Stellate Ganglion Block in Bulbar Palsy

Not Applicable

Completed

• Conditions: Bulbar Palsy
• Interventions: Behavioral: Comprehensive rehabilitation; Procedure: Stellate ganglion block; Behavioral: placebo injection; Drug: Lidocaine Hydrochloride

• Registration Number: NCT06319534
• Lead Sponsor: Copka Sonpashan

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.

Detailed Description

Palliation of dysphagia in patients with bulbar palsy after ischemic stroke continues to be a challenge.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, ultrasound diagnostic devices, Flexible laryngoscope are used to assess swallowing function.

Study Timeline

• Study First Submitted: 2024-03-10
• Study First Submitted QC: 2024-03-19
• Study First Posted: 2024-03-20
• Study Start: 2024-03-23
• Primary Completion: 2025-06-05
• Status Verified: 2025-07
• Study Completion: 2025-07-05
• Last Update Submitted: 2025-07-06
• Last Update Posted: 2025-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comprehensive rehabilitation+Stellate ganglion block	Comprehensive rehabilitation	Patients 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+Stellate ganglion block	Stellate ganglion block	Patients 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+Stellate ganglion block	Lidocaine Hydrochloride	Patients 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	Comprehensive rehabilitation	Patients 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 injection	Patients 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.

Primary Outcome Measures

Name	Time	Method
Modified Barium Swallow Impairment Profile	day 1 before any intervention, day 11, and day 60	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.

Secondary Outcome Measures

Name	Time	Method
Murray secretion severity scale	day 1 before any intervention, day 11, and day 60	Murray secretion severity scale is used for assessment of Pharyngeal secretion. The result was divided into 0-3 levels (0, normal; 1, a small amount of secretion remained and not entering the laryngeal vestibule; 2: temporary accumulation in the laryngeal vestibule; 3: persistent accumulation in the laryngeal vestibule. A higher score indicates the worse dysphagia.
Yale pharyngeal residue severity rating scale	day 1 before any intervention, day 11, and day 60	The Yale pharyngeal residue severity rating scale was recruited for assessment of Pharyngeal residue.The result would be divided into 5 levels (1, no residue; 2, the covered pharyngeal mucosa; 3, mild residue, less than 50%; 4, moderate residue, more than 50%; 5, severe residue, spillage from laryngeal vestibule observed). A higher score indicates the worse dysphagia.
Penetration-Aspiration Scale	day 1 before any intervention, day 11, and day 60	Penetration-Aspiration Scale was used to assess dysphagia under Videofluoroscopic Swallowing Study, primarily evaluating the extent to which fluid food entered the airway and caused penetration or aspiration during the swallowing process. As the level increased, the severity of dysphagia also increased.
Generalized Anxiety Disorder 7-item scale	day 1 before any intervention, day 11, and day 60	Generalized Anxiety Disorder 7-item scale was used to assess anxiety.The total score could range from 0 to 21, with higher scores indicating more severe anxiety.
Movement distances of the hyoid bone	day 1 before any intervention, day 11, and day 60	The lateral swallowing fluorography record was decomposed into individual images. Images were selected at both the resting positions and the maximum displacement. The distance of position change for the hyoid bone between the two images was measured with the inferior border of the C4 vertebra as a reference point. Then, the average movement distance was calculated and adopted.
Vertebral artery cerebral blood flow velocity	day 1 before any intervention, day 11, and day 60	The ultrasound diagnostic device was used to measure the internal diameter of the vertebral artery. The sample volume was then positioned at the center of the vessel and the angle between the ultrasound beam and the blood flow direction was kept within 60°. The Color Doppler ultrasound examination was performed to measure the mean blood flow velocity of the vertebral artery by continuously observing 10 cycles.
Vertebral artery internal diameter	day 1 before any intervention, day 11, and day 60	The ultrasound diagnostic device was used to measure the internal diameter of the vertebral artery. The sample volume was then positioned at the center of the vessel and the angle between the ultrasound beam and the blood flow direction was kept within 60°.

Trial Locations

Locations (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