NCT06319534

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 124 (actual)
• Sponsor: Copka Sonpashan · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bulbar Palsy

Interventions

Type	Name	Description
BEHAVIORAL	Comprehensive rehabilitation	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.).
PROCEDURE	Stellate ganglion block	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.
DRUG	Lidocaine Hydrochloride	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.
BEHAVIORAL	placebo injection	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.

Timeline

• Start date: 2024-03-23
• Primary completion: 2025-06-05
• Completion: 2025-07-05
• First posted: 2024-03-20
• Last updated: 2025-07-10

Locations

6 sites across 1 country: China