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Status unknownNCT05623384Updated Nov 21, 2022

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

An interventional study of Stellate ganglion block and Facial and glossopharyngeal nerve blocks in Sudden Deafness, sponsored by Zhuan Zhang. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-11-21.

Sponsored by Zhuan Zhang · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Nov 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
90
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Sudden Deafness

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Keywords

  • Sudden deafness
  • Stellate Ganglion Block
  • Facial nerve block
  • Glossopharyngeal nerve block
03

In context

Hearing Loss, Sudden

49 studies on the registry are indexed under Hearing Loss, Sudden; 21 are open to participants now.

This study's planned enrollment of 90 is above the median of 72 across 39 interventional studies indexed under Hearing Loss, Sudden.

Browse Hearing Loss, Sudden studies →

Lead sponsor

Zhuan Zhang is the lead sponsor of 16 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
90 participants (estimated)

Study arms

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

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

  • Experimental
    Stellate ganglion block group

    Procedure: Stellate ganglion block · Drug: Mecobalamin Tablets

  • Other
    Control group

    Drug: Mecobalamin Tablets

Interventions

  • ProcedureStellate 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)

  • ProcedureFacial 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)

  • oral Mecobalamin Tablets tid-8

06

What researchers measure

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).

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

07

Study locations

1 of 1 sites recruiting
  • the Affiliated Hospital of Yangzhou University
    Yangzhou, Jiangsu, China
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05623384
Lead sponsor
Zhuan Zhang
Responsible party
Zhuan Zhang (Clinical Professor, Yangzhou University) — Sponsor-investigator
First posted
Nov 21, 2022
Start date
Nov 14, 2022
Primary completion
Sep 30, 2023 (estimated)
Completion
Sep 30, 2023 (estimated)
Last update
Nov 21, 2022

Study contacts

zhuan zhang, professor
Contact
zhangzhuancg@163.com
+8615062791355
zhuan zhang, professor
principal investigator · Yangzhou University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.

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