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

December 10, 2025 updated by: Dina Abdelhameed Elsadek Salem, Zagazig University

Safety and Efficacy of Regional Anesthesia for Awake Tympanoplasty Surgery: A Randomized Controlled Trial

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Estimated)

128

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
      • Zagazig, Egypt
        • Recruiting
        • faculty of human medicine, Zagazig university hospitals
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Procedure: 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.
Sham Comparator: Control group
patients will receive general anesthesia
Other: Control group
patients will receive general anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The time of discharge from Post Anesthesia Care Unit (PACU)
Time Frame: 2 hours postoperative
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative mean arterial blood pressure
Time Frame: 0 minute (basal) and every 5 minutes up to 2 hours
Intraoperative changes in mean arterial blood pressure (mmHg)
0 minute (basal) and every 5 minutes up to 2 hours
Pain intensity by using Numerical Rating Scale (NRS)
Time Frame: Post Anesthesia Care Unit (0 hour) , 2 hours, 4 hours, 8 hours, 12 hours and 24 hours
It is a scale from 0 to 10, where 0=no pain and 10= worst pain
Post Anesthesia Care Unit (0 hour) , 2 hours, 4 hours, 8 hours, 12 hours and 24 hours
Block success rate
Time Frame: 15-20 minutes (from finishing block till start surgery)
The number of patients converted to general anesthesia
15-20 minutes (from finishing block till start surgery)
Quality of surgical field
Time Frame: duration of surgery (intraoperative)
quality of surgical field by Modena Bleeding Score (MBS) is a validated categorical scale designed to measure the quality of the surgical field in relation to bleeding during endoscopic surgery. It features five grades (1= no bleeding, 2= bleeding easily controlled by suction, 3= bleeding that slows surgical procedure, 4= most maneuvers are dedicated to bleeding control and 5= bleeding is so sever that only procedures aimed at controlling bleeding)
duration of surgery (intraoperative)
Time to first request of analgesia
Time Frame: 24 hours
Time to first request of analgesia (pethidine)
24 hours
Total postoperative analgesic consumption
Time Frame: 24 hours
total postoperative pethidine consumption
24 hours
Patient satisfaction by Likert score
Time Frame: 24 hours
patient satisfaction by Likert score: The patients will be asked to rate the overall degree of satisfaction of the analgesia by using a 5-points Likert-like verbal scale (1 = very dissatisfied analgesia, 2 = dissatisfied analgesia, and 3 = neutral, 4=satisfied analgesia, and 5=very satisfied analgesia)
24 hours
Surgeon satisfaction
Time Frame: duration of surgery (intraoperative)
Surgeon satisfaction by asking the surgeon to rate satisfaction at the end of surgery (4 =excellent, 3=good, 2=fair, 1=poor, 0=extremely poor)
duration of surgery (intraoperative)
The incidence of block-related complications or surgery related complications
Time Frame: 24 hours
To assess the incidence of block-related complications, such as nerve injury, hematoma, inadequate block, or local anesthetic toxicity or surgery related complications (e.g. nausea and vomiting)
24 hours
Intraoperative heart rate ( beat per minute)
Time Frame: before starting anesthesia 0 minute (basal )and every 5 minutes up to 2 hours
measure intraoperative changes in heart rate
before starting anesthesia 0 minute (basal )and every 5 minutes up to 2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Zagazig University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 10, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

November 25, 2025

First Submitted That Met QC Criteria

December 7, 2025

First Posted (Estimated)

December 10, 2025

Study Record Updates

Last Update Posted (Actual)

December 11, 2025

Last Update Submitted That Met QC Criteria

December 10, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1841

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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