A Nerve Block Therapy for Bulbar Palsy Pharyngeal Dysphagia

NCT06347250 | Completed

• 1 other identifier: SGB-Bulbar Palsy
• Study Type: interventional
• Target: 122
• 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 or the control group. 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 Rosenbek penetration-aspiration scale (PAS) were used to assess swallowing function.

Conditions

Bulbar Palsy

Outcome Measures

Primary Outcomes (1)

• The 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 (4)

• Yale Pharyngeal Residue Severity Rating Scale

  day 1 and day 10

• penetration-aspiration scale

  day 1 and day 10

• Video fluoroscopic swallowing study

  day 1 and day 10

• The Swallowing Quality of Life Questionnaire

  day 1 and day 10

Study Arms (2)

Nerve block

EXPERIMENTAL

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

Procedure: Nerve Block; Drug: Lidocaine Hydrochloride; Behavioral: routine therapy

placebo

PLACEBO COMPARATOR

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

Behavioral: routine therapy; Procedure: placebo block

Interventions

Nerve 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.

Nerve block

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).

Nerve block

routine 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.). Regrading swallowing function training, both groups are 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, 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.

Nerve block; placebo

placebo block PROCEDURE

the patients were provided with normal saline. 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.

placebo

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.
• Upper Esophageal Sphincter did not open or opened ineffectively, with food residue or aspiration, revealed by Videofluoroscopic Swallow Study.
• 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

• Babujinaya Cela: lead

Study Sites (1)

ZhenD No.1 Hos.

Zhenzhou, China

Location

MeSH Terms

Conditions

Bulbar Palsy, Progressive

Interventions

Nerve Block; Lidocaine

Condition Hierarchy (Ancestors)

Motor Neuron Disease; Neurodegenerative Diseases; Nervous System Diseases; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Denervation; Neurosurgical Procedures; Surgical Procedures, Operative; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Nieto Luis, Master

  Site Coordinator of United Medical Group

  STUDY DIRECTOR

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: April 4, 2024
• Study Start: January 1, 2022
• Primary Completion: May 2, 2023
• Study Completion: May 31, 2023
• Last Updated: April 4, 2024

Record last verified: 2024-03

Locations

CN (1)