Stellate Ganglion Block in Bulbar Palsy
A Randomized Controlled Study to Explore the Effect of Stellate Ganglion Block in Dysphagic Patients With Bulbar Palsy After Ischemic Stroke
1 other identifier
interventional
124
1 country
6
Brief Summary
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, ultrasound diagnostic devices, and penetration-aspiration scale, Flexible laryngoscope are used to assess swallowing function.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Mar 2024
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 10, 2024
CompletedFirst Posted
Study publicly available on registry
March 20, 2024
CompletedStudy Start
First participant enrolled
March 23, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 5, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 5, 2025
CompletedJuly 10, 2025
July 1, 2025
1.2 years
March 10, 2024
July 6, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Modified Barium Swallow Impairment Profile
The Modified Barium Swallow Impairment Profile is used to evaluate the clinical severity of dysphagia. It consisted of 17 items. The total scores could range between 0 and 55, with higher scores indicating worse function.
day 1 before any intervention, day 11, and day 60
Secondary Outcomes (7)
Murray secretion severity scale
day 1 before any intervention, day 11, and day 60
Yale pharyngeal residue severity rating scale
day 1 before any intervention, day 11, and day 60
Penetration-Aspiration Scale
day 1 before any intervention, day 11, and day 60
Generalized Anxiety Disorder 7-item scale
day 1 before any intervention, day 11, and day 60
Movement distances of the hyoid bone
day 1 before any intervention, day 11, and day 60
- +2 more secondary outcomes
Study Arms (2)
Comprehensive rehabilitation+Stellate ganglion block
EXPERIMENTALPatients enrolled are firstly numbered for privacy with software and divided into the observation group and the control group with. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasts 10 days.
Comprehensive rehabilitation+placebo
PLACEBO COMPARATORPatients enrolled are firstly numbered for privacy with software and divided into the observation group and the control group with. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasts 10 days.
Interventions
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.).
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. The ultrasonic instrument is used to determine the position.
the patients are provided with Stellate ganglion block, using 2.8ml of 0.8% Lidocaine hydrochloride and 0.2 ml of 0.5% vitamin B12. 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. The ultrasonic instrument is used to determine the position.
2.8 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. The ultrasonic instrument is used to determine the position.
Eligibility Criteria
You may qualify if:
- Diagnosed with ischemic stroke according to the diagnostic criteria, with the stroke occurring in the medulla oblongata and diagnosed as bulbar palsy.
- Age \>18 years.
- First-time stroke.
- Steady vital signs,
- Transferred or admitted to the Department of Rehabilitation Medicine within 15-30d after onset.
- No cognitive impairment or aphasia, with the Montreal Cognitive Assessment score ≥21 points.
- No history of severe mental illness or psychotropic drug dependence.
- Unsafe or insufficient oral intake, indicating the need for enteral feeding
You may not qualify if:
- Contraindications for Stellate Ganglion Block..
- Structural abnormalities of the oropharynx.
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Copka Sonpashanlead
Study Sites (6)
zhongshan affiliated No.1 Hospital
Guandong, China
HLJ older people hospital
Heilongjiang, China
Lankao Renmen Hospital
Henan, China
NY zhongxin Hospital
Naning, China
People's Hospital of SN tequ
Suzhu, China
Department of rehabilitation medicine, the first ZU hospital north campus
Zhenzhou, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Nieto Luis
Site Coordinator of United Medical Group
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Research Director
Study Record Dates
First Submitted
March 10, 2024
First Posted
March 20, 2024
Study Start
March 23, 2024
Primary Completion
June 5, 2025
Study Completion
July 5, 2025
Last Updated
July 10, 2025
Record last verified: 2025-07