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Not yet recruitingNCT06304090Updated Mar 15, 2024

Efficacy of Lidocaine Block in Children With Cerebral Palsy and Dysphagia

An interventional study of routine rehabilitation treatment and Stellate ganglion block in Cerebral Palsy, sponsored by Muhammad. Not yet recruiting. Open to participants aged 4 Years to 7 Years. Per ClinicalTrials.gov, last updated 2024-03-15.

Sponsored by Muhammad · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
4 Years to 7 Years
Sex
All
01

Study 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.
Read the detailed description

Cerebral palsy is a common non-progressive clinical condition characterized by motor disorders and abnormal postures, which significantly impact the quality of life of affected children. Swallowing dysfunction is a common complication in children with Cerebral palsy , affecting their daily eating and communication skills, and hindering their nutritional development and social interaction. Stellate ganglion block has shown certain efficacy in improving swallowing function in children with Cerebral palsy. However, there is limited research on the effects of stellate ganglion block treatment on swallowing dysfunction in children with Cerebral palsy. Therefore, this study aims to explore this topic and provide scientific evidence for its clinical application.

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.
02

Conditions studied

  • Cerebral Palsy

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03

Who can participate

Ages eligible
4 Years to 7 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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;

Exclusion criteria

Exclusion Criteria:

  • 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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    routine rehabilitation treatment+Stellate ganglion block

    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

  • Placebo comparator
    routine rehabilitation treatment+Placebo

    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

  • Behavioralroutine rehabilitation treatment

    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.

  • ProcedureStellate ganglion block

    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.

  • DrugLidocaine Hydrochloride

    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

05

What researchers measure

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.

    Time frame: day 1 and day 10

Secondary outcomes

  1. Functional Oral Intake Scale

    During Dysphagia-Functional Oral Intake Scale assessment, evaluators engage in communication with the patient, conduct observations, and make records to assess the patient's oral intake ability. The Functional Oral Intake Scale assessment form includes seven levels of scoring, ranging from level 1 to level 7, the increasing of scores indicating a progressive improvement in the patient's oral intake ability.

    Time frame: day 1 and day 10

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06304090
Lead sponsor
Muhammad
Responsible party
Muhammad (Research Director, Ahmadu Bello University Teaching Hospital) — Sponsor-investigator
First posted
Mar 12, 2024
Start date
Mar 2024 (estimated)
Primary completion
Dec 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
Mar 15, 2024

Study contacts

Lavie Ce, Master
Contact
zenghongjixx@qq.com
15038177099
Nieto Luis, Master
study chair · Site Coordinator of United Medical Group

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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