RecruitingNot ApplicableNCT07435675

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

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


Sponsor

Fayoum University

Enrollment

74 participants

Start Date

Aug 1, 2025

Study Type

INTERVENTIONAL

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.


Eligibility

Min Age: 5 YearsMax Age: 14 Years

Inclusion Criteria5

  • 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 Criteria6

  • 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.

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Interventions

PROCEDUREultrasound-guided greater auricular nerve block (GANB)

ultrasound-guided greater auricular nerve block (GANB)


Locations(1)

Fayoum University Hospital

Al Fayyum, Faiyum Governorate, Egypt

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NCT07435675