A Randomized Controlled Study to Explore Clinical Effect of Lidocaine Block on Gastroesophageal Reflux Disease
Overview
- Phase
- Not Applicable
- Intervention
- Rehabilitation therapy
- Conditions
- Gastroesophageal Reflux Disease
- Sponsor
- Muhammad
- Enrollment
- 80
- Primary Endpoint
- Gastroesophageal Reflux Disease Questionnaire
- Status
- Not yet recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
The goal of this clinical trial is to explore Clinical Effect of Stellate Ganglion Block on Gastroesophageal Reflux Disease. The main question it aims to answer is:
• Can stellate ganglion block improve gastroesophageal reflux symptoms better on the basis of rehabilitation training? Participants will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Stellate Ganglion Block once a day additionally. The study lasts 10 days for each participant. Researchers will compare the Gastroesophageal Reflux Disease Questionnaire, Pressure pain threshold, Self-Evaluation Questionnaire for Gastroesophageal Reflux Disease, to see if the Stellate Ganglion Block can help improve the symptom.
Detailed Description
Gastroesophageal reflux is a common digestive disorder characterized by the backflow of stomach contents and fluids into the esophagus. The goal of this clinical trial is to explore Clinical Effect of Stellate Ganglion Block on Gastroesophageal Reflux Disease. The main question it aims to answer is: • Can stellate ganglion block improve gastroesophageal reflux symptoms better on the basis of rehabilitation training? Participants will be randomly allocated into the control group or the experimental group, all under rehabilitation treatment, the experimental group will be given Stellate Ganglion Block once a day additionally. The study lasts 10 days for each participant. Researchers will compare the Gastroesophageal Reflux Disease Questionnaire, Pressure pain threshold, Self-Evaluation Questionnaire for Gastroesophageal Reflux Disease, to see if the Stellate Ganglion Block can help improve the symptom.
Investigators
Muhammad
Research Director
Ahmadu Bello University Teaching Hospital
Eligibility Criteria
Inclusion Criteria
- •Gastroesophageal Reflux Disease diagnosis
- •aged between 18 and 80 years old.
- •subjects who tolerate cervical movements in sitting position.
- •stable vital signs.
- •normal consciousness
Exclusion Criteria
- •contraindications for stellate ganglion block.
- •peptic ulcer.
- •previous or present gastric cancer.
- •previous gastric surgery.
- •recent fractures or cervical trauma.
Arms & Interventions
Rehabilitation therapy+Stellate ganglion block
The study lasts 10 days for each patient. During the treatment, All the participants are provided with the rehabilitation therapy. Based on this, the patients in the experimental group are provided with Stellate Ganglion Block , using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g), once a day.
Intervention: Rehabilitation therapy
Rehabilitation therapy+Stellate ganglion block
The study lasts 10 days for each patient. During the treatment, All the participants are provided with the rehabilitation therapy. Based on this, the patients in the experimental group are provided with Stellate Ganglion Block , using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g), once a day.
Intervention: Injection
Rehabilitation therapy+Stellate ganglion block
The study lasts 10 days for each patient. During the treatment, All the participants are provided with the rehabilitation therapy. Based on this, the patients in the experimental group are provided with Stellate Ganglion Block , using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g), once a day.
Intervention: Lidocaine hydrochloride
Rehabilitation therapy+placebo block
The study lasts 20d for each patient. During the treatment, All the participants are provided with the rehabilitation therapy. This group will be additionally provided with placebo block without any drugs.
Intervention: Rehabilitation therapy
Rehabilitation therapy+placebo block
The study lasts 20d for each patient. During the treatment, All the participants are provided with the rehabilitation therapy. This group will be additionally provided with placebo block without any drugs.
Intervention: Injection
Outcomes
Primary Outcomes
Gastroesophageal Reflux Disease Questionnaire
Time Frame: day 1 and day 10
The Gastroesophageal Reflux Disease Questionnaire is a commonly used questionnaire for assessing the symptoms and severity of gastroesophageal reflux disease. It was developed by gastrointestinal experts in Germany and consists of six questions that evaluate the frequency and severity of gastroesophageal reflux disease symptoms. For each question, patients are required to select the answer that best corresponds to their situation. Different scores are assigned based on the chosen answers, and a total score is calculated at the end.
Secondary Outcomes
- Pressure pain threshold(day 1 and day 10)
- Modified Mayo Clinic Dysphagia-30 questionnaire(day 1 and day 10)