Stellate Ganglion Block on Gastroesophageal Reflux Disease

Copka Sonpashan

Status: Not yet enrolling

Conditions: Gastroesophageal Reflux Disease

Treatments: Drug: Lidocaine hydrochloride; Procedure: Placebo injection; Behavioral: Rehabilitation therapy; Procedure: Stellate ganglion block

Study type: Interventional

Funder types: Other

Identifiers

NCT06319521

SGB-REFLUX

Details and patient eligibility

About

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.

Full 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 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Rehabilitation therapy+Stellate ganglion block

Experimental group

Description:

The study lasts 10d 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.

Treatment:

Drug: Lidocaine hydrochloride

Behavioral: Rehabilitation therapy

Procedure: Stellate ganglion block

Rehabilitation therapy+placebo block

Placebo Comparator group

Description:

The study lasts 10d for each patient. During the treatment, All the participants are provided with the rehabilitation therapy.

Treatment:

Procedure: Placebo injection

Behavioral: Rehabilitation therapy