Efficacy of Stellate Ganglion Block in Traumatic Brain Injury Patients
- Conditions
- Traumatic Brain Injury
- Interventions
- Behavioral: Rehabilitation therapyProcedure: Stellate ganglion block
- Registration Number
- NCT06228170
- Lead Sponsor
- Zeng Changhao
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description The observation group Stellate ganglion block 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) The observation group Rehabilitation therapy 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) The control group Rehabilitation therapy 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.
- Primary Outcome Measures
Name Time Method Penetration-Aspiration Scale day 1 and day 20 On the day 1 and day 20, 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 Outcome Measures
Name Time Method Modified Barthel Index day 1 and day 20 On the day 1 and day 20, the activities of daily living of patients will be assessed using the modified Barthel Index . The scale includes 10 items such as feeding, bathing, walking, dressing. Each item is rated on a 4-point scale based on the level of assistance required, with a total score of 100 points. There is a positive correlation between activities of daily living and the final score.
Swallowing duration day 1 and day 20 The time duration that the patient swallowed the contrast agent under Videofluoroscopic Swallowing Study the is recorded.Unit: seconds.
Functional Oral Intake Scale day 1 and day 20 During Dysphagia-Functional Oral Intake Scale assessment, evaluators engage in communication with the patient, conduct observations, and make records to assess the patient's oral intake ability. The Functional Oral Intake Scale assessment form includes seven levels of scoring, ranging from level 1 to level 7, indicating a progressive improvement in the patient's oral intake ability.
Trial Locations
- Locations (1)
Zheng Da yi Yuan Hospital
🇨🇳Zhengzhou, Henan, China