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This randomized double-blind controlled trial aims to evaluate whether bilateral trans-nasal sphenopalatine ganglion block (SPGB) using bupivacaine reduces the incidence of emergence agitation following Functional Endoscopic Sinus Surgery (FESS) compared with placebo. Secondary objectives include evaluation of postoperative pain, postoperative opioid consumption, hemodynamic parameters, postoperative nausea and vomiting, and adverse events.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group (SPGB) | Experimental | Bilateral trans-nasal SPGB performed under direct endoscopic visualization using 1.5 mL of 0.5% bupivacaine per side. |
|
| Placebo Comparator Group (C) | Placebo Comparator | Bilateral trans-nasal sham injection performed under direct endoscopic visualization using 1.5 mL normal saline per side. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bilateral Trans-nasal Sphenopalatine Ganglion Block | Procedure | Bilateral trans-nasal sphenopalatine ganglion block performed under direct endoscopic visualization using 1.5 mL of 0.5% bupivacaine per side. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Emergence Agitation | Incidence of emergence agitation, defined as a Richmond Agitation-Sedation Scale (RASS) score ≥ +2 at any time during the first 30 minutes in the post-anesthesia care unit (PACU). | first 30 minutes in the post-anesthesia care unit (PACU). |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain Scores | Pain intensity assessed using the Visual Analog Scale (VAS). | first 30 minutes in the post-anesthesia care unit (PACU) |
| Postoperative Fentanyl Consumption | Total postoperative fentanyl requirement administered for rescue analgesia. |
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Inclusion Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Amir Mostafa Shabana, MD | Faculty of Medicine, Mansoura University, Mansoura, Egypt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura University Hospitals | Al Mansurah | Dakahlia Governorate | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21739090 | Background | Kesimci E, Ozturk L, Bercin S, Kiris M, Eldem A, Kanbak O. Role of sphenopalatine ganglion block for postoperative analgesia after functional endoscopic sinus surgery. Eur Arch Otorhinolaryngol. 2012 Jan;269(1):165-9. doi: 10.1007/s00405-011-1702-z. Epub 2011 Jul 8. | |
| 33388988 | Background | Wang P. The efficacy of sphenopalatine ganglion block for pain management after endoscopic sinus surgery: a meta-analysis of randomized controlled studies. Eur Arch Otorhinolaryngol. 2021 Aug;278(8):2681-2687. doi: 10.1007/s00405-020-06484-9. Epub 2021 Jan 3. |
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The study solution was prepared in identical syringes by a scrub nurse who was not involved in patient management, outcome assessment, data collection, or statistical analysis. Participants, the surgeon performing the block and surgery, the attending anesthesiologist, outcome assessors, investigators, and the statistician remained blinded to treatment allocation throughout the study.
|
| Sham Trans-nasal Injection | Procedure | Bilateral trans-nasal sham injection performed under direct endoscopic visualization using 1.5 mL of normal saline per side. |
|
|
| first 30 minutes in the post-anesthesia care unit (PACU) |
| Mean Arterial Blood Pressure | Intraoperative and postoperative mean arterial blood pressure measurements. | From induction of anesthesia until first 30 minutes in the post-anesthesia care unit (PACU) |
| Heart Rate | Intraoperative and postoperative heart rate measurements. | From induction of anesthesia until first 30 minutes in the post-anesthesia care unit (PACU) |
| Incidence of Postoperative Nausea and Vomiting | Occurrence of postoperative nausea and/or vomiting. | first 30 minutes in the post-anesthesia care unit (PACU) |
| Adverse Events | Procedure-related complications including epistaxis, local anesthetic systemic toxicity, diplopia or visual symptoms, palatal numbness, and other adverse events. | From induction of anesthesia until first 30 minutes in the post-anesthesia care unit (PACU) |
| Duration of Surgery | Total operative time measured from surgical incision to completion of surgery. | During surgery |
| 30296912 | Background | Kim DH, Kang H, Hwang SH. The Effect of Sphenopalatine Block on the Postoperative Pain of Endoscopic Sinus Surgery: A Meta-analysis. Otolaryngol Head Neck Surg. 2019 Feb;160(2):223-231. doi: 10.1177/0194599818805673. Epub 2018 Oct 9. |
| 39366653 | Background | Hamed R, Gamal L, Elsawy S, Baker MA, Abbas YH. Efficacy of ultrasound guided sphenopalatine ganglion block in management of emergence agitation after sinoscopic nasal surgery: a randomized double-blind controlled study. Anaesth Crit Care Pain Med. 2024 Dec;43(6):101429. doi: 10.1016/j.accpm.2024.101429. Epub 2024 Oct 2. |
| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| D010149 | Pain, Postoperative |
| 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 |
| D010146 | Pain |
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