Effect of Stellate Ganglion Block on Pharyngeal Dysphagia After Cerebralvascular Accident

Dysphagia Clinical Trial

Official title:

A Random Controlled Study to Explore the Effect of Stellate Ganglion Block on Pharyngeal Dysphagia After Cerebralvascular Accident

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06249464
• Other study ID #: SGB for stroke old
• Status: Completed
• Phase: N/A
• Start date: June 21, 2022
• Est. completion date: May 17, 2023

Study information

• Verified date: March 2024
• Source: People's Hospital of Zhengzhou University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This was a multicenter randomized controlled study. 66 post-stroke patients with pharyngeal dysphagia were randomly allocated to the observation group (n=33) or the control group (n=33). 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, Kubota water swallowing test, video fluoroscopic swallowing study (VFSS), and Rosenbek penetration-aspiration scale (PAS) were used to assess swallowing function.

Description:

Dysphagia is a frequent and potentially serious complication of stroke. However, there is no effective measure for the treatment of pharyngeal dysphagia in stroke patients. This study aims to explore the efficacy of stellate ganglion block in post-stroke pharyngeal dysphagic patients who received comprehensive rehabilitation. This was a multicenter randomized controlled study. 66 post-stroke patients with pharyngeal dysphagia were randomly allocated to the observation group (n=33) or the control group (n=33). 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, Kubota water swallowing test, video fluoroscopic swallowing study (VFSS), and Rosenbek penetration-aspiration scale (PAS) were used to assess swallowing function.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: May 17, 2023
• Est. primary completion date: May 2, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age between 30 and 80 years;
• New-onset stroke;
• The course of disease between 1 to 6 months;
• With pharyngeal dysphagia;
• Stable vital signs;
• Voluntary participation in the study.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Deglutition Disorders
• Dysphagia

Intervention

Behavioral:
• comprehensive rehabilitation
All the participants were 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.) and pharmacological treatment (aspirin, statins, anticoagulants, etc.). Regrading swallowing function training, both groups were given swallowing function training, including 1) exercises of closure of the vocal folds, pharyngeal, and laryngeal muscles exercises, and respiratory muscle strength training, for 15 min each time and twice per day. 2) isotonic/isometric swallowing exercises, supraglottic swallowing exercises, and the Mendelsohn maneuver, for 20 min each time and twice per day. 3) effortful swallowing exercises, and cough reflex training, for 10 min each time and twice per day.

Drug:
• Lidocaine hydrochloride
the observation group was given SGB once a day, with 10 sessions as a course of treatment and each side of the body for one course. All the materials included: 1) 1.5ml of 2% Lidocaine hydrochloride injection (1ml: 0.5mg), Vitamin B12 Injection 500ug (1ml: 0.5g), the 5 ml disposable syringe and the sterile disposable dental injection needles. The specific operation procedure was as follows[16]: The operator stood at the patient's block side, and the patient was placed in the supine position, with the head leaning 45 degrees toward the contralateral side of the block side. After routine disinfection of the skin, a paratracheal approach was adopted, which was, 2.5cm above the sternoclavicular joint and 1.5cm outside the midline of the neck.

Locations

Country	Name	City	State
Taiwan	Xinzhu Rehabilitation Hospital	Xinzhu

Sponsors (1)

Lead Sponsor	Collaborator
Zeng Changhao

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Video fluoroscopic swallowing study	The patient was required to take a sitting position with the head naturally upright. Under the guidance of the examiner, the patient first swallowed 5ml of iohexol solution (50ml:17.5g in iodine terms). If the patient exhibited aspiration, the test would stop. If not, the patient was instructed to swallow 10ml of iohexol solution mixed with breadcrumbs, and the patient's swallowing condition was observed with immediate measures ready to take for safety. Specially, the esophageal phase was not included in the study, because it was commonly regarded as an independent phase. The swallowing were divided into 3 phases in this assessment: Oral phase, Pharyngeal phase, and Aspiration, with maximum 3,3,4 points were given to each phase. The total score was calculated as the final result. The final score was positively correlated with the swallowing function.	day 1 and day 20
Secondary	Kubota water swallowing test	During the test, patients were required to drink 30 ml of warm water. According to the situation, the swallowing function was rated from Level 1 (excellent) to Level 5 (poor). Specifically, Grade 1: The patient drank all the water at once without choking; Grade II: The patient drank all the water in two or more times without choking; Grade III: The patient drank all the water at once with choking; Grade IV: The patient drank all the water in two or more times with choking; Grade V: The patient exhibited difficulty drinking with frequent choking.	day 1 and day 20
Secondary	penetration-aspiration scale	this assessment evaluated the patient's swallowing of contrast medium and whether there was retention, penetration, and aspiration. It included multiple items, each with the corresponding criteria, Specifically, whether the swallowed material entered the airway, passed through or contacted the vocal cords, and whether the patient exhibited the corresponding ability to clear. There were 8 levels in the results, with higher levels indicating more severe aspiration.	day 1 and day 20