Clinical Effect of Stellate Ganglion Block on Gastroesophageal Reflux Disease

NCT06215742 | Withdrawn DMC

• 1 other identifier: 2024-KY-0110
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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 20 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.

Conditions

Gastroesophageal Reflux Disease

Outcome Measures

Primary Outcomes (1)

• Gastroesophageal Reflux Disease Questionnaire

  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. The maximum score for the Test is 12 points, with a lower score indicating milder symptoms and a higher score indicating more severe symptoms.

  day 1 and day 20

Secondary Outcomes (2)

• Pressure pain threshold

  day 1 and day 20

• Modified Mayo Clinic Dysphagia-30 questionnaire

  day 1 and day 20

Study Arms (2)

the experimental group

EXPERIMENTAL

The study lasts 20d 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.

Behavioral: Rehabilitation therapy; Procedure: Stellate ganglion block

the control group

ACTIVE COMPARATOR

The study lasts 20d for each patient. During the treatment, All the participants are provided with the rehabilitation therapy.

Behavioral: Rehabilitation therapy

Interventions

Rehabilitation therapy BEHAVIORAL

Rehabilitation therapy includes 1. Diet management: Avoiding consumption of irritant foods and beverages, such as spicy foods, caffeine, alcohol, and acidic foods. Controlling portion sizes and meal timing, and adopting smaller, more frequent meals. 2. Lifestyle adjustments: Avoiding lying down or bending immediately after meals, maintaining a sitting or upright position for at least 2 hours. Adjusting sleeping positions by elevating the head of the bed to reduce nighttime acid reflux. Avoiding excessive exertion and managing stress levels. 3. Rehabilitation training: Strengthening the control of esophageal and gastric muscles through rehabilitation exercises to improve the function of the gastroesophageal sphincter and prevent gastric fluid reflux.

the control group; the experimental group

Stellate ganglion block PROCEDURE

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 percutaneous approach via the paratracheal route was used for Stellate ganglion block. The operator stood on the side of the block, instructed the patient to lie supine with a thin pillow placed below the shoulders, and tilted the head 45° towards the blocked side, fully exposing the neck. Then, routine disinfection of the neck skin was performed. The puncture site was located 2.5 cm above the sternoclavicular joint and 1.5 cm lateral to the midline of the neck.

the experimental group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Gastroesophageal Reflux Disease diagnosis after determination of acid reflux by gastroenterologist, with upper endoscopy and/or impedance-pHmetry, which confirmed esophagitis and/or hiatal hernia.
• aged between 18 and 80 years old.
• subjects who tolerate cervical movements in sitting position.
• stable vital signs.
• normal consciousness

You may not qualify if:

• contraindications for stellate ganglion block.
• peptic ulcer.
• previous or present gastric cancer.
• previous gastric surgery.
• recent fractures or cervical trauma.

Sponsors & Collaborators

• Zeng Changhao: lead

Study Sites (1)

Zheng Da yi Yuan Hospital

Zhengzhou, Henan, 450000, China

Location

MeSH Terms

Conditions

Gastroesophageal Reflux

Interventions

Rehabilitation

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Nieto Luis, Master

  Site Coordinator of United Medical Group located in Miami

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Director

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: January 22, 2024
• Study Start: January 30, 2024
• Primary Completion: April 30, 2024
• Study Completion: May 15, 2024
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)