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This prospective, randomized, double-blind clinical trial aims to compare the postoperative analgesic efficacy and recovery outcomes of infraorbital-infratrochlear nerve block and transnasal sphenopalatine ganglion block in patients undergoing septorhinoplasty under general anesthesia. Adult patients aged 18-65 years with ASA I-II status will be randomized to receive either bilateral infraorbital-infratrochlear block or transnasal sphenopalatine ganglion block after induction of anesthesia. Postoperative outcomes including pain scores (NRS at 0-2 h, 2-8 h, and 8-24 h), emergence agitation, Riker Sedation-Agitation Scale (RSAS) scores, time to first rescue analgesic, total tramadol consumption, adverse events, surgical site complications, and patient satisfaction will be assessed and compared between groups.
This study is designed to evaluate the postoperative analgesic efficacy and clinical outcomes of two regional anesthesia techniques-infraorbital-infratrochlear nerve block (ION-ITN block) and transnasal sphenopalatine ganglion block (usg guided sphenopalatine ganglion block,SPG block)-in patients undergoing septorhinoplasty under general anesthesia. Eligible patients aged 18-65 years with ASA physical status I-II will be randomly assigned to one of two intervention groups. Blocks will be performed after induction by an anesthesiologist not involved in postoperative assessment. Patients, surgeons, anesthesiologists performing postoperative evaluations, follow-up investigators, and data analysts will remain blinded to group allocation.
Postoperative outcomes will include pain intensity assessed using the Numerical Rating Scale (NRS) at 0-2, 2-8, and 8-24 hours after surgery, agitation between extubation and PACU discharge assessed with the Riker Sedation-Agitation Scale (RSAS), emergence agitation (RSAS ≥5), time to first rescue analgesic, and total tramadol consumption within 24 hours. Additional outcomes include postoperative nausea and vomiting, cardiovascular and respiratory adverse events, surgical site complications (edema, hematoma, neurologic deficit), and patient satisfaction measured by a 5-point Likert scale. Preoperative demographics, BMI, ASA class, comorbidities, anesthesia and surgery duration, and intraoperative remifentanil consumption will be recorded. The study aims to determine whether SPG block provides superior postoperative analgesia compared with ION-ITN block in septorhinoplasty patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Infraorbital-Infratrochlear Nerve Block (ION-ITN Block) | Active Comparator | Infraorbital-Infratrochlear Nerve Block (ION-ITN Block) |
|
| Sphenopalatine Ganglion Block | Active Comparator | Transnasal Sphenopalatine Ganglion Block (SPG Block) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infraorbital-Infratrochlear Nerve Block | Procedure | Bilateral infraorbital and infratrochlear nerve block performed with 0.5% bupivacaine after induction of general anesthesia |
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| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Pain Intensity | Pain intensity assessed using the Numerical Rating Scale (NRS, 0-10) at three postoperative intervals: 0-2 hours, 2-8 hours, and 8-24 hours. Higher scores indicate greater pain. | 0-24 hours postoperative |
| Postoperative Agitation | Agitation severity assessed using the Riker Sedation-Agitation Scale (RSAS). The highest postoperative RSAS score is recorded. RSAS ≥5 is defined as emergence agitation. | Immediate postoperative period (from extubation to discharge from the post-anesthesia care unit [PACU]; up to 2 hours) |
| Measure | Description | Time Frame |
|---|---|---|
| Total Tramadol Consumption | Total amount of intravenous tramadol administered as postoperative analgesia. | First 24 hours postoperative |
| Incidence of Postoperative Nausea and Vomiting (PONV) | Occurrence of nausea or vomiting requiring treatment with ondansetron. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital | Diyarbakır | Turkey | 21070 | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40087987 | Background | Can E, Akkaya OT. A Comparison of Transnasal Versus Ultrasound-Guided Suprazygomatic Approaches for Sphenopalatine Ganglion Blocks in Persistent Idiopathic Facial Pain. Ann Indian Acad Neurol. 2025 Mar 1;28(2):189-195. doi: 10.4103/aian.aian_713_24. Epub 2025 Mar 13. |
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Two-arm, parallel-group, randomized and double-blind clinical trial comparing infraorbital-infratrochlear nerve block with transnasal sphenopalatine ganglion block in patients undergoing septorhinoplasty.
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Patients, surgeons, anesthesiologists assessing postoperative outcomes, follow-up investigators, and data analysts were all blinded to group allocation throughout the perioperative period.
| Transnasal Sphenopalatine Ganglion Block | Procedure | Transnasal sphenopalatine ganglion block performed after induction of general anesthesia using local anesthetic-soaked applicators |
|
| 0-24 hours postoperative |
| Adverse Events in PACU | Respiratory or cardiovascular events including oxygen desaturation, airway obstruction, hypotension, hypertension, or arrhythmia. | Immediate postoperative period (from extubation to discharge from the post-anesthesia care unit [PACU]; up to 2 hours) |
| Patient Satisfaction Score | Patient satisfaction assessed using a 5-point Likert scale (1 = very unsatisfied, 5 = very satisfied). | At 24 hours postoperative |