A Random Controlled Study to Explore the Effect of Stellate Ganglion Block on Post-Stroke Pharyngeal Dysphagia
Phase: NA
Conditions: Dysphagia, Stellate Ganglion Block
Sponsor: Zeng Changhao

                   
 
1 
Stellate Ganglion Block: A Breakthrough Treatment for Post-Stroke Pharyngeal 
Dysphagia 
 
Plan number 
 
Version 
V1.0 
Date 
Research unit 
2021.12.10 
Department of Rehabilitation Medicine, 
The First Affiliated Hospital of Zhengzhou 
University 
Main Researchers 
Zengxi 
Research responsible unit The First Affiliated Hospital of Zhengzhou 
University 
Applicant 
Department of Rehabilitation Medicine, 
The First Affiliated Hospital of Zhengzhou 
University 
 
 
Statement 
This trial protocol is confidential and intended for distribution to medical experts, researchers 
involved in the trial, and other staff members associated with the trial, as well as the medical 
institutions, ethics committees, and contracted research organizations involved in the trial. Except 
for providing information to the participants, no content of this trial protocol shall be disclosed or 
made available to any third party without prior written consent from the sponsor. Furthermore, any 
partial or complete results of this clinical trial, when published externally in societies, journals, 
etc., require written consent from the sponsor. 
 

                   
 
2 
 
CATALOGUE 
Abstract ...................................................................................................... 3 
1、Background ......................................................................................... 5 
2、Objectiv ................................................................................................ 5 
3、Plan ....................................................................................................... 5 
4、Eligibility .............................................................................................. 5 
4.1 Inclusion criteria and exclusion criteria .......................................... 6 
4.2 Dropout and termination criteria ..................................................... 6 
4.3 Dropout and termination criteria .................................................... 6 
5、Management ........................................................................................ 7 
5.1 Ethnics and informed consent ......................................................... 7 
5.2 Protection ........................................................................................ 7 
5.3 Management unit ............................................................................ 8 
6、References ............................................................................................ 8 
Co-organizer 
N/A 

                
 
3 
Abstract 
Title 
Stellate Ganglion Block: A Breakthrough Treatment for 
Post-Stroke Pharyngeal Dysphagia 
 
Drugs 
N/A 
Approval 
number 
of durgs 
N/A 
Aims 
This study aims to explore the efficacy of stellate ganglion block in post-stroke 
pharyngeal dysphagic patients who received comprehensive rehabilitation. 
Design 
This was a randomized controlled study 
Indicatio
ns 
post-stroke patients with pharyngeal dysphagia 
Total 
cases 
65 post-stroke patients with pharyngeal dysphagia were randomly allocated to 
the observation group (n=33) or the control group (n=32). 
Center 
The First Affiliated Hospital of Zhengzhou University 
Research 
period 
2022.6-2023.6 
Case 
selection 
The inclusion criteria were: 1) Age between 30 and 80 years; 2) New-onset 
stroke, confirmed by head CT or MRI; 3) The course of disease between 1 to 6 
months; 4) With pharyngeal dysphagia shown by VFSS; 5) Stable vital signs; 6) 
Voluntary participation in the study. The exclusion criteria were: 1) Allergy to 
Lidocaine injection or vitamin B12 injection; 2) Severe cognitive impairment; 
3) Coagulation disorders; 4) Severe dysfunction of organs including heart, 
lungs, kidney, liver, etc.; 6) Complicated with other neurological diseases; 7) 
With severe oral dysphagia (results of the VFSS oral phase as 2 or 3 points); 8) 
Dysphagia caused by other diseases or reasons. 
Study 
drug 
N/A 

                
 
4 
Plan 
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.). 
Based on these, 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. 
Visit 
timing 
N/A 
Procedur
es 
From June 2022 to June 2023, we conducted a randomized controlled clinical 
study including 65 post-stroke patients with pharyngeal dysphagia who were 
transferred or admitted to the department of rehabilitation medicine of 3 
hospitals in China. 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.). 
 
Assessme
nt 
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. 
Safety 
indicator 
AEs 
 
 
1.Background 
Stroke refers to a pathological state characterized by the abnormal cerebral blood flow leading to 
the demise of brain cells[1]. It stands as the foremost cause of disability-adjusted life years (47.3%) 
and mortality (67.3%) among neurological diseases[2]. In China, the annual incidence of new 
strokes was estimated at approximately 2 million[3]. Moreover, owing to growth and ageing of 
population, the incidence of stroke has surged by 59.2%, while the rates of disability and mortality 
have escalated by 21.7% and 36.4%, respectively[4]. Stroke may manifest in motor dysfunction, 
sensory impairment, cognitive deficits, dysphagia, and various other symptoms, notably, among 
which, dysphagia represents a severe complication[5]. It was reported that approximately 60% of 
conscious acute stroke patients exhibited dysphagia, as evidenced by video fluoroscopic 
swallowing studies (VFSS)[6]. Stroke-related dysphagia refers to the impediment encountered in 
the transportation of food from the oral cavity to the stomach due to stroke, resulting in the 
inability to ingest sustenance safely and acquire adequate hydration as well as nutrition[7]. It 
should be notified that dysphagia is associated with airway obstruction, aspiration, pneumonia, 
dehydration, malnutrition, and, in extreme cases, mortality[8]. According to the previous study, the 
mortality rate among dysphagic patients at 30 days was 22.9%, as compared to 8.3% for 
non-dysphagic patients[9]. Furthermore, even during the subsequent one-year follow-up period, the 
mortality rate among dysphagic patients remains notably higher than that of their non-dysphagic 
counterparts[8]. 
According to the anatomical structures involved in the process of swallowing, the process of 
ingestion and swallowing can be categorized into the preparatory phase, oral phase, pharyngeal 
phase, and esophageal phase[10]. Depending on the specific location of brain stroke injury, patients 

                
 
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may present with varying types of dysphagia[11]. Pharyngeal dysphagia refers to the inability of 
patients to safely and effectively pass food through the pharynx, including delayed initiation of 
swallowing, repeated swallowing, coughing, hoarse voice, and aspiration[12]. Global guidelines 
from the World Gastrointestinal Organization indicate that within three days of a stroke, 42%-67% 
of the patients will experience oropharyngeal dysphagia, with 22%-42% of them experiencing 
aspiration[9]. In patients with aspiration, the risk of pneumonia increases, significantly raising their 
mortality[13]. Furthermore, dysphagia can exacerbate patients' mental health, particularly those 
unable to consume food via mouth, leading to symptoms such as malnutrition, depression, and 
social withdrawal[14]. 
At present, effective measures for treating pharyngeal dysphagia in stroke patients are still 
lacking. Under most circumstances, swallowing function training is the mainstream therapy 
provided to facilitate the improvement of dysphagia[15]. Fortunately, in our clinical practice, it was 
observed that stellate ganglion block (SGB) combined with swallowing function training can 
notably improve the swallowing function of stroke patients with pharyngeal phase dysphagia. 
Nonetheless, relevant study remains, still, insufficient.  
2.Objective     
The current study, therefore, was carried out to explore the clinical effect of SGB combined with 
comprehensive rehabilitation in post-stroke pharyngeal dysphagic patients, mainly on wallowing 
function and aspiration. 
3.Design 
3.Type：This was a multicenter randomized controlled study 
3.2 Study patient population 
From June 2022 to June 2023, we conducted a randomized controlled clinical study 
including 65 post-stroke patients with pharyngeal dysphagia who were transferred or admitted to 
the department of rehabilitation medicine of 3 hospitals in China. The inclusion criteria were: 1) 
Age between 30 and 80 years; 2) New-onset stroke, confirmed by head CT or MRI; 3) The course 
of disease between 1 to 6 months; 4) With pharyngeal dysphagia shown by VFSS; 5) Stable vital 
signs; 6) Voluntary participation in the study. The exclusion criteria were: 1) Allergy to Lidocaine 
injection or vitamin B12 injection; 2) Severe cognitive impairment; 3) Coagulation disorders; 4) 
Severe dysfunction of organs including heart, lungs, kidney, liver, etc.; 6) Complicated with other 
neurological diseases; 7) With severe oral dysphagia (results of the VFSS oral phase as 2 or 3 
points); 8) Dysphagia caused by other diseases or reasons. The shedding criteria were: 1) 
Infection at the site of blockade; 2) Patient’s own request; 3) the patient's condition deteriorated 
severely; 4) death. 
3.3Intervention 
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. 
 
Based on these, 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 

                
 
6 
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. The operator, with the tips of the index finger and middle finger, pushed the trachea and 
esophagus to the medial side, and the sternocleidomastoid muscle and common carotid artery to 
the lateral side. Next, the operator inserted the needle vertically until the needle tip reached the C7 
transverse process and then withdrew the needle slightly. If there was no blood or cerebrospinal 
fluid back drawn, the blocking drug should be slowly injected, and the presence of Horner's 
syndrome indicated a successful block. After the injection, the patient was required to keep lying 
down for 30 minutes to ensure there were no abnormal symptoms. 
4、Case selection 
4.1 The inclusion and exclusion criteria 
The inclusion criteria were: 1) Age between 30 and 80 years; 2) New-onset stroke, confirmed 
by head CT or MRI; 3) The course of disease between 1 to 6 months; 4) With pharyngeal 
dysphagia shown by VFSS; 5) Stable vital signs; 6) Voluntary participation in the study. The 
exclusion criteria were: 1) Allergy to Lidocaine injection or vitamin B12 injection; 2) Severe 
cognitive impairment; 3) Coagulation disorders; 4) Severe dysfunction of organs including heart, 
lungs, kidney, liver, etc.; 6) Complicated with other neurological diseases; 7) With severe oral 
dysphagia (results of the VFSS oral phase as 2 or 3 points); 8) Dysphagia caused by other diseases 
or reasons. 
4.2 The dropout criteria 
The shedding criteria were: 1) Infection at the site of blockade; 2) Patient’s own request; 3) 
the patient's condition deteriorated severely; 4) death. 
4.3 Termination criteria 
If more than half of the subjects experience mild or higher adverse reactions (such as 3/6, 
4/8), the trial should be terminated. 
5、Study management 
5.1 Ethical Considerations and Informed Consent 
5.1.1 Approval by an Independent Ethics Committee 
Prior to the commencement of the trial, the researcher/research institution should obtain 
written approval from the independent ethics committee regarding the trial protocol, informed 
consent form, subject recruitment procedures, and any other written materials to be provided to 
the subjects. During the course of the trial, if there are any additions or revisions to the trial 
protocol, informed consent form, etc., written approval from the independent ethics committee 
should be obtained again. 
5.1.2 Informed Consent 
The researcher or their designated representative will be responsible for explaining the 
background of the study, the pharmacological characteristics of the investigational medication, the 
trial protocol, as well as the potential benefits and risks of participating in the trial to each subject, 
the subject's legally authorized representative, or witness. They should obtain written informed 
consent signed by the subject or their legally authorized representative and the investigator before 
the subject enters the trial (before screening). 
The final text of the informed consent form should include the following: the purpose of the 
trial, trial procedures, the subject's obligations, the foreseeable benefits and risks and 
inconveniences of participating in the trial, treatment and appropriate insurance compensation 

                
 
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available to the subject in case of trial-related harm, access to trial data, and confidentiality of 
subject information. 
The informed consent form should obtain written approval from the ethics committee and be 
written in a language that is understandable to the subject. The subject or their legally authorized 
representative, the researcher conducting the informed consent process, or their representative 
should all sign and date the informed consent form. The original copy of the informed consent 
form should be retained by both the researcher and the subject. If important new information 
related to the investigational drug in a clinical trial is discovered, the informed consent form must 
be modified in writing, submitted for approval to the ethics committee, and re-obtained from the 
subject. 
5.2 Protection 
Prior to the start of the clinical trial, the trial protocol must be reviewed and approved by the 
ethics committee of the responsible research institution before implementation. Any modifications 
to the trial protocol during the course of the clinical trial should also be approved by the ethics 
committee before they can be executed. 
Clinical researchers must inform subjects that participation in the clinical trial is voluntary 
and that they have the right to withdraw from the trial at any stage without facing discrimination 
or retaliation. Subjects must be made aware that their participation in the trial and their personal 
information will be kept confidential. They should also be informed about the nature of the 
clinical trial, the trial objectives, the potential anticipated benefits, and the possible risks and 
inconveniences. Subjects should be informed of their rights and obligations as outlined in the 
Helsinki Declaration, and given sufficient time to consider whether they wish to participate in the 
trial. 
5.3 Management Unit 
This study will be conducted at the First Affiliated Hospital of Zhengzhou University and 
will be overseen by the ethics committee of the hospital and the clinical trial institution. 
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