Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06430463
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-21
Brief Title:
Impact of Interscalenous Block Anesthesia on Hearing
Sponsor:
Karaman Training and Research Hospital
Organization:
Karaman Training and Research Hospital
Study Overview
Official Title:
Effect of Interscalenous Block Anesthesia on Hearing Levels
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 recordedThe same tests will be performed at the next day after the surgery but before the discharge and also when heshe 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
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 recordedThe same tests will be performed at the next day after the surgery but before the discharge and also when heshe 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None