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

NCT07435675 | Recruiting DMC

• 1 other identifier: M824
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Emergence Agitation; Emergence Delirium, Anesthesia; Emergence From Anesthesia; Emergence Delirium; Emergence Delirium in Pediatric Anesthesia; Emergence Agitation, Post Operative Behavioral Changes

Keywords

emergence agitation; emergence delirium; EA

Outcome Measures

Primary Outcomes (1)

• score on Pediatric Anesthesia Emergence Delirium (PAED) scale.

  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 Outcomes (6)

• Time to emergence

  From cessation of anesthetic agent until emergence (defined as response to verbal command), assessed up to 60 minutes.

• Postoperative pain intensity

  Post-extubation up to 2 hours.

• Requirement for rescue analgesia or rescue sedation

  Postoperative from emergence up to 2 hours.

• Total PACU stay duration

  from emergence up to 3 hours.

• Incidence of postoperative nausea and vomiting (PONV)

  From emergence up to 2 hours.

Study Arms (2)

group G (GANB group)

EXPERIMENTAL

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)

group C (control group)

NO INTERVENTION

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

Interventions

ultrasound-guided greater auricular nerve block (GANB) PROCEDURE

ultrasound-guided greater auricular nerve block (GANB)

group G (GANB group)

Eligibility Criteria

• Age: 5 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fayoum University: lead

Study Sites (1)

Fayoum University Hospital

Al Fayyum, Faiyum Governorate, 63511, Egypt

RECRUITING

Related Publications (6)

• Wei B, Feng Y, Chen W, Ren D, Xiao D, Chen B. Risk factors for emergence agitation in adults after general anesthesia: A systematic review and meta-analysis. Acta Anaesthesiol Scand. 2021 Jul;65(6):719-729. doi: 10.1111/aas.13774. Epub 2021 Jan 7.

  PMID: 33370461 BACKGROUND

• Suresh S, Ecoffey C, Bosenberg A, Lonnqvist PA, de Oliveira GS Jr, de Leon Casasola O, de Andres J, Ivani G. The European Society of Regional Anaesthesia and Pain Therapy/American Society of Regional Anesthesia and Pain Medicine Recommendations on Local Anesthetics and Adjuvants Dosage in Pediatric Regional Anesthesia. Reg Anesth Pain Med. 2018 Feb;43(2):211-216. doi: 10.1097/AAP.0000000000000702.

  PMID: 29319604 BACKGROUND

• Flores S, Herring AA. Ultrasound-guided Greater Auricular Nerve Block for Emergency Department Ear Laceration and Ear Abscess Drainage. J Emerg Med. 2016 Apr;50(4):651-5. doi: 10.1016/j.jemermed.2015.10.003. Epub 2015 Nov 14.

  PMID: 26589558 BACKGROUND

• Voepel-Lewis T, Malviya S, Tait AR. A prospective cohort study of emergence agitation in the pediatric postanesthesia care unit. Anesth Analg. 2003 Jun;96(6):1625-1630. doi: 10.1213/01.ANE.0000062522.21048.61.

  PMID: 12760985 BACKGROUND

• Dahmani S, Delivet H, Hilly J. Emergence delirium in children: an update. Curr Opin Anaesthesiol. 2014 Jun;27(3):309-15. doi: 10.1097/ACO.0000000000000076.

  PMID: 24784918 BACKGROUND

• Urits I, Peck J, Giacomazzi S, Patel R, Wolf J, Mathew D, Schwartz R, Kassem H, Urman RD, Kaye AD, Viswanath O. Emergence Delirium in Perioperative Pediatric Care: A Review of Current Evidence and New Directions. Adv Ther. 2020 May;37(5):1897-1909. doi: 10.1007/s12325-020-01317-x. Epub 2020 Apr 9.

  PMID: 32274749 BACKGROUND

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• mohamed ahmed Ismail, professor

  Fayoum University

  STUDY CHAIR

Central Study Contacts

abdalla moustafa abdelhamid, MBBCH

CONTACT

00201066743988; am3486@fayoum.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: January 26, 2026
• First Posted: February 27, 2026
• Study Start: August 1, 2025
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: February 27, 2026

Record last verified: 2025-08

Locations

EG (1)