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

NCT ID: NCT05623384

Last Updated: 2022-11-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-14
• Study Completion Date: 2023-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Stellate ganglion block combined with facial and glossopharyngeal nerve block group

Group Type: EXPERIMENTAL

Stellate ganglion block

Intervention Type: 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）

Facial and glossopharyngeal nerve blocks

Intervention Type: 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）

Mecobalamin Tablets

Intervention Type: DRUG

oral Mecobalamin Tablets tid-8

Stellate ganglion block group

Group Type: EXPERIMENTAL

Stellate ganglion block

Intervention Type: 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）

Mecobalamin Tablets

Intervention Type: DRUG

oral Mecobalamin Tablets tid-8

Control group

Group Type: OTHER

Mecobalamin Tablets

Intervention Type: DRUG

oral Mecobalamin Tablets tid-8

Interventions

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）

Intervention Type: PROCEDURE

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）

Intervention Type: PROCEDURE

Mecobalamin Tablets

oral Mecobalamin Tablets tid-8

Intervention Type: DRUG

Eligibility Criteria

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 Ⅰ~Ⅲ 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhuan Zhang

OTHER

Sponsor Role: lead

Responsible Party

Zhuan Zhang

Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

zhuan zhang, professor

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Hospital of Yangzhou University

Locations

the Affiliated Hospital of Yangzhou University

Yangzhou, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

zhuan zhang, professor

Role: CONTACT

zhangzhuancg@163.com

+8615062791355

Facility Contacts

zhuan zhang, professor

Role: primary

zhangzhuancg@163.com

+8615062791355 ext. +8615062791355

Other Identifiers

20221031

Identifier Type: -

Identifier Source: org_study_id