Stellate Ganglion Block: A Breakthrough Treatment for Post-Stroke Pharyngeal Dysphagia

NCT06189560 | Terminated DMC

• 1 other identifier: 2022-KY-0049-002
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dysphagia; Stellate Ganglion Block

Keywords

Stellate ganglion block; Pharyngeal Dysphagia; Stroke; Rehabilitation; Swallowing disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Kubota water swallowing test

  day 1 and day 20

• Rosenbek penetration-aspiration scale

  day 1 and day 20

Study Arms (2)

The observation group

EXPERIMENTAL

Patients enrolled were firstly numbered for privacy with software and divided into the observation group (n=33) and the control group (n=33) with a random number table. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasted 20 days.

Behavioral: comprehensive rehabilitation; Drug: SGB

The control group

ACTIVE COMPARATOR

Patients enrolled were firstly numbered for privacy with software and divided into the observation group (n=33) and the control group (n=33) with a random number table. Additionally, the staffs involved in assessment would not participate in the intervention of the study. The treatment lasted 20 days.

Behavioral: comprehensive rehabilitation

Interventions

comprehensive rehabilitation BEHAVIORAL

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.

The control group; The observation group

SGB DRUG

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.

The observation group

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 30 and 80 years;
• New-onset stroke, confirmed by head CT or MRI;
• The course of disease between 1 to 6 months;
• With pharyngeal dysphagia shown by VFSS;
• Stable vital signs;
• Voluntary participation in the study.

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;
• With severe oral dysphagia (results of the VFSS oral phase as 2 or 3 points);
• Dysphagia caused by other diseases or reasons.

Sponsors & Collaborators

• Zeng Changhao: lead

Study Sites (1)

Zheng da yi fu yuan hospital

Zhengzhou, Henan, 450000, China

Location

Related Publications (8)

• GBD 2019 Stroke Collaborators. Global, regional, and national burden of stroke and its risk factors, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Neurol. 2021 Oct;20(10):795-820. doi: 10.1016/S1474-4422(21)00252-0. Epub 2021 Sep 3.

  PMID: 34487721 BACKGROUND

• Gilman RH, Marquis GS, Miranda E, Vestegui M, Martinez H. Rapid reinfection by Giardia lamblia after treatment in a hyperendemic Third World community. Lancet. 1988 Feb 13;1(8581):343-5. doi: 10.1016/s0140-6736(88)91131-2.

  PMID: 2893149 BACKGROUND

• Bejot Y, Bailly H, Graber M, Garnier L, Laville A, Dubourget L, Mielle N, Chevalier C, Durier J, Giroud M. Impact of the Ageing Population on the Burden of Stroke: The Dijon Stroke Registry. Neuroepidemiology. 2019;52(1-2):78-85. doi: 10.1159/000492820. Epub 2019 Jan 2.

  PMID: 30602168 BACKGROUND

• Jones CA, Colletti CM, Ding MC. Post-stroke Dysphagia: Recent Insights and Unanswered Questions. Curr Neurol Neurosci Rep. 2020 Nov 2;20(12):61. doi: 10.1007/s11910-020-01081-z.

  PMID: 33136216 BACKGROUND

• Zhang G, Li Z, Gu H, Zhang R, Meng X, Li H, Wang Y, Zhao X, Wang Y, Liu G; Chinese Stroke Center Alliance investigators. Dysphagia Management and Outcomes in Elderly Stroke Patients with Malnutrition Risk: Results from Chinese Stroke Center Alliance. Clin Interv Aging. 2022 Mar 17;17:295-308. doi: 10.2147/CIA.S346824. eCollection 2022.

  PMID: 35321149 BACKGROUND

• Doi S, Cho N, Obara T. Stellate ganglion block increases blood flow in the anastomotic artery after superficial temporal artery-middle cerebral artery bypass. Br J Anaesth. 2016 Sep;117(3):395-6. doi: 10.1093/bja/aew230. No abstract available.

  PMID: 27543535 RESULT

• ter Laan M, van Dijk JM, Elting JW, Staal MJ, Absalom AR. Sympathetic regulation of cerebral blood flow in humans: a review. Br J Anaesth. 2013 Sep;111(3):361-7. doi: 10.1093/bja/aet122. Epub 2013 Apr 24.

  PMID: 23616589 RESULT

• Li TT, Wan Q, Zhang X, Xiao Y, Sun LY, Zhang YR, Liu XN, Yang WC. Stellate ganglion block reduces inflammation and improves neurological function in diabetic rats during ischemic stroke. Neural Regen Res. 2022 Sep;17(9):1991-1997. doi: 10.4103/1673-5374.335162.

  PMID: 35142688 RESULT

MeSH Terms

Conditions

Deglutition Disorders; Stroke

Condition Hierarchy (Ancestors)

Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Nieto Luis, Master

  Site Coordinator of United Medical Group located in Miami

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PI

Study Record Dates

• First Submitted: November 29, 2023
• First Posted: January 3, 2024
• Study Start: June 21, 2022
• Primary Completion: May 2, 2023
• Study Completion: May 17, 2023
• Last Updated: March 5, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)