Comparative Study Between Ultrasound Guided Regional Anesthesia for Awake Tympanoplasty Surgery vs General Anesthesia
NCT ID: NCT07275450
Last Updated: 2025-12-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
128 participants
INTERVENTIONAL
2025-12-10
2026-10-01
Brief Summary
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Detailed Description
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* To assess the time of discharge from post anesthesia care unit
* To assess intraoperative hemodynamic parameters, quality of the surgical field and the block success rate (number of patients converted to general anesthesia).
* To assess postoperative parameters: Numerical Rating Scale , time to first request of analgesia, postoperative opioid consumption, patient and surgeon satisfaction in both groups.
* To assess the incidence of block-related complications (such as nerve injury, hematoma, inadequate block, or local anesthetic toxicity) or surgery related complications as nausea and vomiting
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Ultrasound-guided regional anesthesia group
patients will receive regional anesthesia using ultrasound guidance. Target nerves (e.g., great auricular nerve, auriculotemporal nerve and lesser occipital nerve) will be identified and anesthetized under real-time ultrasound visualization to ensure accurate needle placement and local anesthetic spread.
Ultrasound-guided regional anesthesia group
patients will receive regional anesthesia using ultrasound guidance. Target nerves (e.g., great auricular nerve, auriculotemporal nerve and lesser occipital nerve) will be identified and anesthetized under real-time ultrasound visualization to ensure accurate needle placement and local anesthetic spread.
Control group
patients will receive general anesthesia
Control group
patients will receive general anesthesia.
Interventions
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Ultrasound-guided regional anesthesia group
patients will receive regional anesthesia using ultrasound guidance. Target nerves (e.g., great auricular nerve, auriculotemporal nerve and lesser occipital nerve) will be identified and anesthetized under real-time ultrasound visualization to ensure accurate needle placement and local anesthetic spread.
Control group
patients will receive general anesthesia.
Eligibility Criteria
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Inclusion Criteria
2. Age: 21-65 years old
3. Sex: both sex (males or females).
4. Physical status: American Society Anesthesiologist (ASA) І and II.
5. Patients will be scheduled for elective unilateral tympanoplasty.
Exclusion Criteria
2. Neurological disorders affecting sensation in the head and neck.
3. Psychiatric illness, severe anxiety, or inability to cooperate during awake surgery.
4. History of previous neck or parotid surgery affecting nerve anatomy.
5. BMI \> 35 (if it may interfere with ultrasound visualization or landmark identification).
6. Pregnancy.
7. Advanced cardiovascular, respiratory, hepatic and renal diseases
21 Years
65 Years
ALL
Yes
Sponsors
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Zagazig University
OTHER_GOV
Responsible Party
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Dina Abdelhameed Elsadek Salem
Associate professor of anesthesia
Locations
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faculty of human medicine, Zagazig university hospitals
Zagazig, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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1841
Identifier Type: -
Identifier Source: org_study_id
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