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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