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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| group G (GANB group) | Experimental | 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 |
|
| group C (control group) | No Intervention | 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ultrasound-guided greater auricular nerve block (GANB) | Procedure | ultrasound-guided greater auricular nerve block (GANB) |
|
| Measure | Description | Time Frame |
|---|---|---|
| score on Pediatric Anesthesia Emergence Delirium (PAED) scale. | The Pediatric Anesthesia Emergence Delirium (PAED) scale has 64% sensitivity and 86% specificity. This validated tool includes five items scored on a 5-point Likert scale (eye contact with caregiver, purposeful actions, awareness of surroundings, restlessness, and consolability). Score of ≥10 at any point during the postoperative observation period in the PACU will be considered as an episode of EA. | Every 5 minutes for the first 30 minutes post-extubation, then every 15 minutes up to 2 hours postoperative. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to emergence | It's the time between cessation of any anesthetic agent and emergence, as it contributes to agitation. | From cessation of anesthetic agent until emergence (defined as response to verbal command), assessed up to 60 minutes. |
| Postoperative pain intensity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| abdalla moustafa abdelhamid, MBBCH | Contact | 00201066743988 | am3486@fayoum.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| mohamed ahmed Ismail, professor | Fayoum University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fayoum University Hospital | Recruiting | Al Fayyum | Faiyum Governorate | 63511 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33370461 | Background | 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. | |
| 29319604 | Background | 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. |
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Pain will be evaluated using the Face, Legs, Activity, Cry, Consolability (FLACC) scale, scored from 0 to 10. Pain scores will be assessed:
|
| Post-extubation up to 2 hours. |
| Requirement for rescue analgesia or rescue sedation | If the incidence of EA or pain occurs, medical intervention will be commenced. | Postoperative from emergence up to 2 hours. |
| Total PACU stay duration | this will record time to discharge from PACU. The shorter the time the more favorable the intervention is. | from emergence up to 3 hours. |
| Incidence of postoperative nausea and vomiting (PONV) | PONV is considered an adverse outcome of many factors in perioperative period, including opioid use, pain, preoperative GERD or incomplete hours of fasting. | From emergence up to 2 hours. |
| Incidence of oxygen desaturation (SpO₂ <94%) | Hypoxia may result from aspiration, incomplete recovery from muscle relaxants, oversedation, or preexisting respiratory problems. | from emergence up to 2 hours. |
| 26589558 | Background | 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. |
| 12760985 | Background | 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. |
| 24784918 | Background | 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. |
| 32274749 | Background | 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. |
| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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