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NCT Number: NCT07435675

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

ultrasound-guided greater auricular nerve block (GANB)

Procedure

ultrasound-guided greater auricular nerve block (GANB)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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)
  3. 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.

  4. 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.

  5. 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.

  6. 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.

Study contacts

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

abdalla moustafa abdelhamid, MBBCH

CONTACT

[email protected]

00201066743988

Sponsors and collaborators

Lead sponsor

Fayoum University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

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

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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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