Effect of Ultrasound-guided Stellate Ganglion Block Combined With Facial Nerve and Glossopharyngeal Nerve Block on the Treatment of Sudden Deafness

NCT05623384 | Unknown

• 1 other identifier: 20221031
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Sudden deafness is a sudden, unexplained sensorineural hearing loss of ≥20 dBHL in at least two adjacent frequencies within 72 h. It may be accompanied by tinnitus, a sense of ear congestion, vertigo and other Symptoms.Stellate ganglion block increases the blood flow and blood velocity in the inner ear, keeping the body's vegetative, endocrine and immune functions normal.The branches of the facial and linguopharyngeal nerves are connected to the inner ear, and local injection can nourish the nerves and improve local circulation.

Conditions

Sudden Deafness

Keywords

Sudden deafness; Stellate Ganglion Block; Facial nerve block; Glossopharyngeal nerve block

Outcome Measures

Primary Outcomes (1)

• Mean Hearing Threshold (PTA)

  The average of hearing thresholds at six frequencies (250, 500, 1000, 2000, 4000, and 8000 Hz) was recorded as the mean hearing threshold (PTA).

  Baseline (Before treatment)，1 month and 2 months after treatment

Study Arms (3)

Stellate ganglion block combined with facial and glossopharyngeal nerve block group

EXPERIMENTAL

Procedure: Stellate ganglion block; Procedure: Facial and glossopharyngeal nerve blocks; Drug: Mecobalamin Tablets

Stellate ganglion block group

EXPERIMENTAL

Procedure: Stellate ganglion block; Drug: Mecobalamin Tablets

Control group

OTHER

Drug: Mecobalamin Tablets

Interventions

Stellate ganglion block PROCEDURE

A cross-sectional scan with a high-frequency line array probe reveals the pre-C6 transverse nodule or C7 transverse process, and the structures of the thyroid, carotid sheath, vertebral artery, inferior thyroid artery, trachea, and esophagus are identified by observation. The carotid sheath is pushed out as far as possible laterally, the needle is inserted in the paratracheal sulcus, and the tip of the needle is passed through the lateral border of the thyroid into the deep anterior fascial surface of the long cervical muscle.After backdrawing no blood, cerebrospinal fluid or gas, 5 ml of lidocaine was injected.（lidocaine 80mg；Physiological saline 1ml）

Stellate ganglion block combined with facial and glossopharyngeal nerve block group; Stellate ganglion block group

Facial and glossopharyngeal nerve blocks PROCEDURE

The operator touches the position of the mastoid process and needles vertically at the front of the mastoid process directly below the external auditory canal. When the surface of the mastoid is touched, the needle is adjusted to pass through the front of the mastoid and then slowly needled for about 1 cm, and when the patient develops swelling and pain, 3 ml of the drug is injected. then the needle is slowly needled backward for about 1 cm, and when the patient develops swelling and pain, 2 ml of the drug is injected. （mecobalamin injection 1mg；lidocaine 20mg； dexamethasone 10mg ；Physiological saline 2ml）

Stellate ganglion block combined with facial and glossopharyngeal nerve block group

Mecobalamin Tablets DRUG

oral Mecobalamin Tablets tid-8

Control group; Stellate ganglion block combined with facial and glossopharyngeal nerve block group; Stellate ganglion block group

Eligibility Criteria

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

You may qualify if:

• Meet the diagnostic criteria for sudden deafness established by the Editorial Board of the Chinese Journal of Otolaryngology, Head and Neck Surgery and the Chinese Society of Otolaryngology, Head and Neck Surgery
• Age 18 to 80 years
• ASA classification Ⅰ\~Ⅲ grade

You may not qualify if:

• Acoustic conductance test, vestibular function test, cranial MRI, etc. suggest organic disease
• People with coagulation disorders or on anticoagulation therapy
• Infection at the puncture site
• Severe systemic diseases that cannot cooperate with treatment

Sponsors & Collaborators

• Zhuan Zhang: lead

Study Sites (1)

the Affiliated Hospital of Yangzhou University

Yangzhou, Jiangsu, China

RECRUITING

MeSH Terms

Conditions

Hearing Loss, Sudden

Interventions

mecobalamin

Condition Hierarchy (Ancestors)

Hearing Loss; Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• zhuan zhang, professor

  The Affiliated Hospital of Yangzhou University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

zhuan zhang, professor

CONTACT

+8615062791355; zhangzhuancg@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 13, 2022
• First Posted: November 21, 2022
• Study Start: November 14, 2022
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: November 21, 2022

Record last verified: 2022-11

Locations

CN (1)