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NCT Number: NCT07275450

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

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

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Key information

Conditions

Ultrasound Guided Nerve Block Agnosia Anesthesia , Analgesia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

faculty of human medicine, Zagazig university hospitals

Zagazig, Egypt

Location status: Recruiting

Location contact

Ahmed Hegab, MD

CONTACT

[email protected]

01000089347 ext. 002

About this study

  • 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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

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.

Control Group

Other

patients will receive general anesthesia.

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. 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

  3. Block success rate

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

    The number of patients converted to general anesthesia

  4. 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)

  5. Time to first request of analgesia

    Time frame: 24 hours

    Time to first request of analgesia (pethidine)

  6. Total postoperative analgesic consumption

    Time frame: 24 hours

    total postoperative pethidine consumption

  7. 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)

  8. 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)

  9. 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)

  10. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Dina Salem, MD

CONTACT

[email protected]

0109933513 ext. 002

Sponsors and collaborators

Lead sponsor

Zagazig University

Other Gov

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 10, 2025
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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