Greater auricular nerve block to reduce agitation after children's 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

This trial will test whether an ultrasound-guided greater auricular nerve block can reduce agitation and pain when children wake up after microscopic middle ear surgery.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 74 (estimated)
• Ages: 5 Years to 14 Years
• Sex: All
• Sponsor: Fayoum University (other)
• Locations: 1 site (Al Fayyum, Faiyum Governorate)
• Trial ID: NCT07435675 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Children aged 5–14 years with ASA I–II scheduled for elective microscopic middle ear surgery who can be assessed with FLACC and PAED scores and whose parent or guardian provides consent.

Not a fit: Children with developmental or neurological disorders, significant hearing or communication impairment, allergy to amide local anesthetics, active infection at the block site, or those undergoing emergency/combined procedures are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, the nerve block could lower the frequency and severity of emergence agitation and reduce postoperative pain and related complications in children after middle ear surgery.

How similar studies have performed: Ultrasound-guided GAN blocks have been used successfully for postoperative analgesia in related adult and pediatric ear and parotid surgeries, but direct evidence specifically preventing pediatric emergence agitation after middle ear surgery is limited.

Eligibility criteria

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 this trial is running

Al Fayyum, Faiyum Governorate

• Fayoum University Hospital — Al Fayyum, Faiyum Governorate, Egypt (RECRUITING)

Study contacts

• Study coordinator: abdalla moustafa abdelhamid, MBBCH

Conditions: Emergence Agitation, Emergence Delirium, Anesthesia, Emergence From Anesthesia, Emergence Delirium, Emergence Delirium in Pediatric Anesthesia, Emergence Agitation, Post Operative Behavioral Changes, emergence agitation, emergence delirium