Effect of Lidocaine Block in Traumatic Brain Injury: A Double-blind Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 主要终点
- Penetration-Aspiration Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •informed consent form was obtained from the patient's family members, indicating their full - understanding of the study and agreement to participate.
排除标准
- •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.
研究组 & 干预措施
Rehabilitation therapy+Stellate ganglion block
The study lasted 10 days 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)
干预措施: Rehabilitation therapy (Behavioral)
Rehabilitation therapy+Stellate ganglion block
The study lasted 10 days 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)
干预措施: Stellate ganglion block (Procedure)
Rehabilitation therapy+Stellate ganglion block
The study lasted 10 days 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)
干预措施: Lidocaine Hydrochloride (Drug)
Rehabilitation therapy+Placebo
The study lasted 10 days 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.
干预措施: Rehabilitation therapy (Behavioral)
Rehabilitation therapy+Placebo
The study lasted 10 days 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.
干预措施: Stellate ganglion block (Procedure)
结局指标
主要结局
Penetration-Aspiration Scale
时间窗: 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. The score ranges 1 to 8.
次要结局
- Functional Oral Intake Scale(day 1 and day 10)
- Modified Barthel Index(day 1 and day 10)
- Swallowing duration(day 1 and day 10)
研究者
Muhammad
Research Director
Ahmadu Bello University Teaching Hospital