Efficacy of Ultrasound-guided Greater Auricular Nerve Block in Preventing Postoperative Emergence Agitation in Pediatric Patients Undergoing Microscopic Middle Ear Surgery.

February 23, 2026 updated by: Abdalla Moustafa Hassan Abdelhamid, Fayoum University

Efficacy of Ultrasound-guided Greater Auricular Nerve Block in Preventing Postoperative Emergence Agitation in Pediatric Patients Undergoing Microscopic Middle Ear Surgery: A PROSPECTIVE RANDOMIZED DOUBLE- BLINDED CLINICAL TRIAL

This study is designed to evaluate the effectiveness of ultrasound-guided greater auricular nerve block (GAN) on the reduction of emergence agitation (EA) occurrence and EA severity in children who are receiving general anesthesia for a microscopic middle ear operation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Emergence agitation (EA) is one of the Perioperative Neurocognitive Disorders (PND). It's defined as psychomotor agitation and delirium, that typically occurs within the first 45 minutes postoperative. It may present as non-purposeful movements such as kicking and pulling or lack of eye contact or awareness to the surroundings.

EA has been linked to several risk factors, including type of surgery (ENT, ophthalmic), the use of volatile anesthetics (especially sevoflurane) . Middle earsurgeries are especially noteworthy because of their high EA risk owing to significant nociceptive stimulation of the external ear and its surrounding tissues as well. Pain is one of the modifiable risk factors, and studies have demonstrated a strong association between postoperative pain scores and incidence of EA The greater auricular nerve (GAN), originating from the cervical plexus (C2-C3), provides sensory innervation to the inferior two-thirds of the auricle, skin over the mastoid process, angle of the mandible and parotid region (5). All these areas are typically involved in or manipulated for middle ear surgery, and therefore the GAN is an easily identifiable nerve for perioperative analgesia treatment. An ultrasound-guided GAN block has been performed in both adults and pediatric populations to provide analgesia for postoperative pain after parotidectomy, auriculotemporal procedures, and mastoid surgery (6,7).

The strong association between moderate to severe postoperative pain and EA, coupled with the high rate of EA in middle ear procedures, suggest that a safe, focused regional technique could address these issues in this population (8). That in mind, we hypothesize that using an ultrasound-guided technique giving 100% accuracy blocking GAN, will reduce the pain and hence the incidence of EA postoperative.

Study Type

Interventional

Enrollment (Estimated)

74

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
    • Faiyum Governorate
      • Al Fayyum, Faiyum Governorate, Egypt, 63511
        • Recruiting
        • Fayoum University hospital
        • 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

  • Child

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Age between 5 and 14 years (preschool to early school age group at highest risk for EA).
  • ASA physical status I or II.
  • Scheduled for elective microscopic middle ear surgery under general anesthesia (e.g., tympanoplasty, myringoplasty).
  • Ability to comply with FLACC and PAED scoring during postoperative period.
  • Informed consent obtained from a parent or legal guardian.

Exclusion Criteria:

  • Known neurological, developmental, or psychiatric disorders (e.g., autism, ADHD, seizure disorder).
  • Known hypersensitivity to amide local anesthetics (e.g., lidocaine, bupivacaine).
  • Skin infection, hematoma, or trauma at or near the proposed block site.
  • Non-elective (emergency) or combined surgeries.
  • Inability to assess pain or agitation due to hearing loss, or communication impairment.
  • Parental or legal guardian refusal to participate.

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: group G (GANB group)
Patients in this group will receive a unilateral ultrasound-guided greater auricular nerve block (GANB) on the operative side, with a 0.5-1.5 mg/kg 0.25% Bupivacaine, immediately after induction of general anesthesia and prior to surgical incision
Procedure: ultrasound-guided greater auricular nerve block (GANB)
ultrasound-guided greater auricular nerve block (GANB)
No Intervention: group C (control group)
Patients in this group will receive no nerve block, to maintain blinding, the ultrasound probe will be applied to the same anatomical region with no needle insertion or injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
score on Pediatric Anesthesia Emergence Delirium (PAED) scale.
Time Frame: Every 5 minutes for the first 30 minutes post-extubation, then every 15 minutes up to 2 hours postoperative.
The Pediatric Anesthesia Emergence Delirium (PAED) scale has 64% sensitivity and 86% specificity. This validated tool includes five items scored on a 5-point Likert scale (eye contact with caregiver, purposeful actions, awareness of surroundings, restlessness, and consolability). Score of ≥10 at any point during the postoperative observation period in the PACU will be considered as an episode of EA.
Every 5 minutes for the first 30 minutes post-extubation, then every 15 minutes up to 2 hours postoperative.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to emergence
Time Frame: From cessation of anesthetic agent until emergence (defined as response to verbal command), assessed up to 60 minutes.
It's the time between cessation of any anesthetic agent and emergence, as it contributes to agitation.
From cessation of anesthetic agent until emergence (defined as response to verbal command), assessed up to 60 minutes.
Postoperative pain intensity
Time Frame: Post-extubation up to 2 hours.

Pain will be evaluated using the Face, Legs, Activity, Cry, Consolability (FLACC) scale, scored from 0 to 10. Pain scores will be assessed:

  • At 5-minute intervals during the first 30 minutes post-extubation
  • Then every 15 minutes until PACU discharge
  • FLACC ≥4 will trigger rescue analgesia with IV nalbuphine (0.1 mg/kg)
Post-extubation up to 2 hours.
Requirement for rescue analgesia or rescue sedation
Time Frame: Postoperative from emergence up to 2 hours.
If the incidence of EA or pain occurs, medical intervention will be commenced.
Postoperative from emergence up to 2 hours.
Total PACU stay duration
Time Frame: from emergence up to 3 hours.
this will record time to discharge from PACU. The shorter the time the more favorable the intervention is.
from emergence up to 3 hours.
Incidence of postoperative nausea and vomiting (PONV)
Time Frame: From emergence up to 2 hours.
PONV is considered an adverse outcome of many factors in perioperative period, including opioid use, pain, preoperative GERD or incomplete hours of fasting.
From emergence up to 2 hours.
Incidence of oxygen desaturation (SpO₂ <94%)
Time Frame: from emergence up to 2 hours.
Hypoxia may result from aspiration, incomplete recovery from muscle relaxants, oversedation, or preexisting respiratory problems.
from emergence up to 2 hours.

Collaborators and Investigators

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

Sponsor

Fayoum University

Investigators

  • Study Chair: mohamed ahmed Ismail, professor, Fayoum University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 1, 2025

Primary Completion (Estimated)

April 1, 2026

Study Completion (Estimated)

April 1, 2026

Study Registration Dates

First Submitted

January 26, 2026

First Submitted That Met QC Criteria

February 23, 2026

First Posted (Actual)

February 27, 2026

Study Record Updates

Last Update Posted (Actual)

February 27, 2026

Last Update Submitted That Met QC Criteria

February 23, 2026

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M824

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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