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

NCT ID: NCT05623384

Condition: Sudden Deafness

Conditions: Official terms:
Ganglion Cysts
Deafness
Hearing Loss
Hearing Loss, Sudden

Conditions: Keywords:
Sudden deafness
Stellate Ganglion Block
Facial nerve block
Glossopharyngeal nerve block

Study type: Interventional

Study phase: N/A

Overall status: Unknown status

Study design:

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Prevention

Masking: Triple (Participant, Investigator, Outcomes Assessor)

Intervention:

Intervention type: Procedure
Intervention name: Stellate ganglion block
Description: 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)
Arm group label: Stellate ganglion block combined with facial and glossopharyngeal nerve block group
Arm group label: Stellate ganglion block group

Intervention type: Procedure
Intervention name: Facial and glossopharyngeal nerve blocks
Description: 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)
Arm group label: Stellate ganglion block combined with facial and glossopharyngeal nerve block group

Intervention type: Drug
Intervention name: Mecobalamin Tablets
Description: oral Mecobalamin Tablets tid-8
Arm group label: Control group
Arm group label: Stellate ganglion block combined with facial and glossopharyngeal nerve block group
Arm group label: Stellate ganglion block group

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: the Affiliated Hospital of Yangzhou University

Address:
City: Yangzhou
Country: China

Status: Recruiting

Contact:
Last name: zhuan zhang, professor

Phone: +8615062791355

Phone ext: +8615062791355
Email: zhangzhuancg@163.com

Start date: November 14, 2022

Completion date: September 30, 2023

Lead sponsor:
Agency: Zhuan Zhang
Agency class: Other

Source: Yangzhou University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05623384

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