitamin B12 Injection 500ug (1ml: 0.5g), the 5 ml disposable syringe and the sterile disposable dental injection needles. The specific operation procedure was as follows\[16\]: The operator stood at the patient\'s block side, and the patient was placed in the supine position, with the head leaning 45 degrees toward the contralateral side of the block side. After routine disinfection of the skin, a paratracheal approach was adopted, which was, 2.5cm above the sternoclavicular joint and 1.5cm outside the midline of the neck.
Arms:
The observation group
Size
65
Primary endpoint
Video fluoroscopic swallowing study
day 1 and day 20
Eligibility criteria
Inclusion Criteria:
* Age between 30 and 80 years;
* New-onset stroke, confirmed by head CT or MRI;
* The course of disease between 1 to 6 months;
* With pharyngeal dysphagia shown by VFSS;
* Stable vital signs;
* Voluntary participation in the study.
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;
* With severe oral dysphagia (results of the VFSS oral phase as 2 or 3 points);
* Dysphagia caused by other diseases or reasons.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 65, 'type': 'ACTUAL'}}
Updated at
2024-03-05
1 organization
1 product
2 indications
Organization
Zeng ChanghaoProduct
SGBIndication
Difficulty swallowingIndication
Stellate Ganglion Block