Efficacy of Lidocaine Block in Children With Cerebral Palsy and Dysphagia

NCT06304090 | Not Yet Recruiting

• 1 other identifier: SGB-NT
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief Summary

The goal of this clinical trial is to test the efficacy of stellate ganglion block in children with cerebral palsy and dysphagia. The main question it aims to answer are: • Can stellate ganglion block improve the dysphagia of children with cerebral palsy? Participants were randomly divided into two groups, all provided with routine therapy. Based on this, the experimental group was given stellate ganglion block. The video fluoroscopic swallowing study was done to test the swallowing function before and after the study.

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

• Penetration-Aspiration Scale

  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.

  day 1 and day 10

Secondary Outcomes (1)

• Functional Oral Intake Scale

  day 1 and day 10

Study Arms (2)

routine rehabilitation treatment+Stellate ganglion block

EXPERIMENTAL

All participants were given routine rehabilitation treatment by professional rehabilitation therapists, including exercise therapy, guided education, psychological therapy, acupuncture and massage therapy, to promote the development of motor and cognitive function, as well as to improve intellectual development. Besides, swallowing function training was also provided, including direct training, indirect training, and compensatory training.The experimental group was given Stellate Ganglion Block.

Behavioral: routine rehabilitation treatment; Procedure: Stellate ganglion block; Drug: Lidocaine Hydrochloride

routine rehabilitation treatment+Placebo

PLACEBO COMPARATOR

All participants were given routine rehabilitation treatment by professional rehabilitation therapists, including exercise therapy, guided education, psychological therapy, acupuncture and massage therapy, to promote the development of motor and cognitive function, as well as to improve intellectual development. Besides, swallowing function training was also provided, including direct training, indirect training, and compensatory training.

Behavioral: routine rehabilitation treatment; Procedure: Stellate ganglion block

Interventions

routine rehabilitation treatment BEHAVIORAL

All participants were given routine rehabilitation treatment by professional rehabilitation therapists, including exercise therapy, guided education, psychological therapy, acupuncture and massage therapy, to promote the development of motor and cognitive function, as well as to improve intellectual development\[. Besides, swallowing function training was also provided, including direct training, indirect training, and compensatory training, as follows The mendelson maneuver: performed 5 days per week, twice per day, 5-10 minutes each time. Cold stimulation of the pharynx: performed every day, twice per day, 3-5 minutes each time. Passive head extension: to stretch the submental muscle for 2-3 seconds, with upward resistance applied to the lower cheek for no less than 5 times a day and no less than 5 minutes each time. Direct feeding training: with powdered milk, once a day, 5 days a week.

routine rehabilitation treatment+Placebo; routine rehabilitation treatment+Stellate ganglion block

Stellate ganglion block 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.

routine rehabilitation treatment+Placebo; routine rehabilitation treatment+Stellate ganglion block

Lidocaine Hydrochloride DRUG

The patients were provided with Stellate ganglion block , using 0.5ml 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.

Also known as: Lidocaine

routine rehabilitation treatment+Stellate ganglion block

Eligibility Criteria

• Age: 4 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• meeting the diagnostic criteria of cerebral palsy formulated by the 13th National Conference on Pediatric Cerebral Palsy Rehabilitation;
• age between 4 to 7 years;
• diagnosed as dysphagia confirmed by Dysphagia Disorder Survey or pediatric esophagoscopy;

You may not qualify if:

• with dysphagia caused by other diseases or factors;
• progressive neurological disease or degenerative neurological disease;
• with severe heart disease, liver or kidney dysfunction, hematological disorders;
• with abnormalities in the oral cavity, pharynx, esophagus, or other parts of the digestive tract;
• with poor compliance.

Sponsors & Collaborators

• Muhammad: lead

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Nieto Luis, Master

  Site Coordinator of United Medical Group

  STUDY CHAIR

Central Study Contacts

Lavie Ce, Master

CONTACT

15038177099; zenghongjixx@qq.com

Study Design

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

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 12, 2024
• Study Start: March 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share