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

NCT07275450 | Recruiting

• 1 other identifier: 1841
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Anesthesia , Analgesia; Ultrasound Guided Nerve Block

Keywords

Ultrasound guided regional anesthesia; General anesthesia; Awake tympanoplasty

Outcome Measures

Primary Outcomes (1)

• The time of discharge from Post Anesthesia Care Unit (PACU)

  The time from arrival to the Post Anesthesia Care Unit (PACU) to the time to discharge to the ward according to modified aldrete score

  2 hours postoperative

Secondary Outcomes (10)

• Intraoperative mean arterial blood pressure

  0 minute (basal) and every 5 minutes up to 2 hours

• Pain intensity by using Numerical Rating Scale (NRS)

  Post Anesthesia Care Unit (0 hour) , 2 hours, 4 hours, 8 hours, 12 hours and 24 hours

• Block success rate

  15-20 minutes (from finishing block till start surgery)

• Quality of surgical field

  duration of surgery (intraoperative)

• Time to first request of analgesia

  24 hours

Study Arms (2)

Ultrasound-guided regional anesthesia group

ACTIVE COMPARATOR

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.

Procedure: Ultrasound-guided regional anesthesia group

Control group

SHAM COMPARATOR

patients will receive general anesthesia

Other: Control group

Interventions

Control group OTHER

patients will receive general anesthesia.

Control group

Ultrasound-guided regional anesthesia group 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.

Ultrasound-guided regional anesthesia group

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients acceptance
• Age: 21-65 years old
• Sex: both sex (males or females).
• Physical status: American Society Anesthesiologist (ASA) І and II.
• Patients will be scheduled for elective unilateral tympanoplasty.

You may not qualify if:

• Contraindication of regional anesthesia: Coagulopathy or use of anticoagulant therapy -local infection at the site of injection- known allergy to local anesthetics (bupivacaine).
• Neurological disorders affecting sensation in the head and neck.
• Psychiatric illness, severe anxiety, or inability to cooperate during awake surgery.
• History of previous neck or parotid surgery affecting nerve anatomy.
• BMI \> 35 (if it may interfere with ultrasound visualization or landmark identification).
• Pregnancy.
• Advanced cardiovascular, respiratory, hepatic and renal diseases

Sponsors & Collaborators

• Zagazig University: lead

Study Sites (1)

faculty of human medicine, Zagazig university hospitals

Zagazig, Egypt

RECRUITING

MeSH Terms

Conditions

Agnosia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Central Study Contacts

Dina Salem, MD

CONTACT

0109933513; dinamaghraby@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor of anesthesia

Model Details: To evaluate ultrasound-guided regional anesthesia versus general anesthesia in patients undergoing tympanoplasty

Study Record Dates

• First Submitted: November 25, 2025
• First Posted: December 10, 2025
• Study Start: December 10, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: December 11, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)