Stellate Ganglion Block in Bulbar Palsy

May 5, 2026 updated by: Zeng Xi

A Randomized Controlled Study to Explore the Effect of Stellate Ganglion Block in Dysphagic Patients With Bulbar Palsy After Ischemic Stroke

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
124

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Guandong, China
        • zhongshan affiliated No.1 Hospital
      • Heilongjiang, China
        • HLJ older people hospital
      • Henan, China
        • Lankao Renmen Hospital
      • Naning, China
        • NY zhongxin Hospital
      • Suzhu, China
        • People's Hospital of SN tequ
      • Zhenzhou, China
        • Department of rehabilitation medicine, the first ZU hospital north campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Comprehensive rehabilitation+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.
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.
Placebo Comparator: Comprehensive rehabilitation+placebo
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.
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.).
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Modified Barium Swallow Impairment Profile
Time Frame: 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.
day 1 before any intervention, day 11, and day 60

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Murray secretion severity scale
Time Frame: 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.
day 1 before any intervention, day 11, and day 60
Yale pharyngeal residue severity rating scale
Time Frame: 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.
day 1 before any intervention, day 11, and day 60
Penetration-Aspiration Scale
Time Frame: 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.
day 1 before any intervention, day 11, and day 60
Generalized Anxiety Disorder 7-item scale
Time Frame: 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.
day 1 before any intervention, day 11, and day 60
Movement distances of the hyoid bone
Time Frame: 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.
day 1 before any intervention, day 11, and day 60
Vertebral artery cerebral blood flow velocity
Time Frame: 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.
day 1 before any intervention, day 11, and day 60
Vertebral artery internal diameter
Time Frame: 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°.
day 1 before any intervention, day 11, and day 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Zeng Xi

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Nieto Luis, Site Coordinator of United Medical Group

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 23, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 5, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 5, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 10, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 19, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 20, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 5, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SGB-ZHENQIU

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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