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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура ultrasound-guided greater auricular nerve block (GANB)
  ultrasound-guided greater auricular nerve block (GANB)

Первичные конечные точки

• score on Pediatric Anesthesia Emergence Delirium (PAED) scale. [Срок оценки: Every 5 minutes for the first 30 minutes post-extubation, then every 15 minutes up to 2 hours postoperative.]

Вторичные конечные точки (6)

• Time to emergence [Срок оценки: From cessation of anesthetic agent until emergence (defined as response to verbal command), assessed up to 60 minutes.]
• Postoperative pain intensity [Срок оценки: Post-extubation up to 2 hours.]
• Requirement for rescue analgesia or rescue sedation [Срок оценки: Postoperative from emergence up to 2 hours.]
• Total PACU stay duration [Срок оценки: from emergence up to 3 hours.]
• Incidence of postoperative nausea and vomiting (PONV) [Срок оценки: From emergence up to 2 hours.]
• Incidence of oxygen desaturation (SpO₂ <94%) [Срок оценки: from emergence up to 2 hours.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

Египет · 1 центр

• Fayoum University Hospital — Al Fayyum

Публикации

• Wei B, Feng Y, Chen W, Ren D, Xiao D, Chen B. Risk factors for emergence agitation in adults after general anesthesia: A systematic review and meta-analysis. Acta Anaesthesiol Scand. 2021 Jul;65(6):719-729. doi: 10.1111/aas.13774. Epub 2021 Jan 7. PMID 33370461
• Suresh S, Ecoffey C, Bosenberg A, Lonnqvist PA, de Oliveira GS Jr, de Leon Casasola O, de Andres J, Ivani G. 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. Reg Anesth Pain Med. 2018 Feb;43(2):211-216. doi: 10.1097/AAP.0000000000000702. PMID 29319604
• Flores S, Herring AA. Ultrasound-guided Greater Auricular Nerve Block for Emergency Department Ear Laceration and Ear Abscess Drainage. J Emerg Med. 2016 Apr;50(4):651-5. doi: 10.1016/j.jemermed.2015.10.003. Epub 2015 Nov 14. PMID 26589558
• Voepel-Lewis T, Malviya S, Tait AR. A prospective cohort study of emergence agitation in the pediatric postanesthesia care unit. Anesth Analg. 2003 Jun;96(6):1625-1630. doi: 10.1213/01.ANE.0000062522.21048.61. PMID 12760985
• Dahmani S, Delivet H, Hilly J. Emergence delirium in children: an update. Curr Opin Anaesthesiol. 2014 Jun;27(3):309-15. doi: 10.1097/ACO.0000000000000076. PMID 24784918
• Urits I, Peck J, Giacomazzi S, Patel R, Wolf J, Mathew D, Schwartz R, Kassem H, Urman RD, Kaye AD, Viswanath O. Emergence Delirium in Perioperative Pediatric Care: A Review of Current Evidence and New Directions. Adv Ther. 2020 May;37(5):1897-1909. doi: 10.1007/s12325-020-01317-x. Epub 2020 Apr 9. PMID 32274749

Идентификаторы

NCT: NCT07435675 · M824

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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