Effectiveness of Lidocaine Injection on Stellate Ganglion in Pediatric Patients With Autism Spectrum Disorder

NCT ID: NCT06301685

Last Updated: 2024-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-31

Study Completion Date

2024-06-30

Brief Summary

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The goal of this clinical trial is to explore efficacy of stellate ganglion block Children with Autistic Disorder. The main question it aims to answer is:

Can stellate ganglion block improve the Autistic Disorder in children? Children with Autistic Disorder will be divided into the control group and experimental group evenly. All the patients were provided with routine therapy, while the patients in the experimental group were given stellate ganglion block. The Childhood Autism Rating Scale of the two groups of patients before and after treatment are evaluated.

Detailed Description

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Autistic Disorder in children is becoming increasingly more. The goal of this clinical trial is to explore efficacy of stellate ganglion block Children with Autistic Disorder. The main question it aims to answer is:

Can stellate ganglion block improve the Autistic Disorder in children? Children with Autistic Disorder will be divided into the control group and experimental group evenly. All the patients were provided with routine therapy, while the patients in the experimental group were given stellate ganglion block. The Childhood Autism Rating Scale of the two groups of patients before and after treatment are evaluated.

Conditions

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Autistic Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Routine therapy+Stellate ganglion block

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

Based on the invention above, the patients were provided with stellate ganglion block, using 1.5ml of 2% Lidocaine hydrochloride (1ml: 0.5mg) and 500ug of Vitamin B12 (1ml: 0.5g)

Group Type EXPERIMENTAL

Routine therapy

Intervention Type BEHAVIORAL

The study lasts 10 days for each patient. During the treatment, All the participants are provided with the routine therapy, which included routine rehabilitation, cognitive training.

Injection

Intervention Type PROCEDURE

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.

Lidocaine Hydrochloride

Intervention Type DRUG

the patients 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. once a day.

Routine therapy+Placebo

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

Group Type PLACEBO_COMPARATOR

Routine therapy

Intervention Type BEHAVIORAL

The study lasts 10 days for each patient. During the treatment, All the participants are provided with the routine therapy, which included routine rehabilitation, cognitive training.

Injection

Intervention Type PROCEDURE

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.

Interventions

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Routine therapy

The study lasts 10 days for each patient. During the treatment, All the participants are provided with the routine therapy, which included routine rehabilitation, cognitive training.

Intervention Type BEHAVIORAL

Injection

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.

Intervention Type PROCEDURE

Lidocaine Hydrochloride

the patients 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. once a day.

Intervention Type DRUG

Other Intervention Names

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Lidocaine

Eligibility Criteria

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Inclusion Criteria

* Diagnosed as Autistic Disorder.
* Aged between 3 years old and 6 years old.
* No contraindications to stellate ganglion block.

Exclusion Criteria

* Other significant physical or neurodevelopmental disorders.
* Other significant medical conditions
Minimum Eligible Age

3 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Muhammad

OTHER

Sponsor Role lead

Responsible Party

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Muhammad

Research Director

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Nieto Luis, Master

Role: STUDY_DIRECTOR

Site Coordinator of United Medical Group

Central Contacts

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Lavie Ce, Master

Role: CONTACT

15333828388

Other Identifiers

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SGB-AST

Identifier Type: -

Identifier Source: org_study_id

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