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

Sudden Deafness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05623384
• Other study ID #: 20221031
• Status: Recruiting
• Phase: N/A
• Start date: November 14, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: November 2022
• Source: Yangzhou University
• Contact: zhuan zhang, professor
• Phone: +8615062791355
• Email: zhangzhuancg[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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 ?~? grade

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Deafness
• Ganglion Cysts
• Hearing Loss
• Hearing Loss, Sudden
• Sudden Deafness

Intervention

Procedure:
• Stellate ganglion block
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)
• Facial and glossopharyngeal nerve blocks
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)

Drug:
• Mecobalamin Tablets
oral Mecobalamin Tablets tid-8

Locations

Country	Name	City	State
China	the Affiliated Hospital of Yangzhou University	Yangzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Zhuan Zhang

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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