Efficacy of Stellate Ganglion Block in Traumatic Brain Injury Patients (SGB-TBI)

Zeng Changhao

Status: Withdrawn

Conditions: Traumatic Brain Injury

Treatments: Behavioral: Rehabilitation therapy; Procedure: Stellate ganglion block

Study type: Interventional

Funder types: Other

Identifiers

NCT06228170

2024-KY-0119-002

Details and patient eligibility

About

The goal of this or clinical trial is to explore efficacy of stellate ganglion block on dysphagia and activities of daily living in Traumatic Brain Injury Patients. The main question it aims to answer are:

Can stellate ganglion block improve the dysphagia and activities of daily living in Traumatic Brain Injury Patients.

Traumatic Brain Injury Patients will be divided into the the control 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, and activities of daily living of the two groups of patients before and after treatment were evaluated.

Full description

Dysphagia, or swallowing difficulty, is a common symptom in Traumatic Brain Injury Patients. The goal of this or clinical trial is to explore efficacy of stellate ganglion block on dysphagia and activities of daily living in Traumatic Brain Injury Patients. The main question it aims to answer are:

Can stellate ganglion block improve the dysphagia and activities of daily living in Traumatic Brain Injury Patients.

Traumatic Brain Injury Patients will be divided into the the control 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, and activities of daily living of the two groups of patients before and after treatment were evaluated.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age ≥ 18 years, meeting the diagnosis of Traumatic Brain Injury;
• presence of no contraindication for Stellate Ganglion Block;
• with stable vital signs and no severe liver or kidney dysfunction, metabolic disorders, cardiovascular diseases, or multiple complications;
• informed consent form was obtained from the patient's family members, indicating their full understanding of the study and agreement to participate.

Exclusion criteria

• unable to cooperate in completing treatment and assessment due to personal reasons or other disorders;
• complicated with other intracranial lesions, such as stroke;
• with severe consciousness disorders caused by other diseases.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups

The observation group

Experimental group

Description:

The study lasted 20d 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 with stellate ganglion block, using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g)

Treatment:

Procedure: Stellate ganglion block

Behavioral: Rehabilitation therapy

The control group

Active Comparator group

Description:

The study lasted 20d 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.

Treatment:

Behavioral: Rehabilitation therapy