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

Fayoum University

Status: Enrolling

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

Treatments: Procedure: ultrasound-guided greater auricular nerve block (GANB)

Study type: Interventional

Funder types: Other

Identifiers

NCT07435675

M824

Details and patient eligibility

About

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.

Full description

Emergence agitation (EA) is one of the Perioperative Neurocognitive Disorders (PND). It's defined as psychomotor agitation and delirium, that typically occurs within the first 45 minutes postoperative. It may present as non-purposeful movements such as kicking and pulling or lack of eye contact or awareness to the surroundings.

EA has been linked to several risk factors, including type of surgery (ENT, ophthalmic), the use of volatile anesthetics (especially sevoflurane) . Middle earsurgeries are especially noteworthy because of their high EA risk owing to significant nociceptive stimulation of the external ear and its surrounding tissues as well. Pain is one of the modifiable risk factors, and studies have demonstrated a strong association between postoperative pain scores and incidence of EA The greater auricular nerve (GAN), originating from the cervical plexus (C2-C3), provides sensory innervation to the inferior two-thirds of the auricle, skin over the mastoid process, angle of the mandible and parotid region (5). All these areas are typically involved in or manipulated for middle ear surgery, and therefore the GAN is an easily identifiable nerve for perioperative analgesia treatment. An ultrasound-guided GAN block has been performed in both adults and pediatric populations to provide analgesia for postoperative pain after parotidectomy, auriculotemporal procedures, and mastoid surgery (6,7).

The strong association between moderate to severe postoperative pain and EA, coupled with the high rate of EA in middle ear procedures, suggest that a safe, focused regional technique could address these issues in this population (8). That in mind, we hypothesize that using an ultrasound-guided technique giving 100% accuracy blocking GAN, will reduce the pain and hence the incidence of EA postoperative.

Enrollment: 74 estimated patients

Sex: All

Ages: 5 to 14 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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74 participants in 2 patient groups

group G (GANB group)

Experimental group

Description:

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

Treatment:

Procedure: ultrasound-guided greater auricular nerve block (GANB)

group C (control group)

No Intervention group

Description:

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