Greater auricular nerve block to reduce agitation after children's middle ear surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional trial delivers an ultrasound-guided greater auricular nerve block (GANB) to children aged 5–14 undergoing elective microscopic middle ear surgery under general anesthesia. Postoperative emergence agitation (EA) occurrence and severity will be recorded using validated PAED and FLACC scores during the immediate 45-minute recovery period. Patients with neurological or communication impairments, local infection at the block site, or allergy to amide local anesthetics are excluded, and parental consent is required. The study compares postoperative EA and pain-related outcomes after targeted regional analgesia versus typical perioperative care to see if GANB lowers nociceptive-driven agitation.

Why it matters

Who can join: the full rules

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.

Where it's running

• Fayoum University Hospital
  Al Fayyum, Faiyum Governorate, Egypt Recruiting

Study contacts

• Study coordinator: abdalla moustafa abdelhamid, MBBCH
• Email: am3486@fayoum.edu.eg
• Phone: 00201066743988

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.