Effect of Stellate Nerve Block in Dysphagia

NCT06335316 | Completed

• 1 other identifier: wallenburg sym
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized controlled study, including dysphagic patients with bulbar palsy after ischemic stroke who were received in the department of rehabilitation medicine in China. Both groups were provided with comprehensive rehabilitation including routine rehabilitation and swallowing function training. Besides, the observation group additionally underwent the stellate ganglion block (SGB). At admission and after 20-day treatment,Yale Pharyngeal Residue Severity Rating Scale, video fluoroscopic swallowing study (VFSS), Functional Oral Intake Scale, and penetration-aspiration scale (PAS) were used to assess swallowing function.

Conditions

Dysphagia

Outcome Measures

Primary Outcomes (1)

• Functional Oral Intake Scale

  The Functional Oral Intake Scale (FOIS) is a tool used to assess the level of independence in oral intake for individuals with swallowing difficulties. The scale ranges from Level 1 to Level 7, with higher Levels indicating better swallowing function.

  day 1 and day 10

Secondary Outcomes (3)

• Yale Pharyngeal Residue Severity Rating Scale

  day 1 and day 10

• penetration-aspiration scale

  day 1 and day 10

• The Swallowing Quality of Life Questionnaire

  day 1 and day 10

Study Arms (2)

Stellate Nerve Block+ routine rehabilitation treatment

EXPERIMENTAL

The patients were given Nerve block and routine rehabilitation treatment for 10 days.

Procedure: Injection; Drug: Lidocaine Hydrochloride; Behavioral: Comprehensive therapy

placebo+routine rehabilitation treatment

PLACEBO COMPARATOR

The patients were given placebo block and routine rehabilitation treatment for 10 days.

Behavioral: Comprehensive therapy; Behavioral: placebo

Interventions

Injection 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.

Stellate Nerve Block+ routine rehabilitation treatment

Lidocaine Hydrochloride 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)

Stellate Nerve Block+ routine rehabilitation treatment

Comprehensive therapy BEHAVIORAL

All the participants are provided with the comprehensive rehabilitation (routine rehabilitation and swallowing function training). The routine rehabilitation included intervention for risk factors (blood pressure, blood lipids, blood glucose, smoking and alcohol restriction, exercise, etc.).

Stellate Nerve Block+ routine rehabilitation treatment; placebo+routine rehabilitation treatment

placebo BEHAVIORAL

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. Only normal saline was used

placebo+routine rehabilitation treatment

Eligibility Criteria

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

You may qualify if:

• Diagnosed with ischemic stroke according to the diagnostic criteria, with the stroke occurring in the medulla oblongata and diagnosed as bulbar palsy.
• Dysphagia.
• Age \>18 years.
• First-time stroke.
• Steady vital signs,
• Transferred or admitted to the Department of Rehabilitation Medicine within 15d after onset.

You may not qualify if:

• Allergy to Lidocaine injection or vitamin B12 injection;
• Severe cognitive impairment;
• Coagulation disorders;
• Severe dysfunction of organs including heart, lungs, kidney, liver, etc.;
• Complicated with other neurological diseases;
• Dysphagia caused by other diseases or reasons.

Sponsors & Collaborators

• Copka Sonpashan: lead

Study Sites (1)

Huimin Hos.

Pengfu, Taiwan

Location

MeSH Terms

Conditions

Deglutition Disorders

Interventions

Injections; Lidocaine

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Nieto Luis, Master

  Site Coordinator of United Medical Group

  STUDY CHAIR

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 GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: March 22, 2024
• First Posted: March 28, 2024
• Study Start: January 1, 2022
• Primary Completion: May 4, 2023
• Study Completion: May 28, 2023
• Last Updated: March 28, 2024

Record last verified: 2024-03

Locations

TW (1)