Stellate Ganglion Block: A Breakthrough Treatment for Post-Stroke Pharyngeal Dysphagia (SGB)

Zeng Changhao

Status: Terminated

Conditions: Stellate Ganglion Block; Dysphagia

Treatments: Drug: SGB; Behavioral: comprehensive rehabilitation

Study type: Interventional

Funder types: Other

Identifiers

NCT06189560

2022-KY-0049-002

Details and patient eligibility

About

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.

Full description

Dysphagia is a frequent and potentially serious complication of stroke. However, there is no effective measure for the treatment of pharyngeal dysphagia in stroke patients. This study aims to explore the efficacy of stellate ganglion block in post-stroke pharyngeal dysphagic patients who received comprehensive rehabilitation. 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.

Enrollment: 65 patients

Sex: All

Ages: 30 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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65 participants in 2 patient groups

The observation group

Experimental group

Description:

Patients enrolled were firstly numbered for privacy with software and divided into the observation group (n=33) and the control group (n=33) with a random number table. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasted 20 days.

Treatment:

Drug: SGB

Behavioral: comprehensive rehabilitation

The control group

Active Comparator group

Description:

Patients enrolled were firstly numbered for privacy with software and divided into the observation group (n=33) and the control group (n=33) with a random number table. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasted 20 days.

Treatment:

Behavioral: comprehensive rehabilitation