An observational study in Hearing Loss, sponsored by Karaman Training and Research Hospital. Completed at 1 site in Turkey. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-04-01.
Sponsored by Karaman Training and Research Hospital · Observational
Interscalene brachial plexus block (ISBPB) is used frequently in shoulder, clavicle and upper arm surgeries to obtain analgesia in the postoperative period. Our primary aim in this study is to evaluate if interscalene block anesthesia has an effect on hearing levels of patients undergoing orthopedic shoulder surgeries.
Interscalene brachial plexus block (ISBPB) is used for both anesthesia and analgesia purposes in shoulder, clavicle and upper arm surgeries. It is also frequently used to obtain analgesia in the postoperative period especially in patients undergoing shoulder surgeries. Thus, it provides decrease in opioid need and opioid related side effects in the perioperative period. The effect of IBPB on hearing is probably not caused by an effect on the vestibulocochlear nerve because of its central location. The innervation area of the greater auricular nerve, a derivative of the cervical plexus, is often involved in an IBPB. However, this nerve is not known to affect hearing. The nerves supplying the outer ear canal and the tympanic membrane (branches of the mandibular, facial and vagal nerves) are located far enough from the IBPB injection site to make their involvement unlikely. However, sound conduction through the middle ear to the inner ear, and functioning of the spiral organ of the cochlea may be indirectly affected by regional sympathetic block that is most likely seen after IBPB. Sympathetic block may cause vasodilatation and swelling of the mucosal membranes of the middle ear and the eustachian tube with deterioration of hearing.
The patient will be examined by ENT physician on the morning of the operation, after a detailed anamnesis. otoscopic examination will be performed, pure tone audiometry, speech audiometry and tympanometric examination will be performed and recorded.The same tests will be performed at the next day after the surgery but before the discharge and also when he/she applies for the first week check-up. Ultrasaoun guided Interscalene block anesthesia will be applied to all patients. Each patient will be treated with the same multimodal analgesia method at the postoperative period.
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This study's enrollment of 50 is below the median of 87 across 270 observational studies indexed under Hearing Loss.
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Participants undergoing shoulder surgery with ultrasoun-guided interscalene brachial plexus block.
Exclusion Criteria:
Ultrasound-guided Interscalene block will be applied to all patientsand also every patients will be treated with the same multimodal analgesia for postoperative pain control. The patient will be examined by ENT physician on the morning of the operation, after a detailed anamnesis. otoscopic examination will be performed, pure tone audiometry, speech audiometry and tympanometric examination will be performed and recorded.The same tests will be performed at the next day after the surgery but before the discharge and also when he/she applies for the first week check-up.
Diagnostic Test: pure tone audiometry levels
The patient will be examined by ENT physician on the morning of the operation, otoscopic examination will be performed, pure tone audiometry, speech audiometry and tympanometric examination will be performed and recorded.The same tests will be performed at the next day after the surgery but before the discharge and also when he/she applies for the first week check-up.
Also known as: speech audiometry, tympanometry, otoscopic examnation
Number of Participants with a Difference of 10 dB or more between Pre- and Post-surgery pure tone audiometry measurements at any Frequency
pure tone audiometry measurements at all frequencies measured via MADSEN Astera2 device
Time frame: pre-surgery, a day after surgery
Plan to share: Undecided
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This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Karaman Training and Research Hospital