A Randomized Controlled Study to Explore the Efficacy of Stellate Ganglion Block in Traumatic Brain Injury Patients
Overview
- Phase
- Not Applicable
- Intervention
- Rehabilitation therapy
- Conditions
- Traumatic Brain Injury
- Sponsor
- Copka Sonpashan
- Enrollment
- 100
- Primary Endpoint
- Penetration-Aspiration Scale
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed 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.
Investigators
Copka Sonpashan
Research Director
Chao Phya Abhaibhubejhr Hospital
Eligibility Criteria
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.
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.
Arms & Interventions
Rehabilitation therapy+Stellate ganglion block
The study lasted 10d 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)
Intervention: Rehabilitation therapy
Rehabilitation therapy+placebo block
The study lasted 10d 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.
Intervention: Placebo block
Rehabilitation therapy+Stellate ganglion block
The study lasted 10d 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)
Intervention: Stellate ganglion block
Rehabilitation therapy+Stellate ganglion block
The study lasted 10d 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)
Intervention: Lidocaine Hydrochloride
Rehabilitation therapy+placebo block
The study lasted 10d 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.
Intervention: Rehabilitation therapy
Outcomes
Primary Outcomes
Penetration-Aspiration Scale
Time Frame: day 1 and day 10
Penetration-Aspiration Scale is used to assess dysphagia under Videofluoroscopic Swallowing Study, primarily evaluating the extent to which fluid food enter the airway and caused penetration or aspiration during the swallowing process. As the level increases, the severity of dysphagia also increases.
Secondary Outcomes
- Modified Barthel Index(day 1 and day 10)
- Swallowing duration(day 1 and day 10)
- Functional Oral Intake Scale(day 1 and day 10)