Actively Recruiting

Phase Not Applicable
Age: 5Years - 14Years
All Genders
Healthy Volunteers
ID07435675

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

Led by Fayoum University · Updated on 2026-02-27

74

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating whether an ultrasound-guided greater auricular nerve block (GANB) can reduce emergence agitation (EA), a common delirium and psychomotor agitation occurring shortly after anesthesia, in children undergoing microscopic middle ear surgery. The study focuses on pediatric patients aged 5 to 14 years, as this group is at higher risk for EA, especially after ear surgeries involving significant pain and nerve stimulation. The trial is designed as a prospective, randomized, double-blinded clinical trial to assess the effect of GANB on EA occurrence and severity. Participants will be randomly assigned to one of two groups. One group will receive a unilateral ultrasound-guided GANB with 0.25% Bupivacaine shortly after anesthesia induction and before surgery begins. The control group will receive no nerve block; however, to maintain blinding, an ultrasound probe will be applied without needle insertion or injection. This procedure aims to compare the effectiveness of the nerve block in reducing postoperative pain and agitation. During the study, children's emergence from anesthesia will be closely monitored using the Pediatric Anesthesia Emergence Delirium (PAED) scale at regular intervals for up to two hours after extubation. Researchers will also measure time to emergence, pain intensity, need for additional pain or sedation medications, post-anesthesia care unit stay length, and incidence of nausea, vomiting, or oxygen desaturation. Participation involves assessments during surgery and recovery, with follow-up lasting up to three hours post-emergence.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 5Years - 14Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 5 and 14 years
  • Physical health classified as ASA I or II
  • Scheduled for elective microscopic middle ear surgery under general anesthesia
  • Ability to comply with pain and agitation scoring during recovery
  • Informed consent provided by a parent or legal guardian
Not Eligible

You will not qualify if you...

  • Known neurological, developmental, or psychiatric disorders such as autism, ADHD, or seizure disorder
  • Allergic reaction to amide local anesthetics like lidocaine or bupivacaine
  • Skin infection, hematoma, or injury near the proposed nerve block site
  • Emergency or combined surgeries
  • Inability to assess pain or agitation due to hearing loss or communication issues
  • Refusal of participation by parent or legal guardian

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Treatment

Duration - Single day of surgery

Participants receive either an ultrasound-guided greater auricular nerve block (GANB) or a sham procedure immediately after induction of general anesthesia and prior to surgical incision during microscopic middle ear surgery.

1 visit (in-person) on surgery day

Post-operative Follow-up

Duration - Up to 3 hours postoperative

Participants are monitored for emergence agitation, pain intensity, and other recovery parameters for up to 3 hours after surgery.

Observations every 5 minutes for the first 30 minutes, then every 15 minutes up to 2 hours post-extubation

Trial Site Locations

Total: 1 location

1

Fayoum University Hospital

Al Fayyum, Faiyum Governorate, Egypt, 63511

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Research Team

A

abdalla moustafa abdelhamid, MBBCH

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

2

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Published Research Related To This Trial

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.

Santhanam Suresh, Claude Ecoffey, Adrian Bosenberg...

https://pubmed.ncbi.nlm.nih.gov/29319604