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

Sponsor

Zhuan Zhang (Other)

Overall Status

Recruiting

CT.gov ID

NCT05623384

Collaborator

(none)

Enrollment

Location

Arms

10.5

Anticipated Duration (Months)

8.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Sudden Deafness	Procedure: Stellate ganglion block Procedure: Facial and glossopharyngeal nerve blocks Drug: Mecobalamin Tablets	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

90 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Nov 14, 2022

Anticipated Primary Completion Date :

Sep 30, 2023

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Stellate ganglion block combined with facial and glossopharyngeal nerve block group	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） 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） Drug: Mecobalamin Tablets oral Mecobalamin Tablets tid-8
Experimental: Stellate ganglion block group	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） Drug: Mecobalamin Tablets oral Mecobalamin Tablets tid-8
Other: Control group	Drug: Mecobalamin Tablets oral Mecobalamin Tablets tid-8

Arm

Intervention/Treatment

Experimental: Stellate ganglion block combined with facial and glossopharyngeal nerve block group

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）

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）

Drug: Mecobalamin Tablets

oral Mecobalamin Tablets tid-8

Experimental: Stellate ganglion block group

Procedure: Stellate ganglion block

Drug: Mecobalamin Tablets

oral Mecobalamin Tablets tid-8

Other: Control group

Drug: Mecobalamin Tablets

oral Mecobalamin Tablets tid-8

Outcome Measures

Primary Outcome Measures

Mean Hearing Threshold (PTA) [Baseline (Before treatment)，1 month and 2 months after treatment]
The average of hearing thresholds at six frequencies (250, 500, 1000, 2000, 4000, and 8000 Hz) was recorded as the mean hearing threshold (PTA).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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