Exploration of Stellate Ganglion Block in Patients With Cerebral Small Vessel Disease

NCT06226415 | Completed DMC

• 1 other identifier: 2024-KY-0118
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 3

Brief Summary

This is a prospective study conducted on patients with Cerebral Small Vessel Disease, dysphagia and cognitive impairment. They were divided into the comparison group and observation group evenly. All the patients were provided with routine therapy, while the patients in the observation group were given Stellate Ganglion Block. The swallowing function, cognitive function and activities of daily living of the two groups of patients before and after treatment were evaluated by Penetration-Aspiration Scale, Mini-mental state examination and modified Barthel index.

Conditions

Cerebral Small Vessel Diseases

Outcome Measures

Primary Outcomes (1)

• Penetration-Aspiration Scale

  On the day 1 and day 14, 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 and day 14

Secondary Outcomes (4)

• Modified Barthel Index

  day 1 and day 14

• Mini-Mental State Examination

  day 1 and day 14

• Modified Barium Swallow Impairment Profile

  day 1 and day 14

• Functional Oral Intake Scale

  day 1 and day 14

Study Arms (2)

The comparison group

ACTIVE COMPARATOR

The study lasted 14d for each patient. During the treatment, All the participants were provided with the rehabilitation therapy, which included routine rehabilitation, cognitive training, swallowing function training and nutrition support.

Behavioral: Rehabilitation therapy

The observation group

EXPERIMENTAL

The study lasted 14d for each patient. During the treatment, All the participants were provided with the rehabilitation therapy, which included routine rehabilitation, cognitive training, swallowing function training and nutrition support. Based on the invention above, the patients in the observation group were provided, using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g).

Behavioral: Rehabilitation therapy; Procedure: Stellate ganglion block; Drug: Lidocaine Hydrochloride

Interventions

Rehabilitation therapy BEHAVIORAL

The study lasted 14d for each patient. During the treatment, All the participants were provided with the rehabilitation therapy, which included routine rehabilitation, cognitive training, swallowing function training and nutrition support. Particularly, due to dysphagia, the patients enrolled might face difficulty in eating. For patients who were able to finish intake via mouth by compensatory means, the consistency, type, and size of food bolus was arranged. For those who cannot acquire sufficient nutrition through oral intake, the nasogastric tube feeding was provided.

The comparison group; The observation group

Stellate ganglion block PROCEDURE

Based on the invention above, the patients in the observation group were provided with Stellate ganglion block, using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g). 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 observation group

Lidocaine Hydrochloride DRUG

Based on the invention above, the patients in the observation group were provided with Stellate ganglion block, using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g). 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.

Also known as: Lidocaine

The observation group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age\>18 years.
• Meeting the diagnostic criteria for cerebral small vessel disease.
• Dysphagia confirmed by Videofluoroscopic Swallowing Study
• Mini-Mental State Examination (MMSE)\<27, indicating the existence of cognitive impairment.
• No history of prior stroke.
• Stable vital signs.

You may not qualify if:

• Dysphagia that might be caused by other diseases that might cause dysphagia, such as head and neck tumors, traumatic brain injury, myasthenia gravis, etc.
• Cognitive impairment that might be caused by other diseases, such as Alzheimer's disease, Parkinson's disease, brain injury, etc.
• Neurological blockade contraindications such as bleeding tendency, blocked site infection.
• Unable to successfully finish the assessment of this study.
• Complicated with severe liver and kidney failure, tumors, or hematological disorders.
• Simultaneously in need to undergo other therapy that might affect the outcomes of this study.
• Pregnant or nursing females

Sponsors & Collaborators

• Zeng Changhao: lead

Study Sites (3)

Affiated Hos. Campus of zdy

Zhongguo, China

Location

River south medical affili. Campus of zdy

Zhongguo, China

Location

The 4th affili. (Huij) Campus of zdy

Zhongguo, China

Location

MeSH Terms

Conditions

Cerebral Small Vessel Diseases

Interventions

Rehabilitation; Lidocaine

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Nieto Luis, Master

  Site Coordinator of United Medical Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: January 18, 2024
• First Posted: January 26, 2024
• Study Start: January 20, 2024
• Primary Completion: May 25, 2024
• Study Completion: June 1, 2024
• Last Updated: June 12, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)