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

Zagazig University

Status: Enrolling

Conditions: Ultrasound Guided Nerve Block; Anesthesia , Analgesia

Treatments: Other: Control group; Procedure: Ultrasound-guided regional anesthesia group

Study type: Interventional

Funder types: Other

Identifiers

NCT07275450

1841

Details and patient eligibility

About

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

Full description

• 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

Enrollment: 128 estimated patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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128 participants in 2 patient groups

Ultrasound-guided regional anesthesia group

Active Comparator group

Description:

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.

Treatment:

Procedure: Ultrasound-guided regional anesthesia group

Control group

Sham Comparator group

Description:

patients will receive general anesthesia

Treatment:

Other: Control group