Comparative Study Between Ultrasound Guided Regional Anesthesia for Awake Tympanoplasty Surgery vs General Anesthesia

NCT ID: NCT07275450

Last Updated: 2025-12-11

Study Results

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-10

Study Completion Date

2026-10-01

Brief Summary

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The aim of this study to evaluate efficacy of ultrasound guided regional anesthesia in performing awake tympanoplasty surgery versus traditional general anesthesia

Detailed Description

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* To evaluate ultrasound-guided regional anesthesia versus general anesthesia in patients undergoing tympanoplasty as regards:
* 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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Ultrasound Guided Nerve Block Anesthesia , Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

To evaluate ultrasound-guided regional anesthesia versus general anesthesia in patients undergoing tympanoplasty
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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.

Group Type ACTIVE_COMPARATOR

Ultrasound-guided regional anesthesia group

Intervention Type PROCEDURE

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

Group Type SHAM_COMPARATOR

Control group

Intervention Type OTHER

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.

Intervention Type PROCEDURE

Control group

patients will receive general anesthesia.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Patients acceptance
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

1. Contraindication of regional anesthesia: Coagulopathy or use of anticoagulant therapy -local infection at the site of injection- known allergy to local anesthetics (bupivacaine).
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
Minimum Eligible Age

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zagazig University

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dina Abdelhameed Elsadek Salem

Associate professor of anesthesia

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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faculty of human medicine, Zagazig university hospitals

Zagazig, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Dina Salem, MD

Role: CONTACT

0109933513 ext. 002

Facility Contacts

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Ahmed Hegab, MD

Role: primary

01000089347 ext. 002

Other Identifiers

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1841

Identifier Type: -

Identifier Source: org_study_id

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