Impact of Interscalenous Block Anesthesia on Hearing

NCT06430463 | Completed

• 1 other identifier: 02-2024/11
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss

Keywords

hearing level; interscalene block anesthesia

Outcome Measures

Primary Outcomes (1)

• 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

  pre-surgery, a day after surgery

Study Arms (1)

patients undergoing shoulder surgery with interscalene block

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

Interventions

pure tone audiometry levels DIAGNOSTIC_TEST

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

patients undergoing shoulder surgery with interscalene block

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants undergoing shoulder surgery with ultrasoun-guided interscalene brachial plexus block.

You may qualify if:

• participants are undergoing a shoulder surgery.
• ASA I and II patients without uncontrolled diabetes and hypertension
• participants have normal or near-normal hearing thresholds in the un-operated ear

You may not qualify if:

• participants have hearing loss (PTA \> 35 dB HL) in pure tone audiometry testing before surgery in any side
• participants have medical conditions after the surgery which prevents having hearing tests
• participants have abnormal tympanometric results
• participants with chronic otitis media or a history of ear surgery

Sponsors & Collaborators

• Karaman Training and Research Hospital: lead

Study Sites (1)

Karaman training and research hospital

Karaman, Merkez, 70200, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hearing Loss

Interventions

Audiometry, Speech; Acoustic Impedance Tests

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Audiometry; Hearing Tests; Diagnostic Techniques, Otological; Diagnostic Techniques and Procedures; Diagnosis

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2024
• First Posted: May 28, 2024
• Study Start: June 5, 2024
• Primary Completion: October 24, 2024
• Study Completion: November 5, 2024
• Last Updated: April 1, 2025

Record last verified: 2024-10

Locations

TU (1)