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Nasal turbinectomy surgeries are usually done as day case surgeries as most patients are young with unremarkable comorbidities. However, considerations are still present towards patients of old age or those suffering from obesity or obstructive sleep apnea (OSA). Different techniques are still evolving to improve handling those patients to decrease complications, enhance recovery after surgery and increase patient satisfaction. Targeting sphenopalatine ganglion block by topical local anesthesia is a proposed technique that could help by decreasing peri-operative opioid consumption.
Patients undergoing turbinectomy usually suffer from chronic nasal congestion with wide spectrum of symptoms ranging from headache and breathing difficulty to sleep disorders and obstructive sleep apnea that could affect daily life .
Usually the surgery is done as a day case surgery in patients without major comorbidities. Points of concern to achieve smooth outcome and enhance recovery include pain management, better surgical field for both patient and surgeon satisfaction. One approach for these goals include regional nerve blocks for the innervation of the nose .
Spheno Palatine Ganglion (SPG) block was tested with a good results for blocking autonomic innervation and subsequent decrease in pain and opioid consumption. Blockage of SPG has many approaches either trans nasal or trans oral but both are invasive and needs trained hands to do Locally infiltrating lidocaine over nasal mucosa either by lidocaine spray or a lidocaine soaked gauze was also tested in nasal surgeries with good results but doubts about duration of action of lidocaine spray is a concern that may affect post-operative pain management Targeting SPG noninvasively by lidocaine spray is proposed technique that may offer easier approach for this type of surgeries. Although concerns about effectiveness of the spray to reach and block SPG was raised before , many studies examined this approach to control headache or trigeminal neuralgia with great success.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| balanced anaesthesia | Active Comparator | Patients will receive standardized general anaesthesia: fentanyl 2 mcg/kg actual body weight (ABW) at induction, propofol 1.5 mg/kg, rocuronium 0.6 mg/kg, and sevoflurane 1 MAC for maintenance. After intubation and bilateral application of xylometazoline nasal decongestant drops, morphine 0.05 mg/kg ABW will be administered intravenously. All patients will additionally receive paracetamol 1g IV and ketorolac 30 mg IV in 100 mL normal saline intraoperatively. Intraoperative rescue analgesia: fentanyl 50 mcg IV will be administered in response to tachycardia (heart rate exceeding 20% above individual baseline) or hypertension (systolic blood pressure exceeding 20% above individual baseline). The rescue dose will be repeated after 10 minutes if the haemodynamic response criterion persists. Postoperatively pethidine 50 mg IV will be administered for VAS score greater than 4. Regular paracetamol 1g IV will be given every 8 hours for up to 24 hours postoperatively or until discharge. |
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| Lidocaine spray | Experimental | Patients will receive identical standardized general anaesthesia as Group A. After intubation and bilateral application of xylometazoline nasal decongestant drops, intranasal lidocaine 10% spray will be applied bilaterally 10 puffs per nostril by directing the spray applicator parallel to the nasal floor in a postero-superior direction until resistance is felt, targeting the region of the sphenopalatine fossa. Total lidocaine dose will be verified not to exceed 3 mg/kg ABW. All patients will additionally receive paracetamol 1g IV and ketorolac 30 mg IV in 100 mL normal saline intraoperatively. Intraoperative rescue analgesia and postoperative managment as group A. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Balanced anesthesia | Drug | Standardized general anaesthesia with fentanyl 2 mcg/kg ABW at induction, propofol 1.5 mg/kg, rocuronium 0.6 mg/kg, sevoflurane 1 MAC for maintenance, followed by morphine 0.05 mg/kg ABW after intubation and nasal decongestant application. Intraoperative rescue fentanyl 50 mcg IV for tachycardia or hypertension exceeding 20% above baseline, repeatable after 10 minutes. Postoperative paracetamol 1g IV every 8 hours and pethidine 50 mg IV for VAS greater than 4. |
| Measure | Description | Time Frame |
|---|---|---|
| Fentanyl doses | Total cumulative intraoperative fentanyl rescue dose (mcg) administered in response to tachycardia defined as heart rate exceeding 20% above individual baseline or hypertension defined as systolic blood pressure exceeding 20% above individual baseline, given in increments of 50 mcg intravenously and repeatable every 10 minutes if the triggering criterion persists. | Intraoperative |
| Measure | Description | Time Frame |
|---|---|---|
| Visual analog Score | Postoperative pain intensity will be assessed using the Visual Analogue Scale for Pain (VAS-Pain), a unidimensional 10-point numerical scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain; higher scores indicate worse pain outcome. VAS-Pain will be assessed at four prespecified timepoints: recovery room arrival, 2 hours, 6 hours, and 12 hours postoperatively, by a blinded outcomes assessor. Rescue analgesia with pethidine 50 mg intravenously will be administered for VAS-Pain score greater than 4. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain shams university hospitals | Cairo | Egypt |
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| ID | Term |
|---|---|
| D058126 | Balanced Anesthesia |
| ID | Term |
|---|---|
| D000768 | Anesthesia, General |
| D000758 | Anesthesia |
| D000760 | Anesthesia and Analgesia |
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A two-anesthesiologist model will be employed to achieve investigator blinding. Anesthesiologist 1 (unblinded) will open the sealed randomization envelope and administer the allocated intervention after induction and nasal decongestant application, then withdraw from all further patient care and data recording for that case. Anesthesiologist 2 (blinded) will assume full intraoperative management after intervention administration is complete, recording all vital signs, haemodynamic events, and rescue analgesic doses without knowledge of group allocation. A third anesthesiologist (Anesthesiologist 3, blinded) with no involvement in intraoperative care will conduct all postoperative assessments including VAS-Pain scoring, pethidine administration, and recovery timing from recovery room arrival to 12 hours postoperatively. Patient blinding is ensured by administering all group-specific interventions after induction of general anaesthesia and loss of consciousness. The operating surgeon is
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| Lidocaine spray | Drug | Identical general anaesthesia induction and maintenance as the control arm. After intubation and bilateral xylometazoline nasal decongestant: intranasal lidocaine 10% spray 10 puffs per nostril bilaterally, directed parallel to the nasal floor in a postero-superior direction until resistance is felt, targeting the sphenopalatine fossa. Total dose not to exceed 3 mg/kg ABW. Identical rescue and postoperative analgesia as control arm. |
|
| Up to 12 hours post operative |
| Intraoperative Tachycardia | Number of patients experiencing at least one episode of heart rate exceeding 20% above individual baseline intraoperative heart rate, recorded by continuous ECG monitoring with non-invasive readings documented every 5 minutes from T0 to end of surgery | Intraoperative |
| Intraoperative Hypertension | Number of patients experiencing at least one episode of systolic blood pressure exceeding 20% above individual baseline systolic blood pressure, recorded by non-invasive blood pressure monitoring every 5 minutes from T0 to end of surgery | Intraoperative |
| Total Postoperative Pethidine | Cumulative dose of pethidine in milligrams administered intravenously in response to Visual Analogue Scale score greater than 4, recorded from recovery room arrival to 12 hours postoperatively by a blinded outcomes assessor | Up to 12 hours postoperative |
| Time to Extubation | Time in minutes from end of surgery to successful tracheal extubation, assessed by the blinded outcomes assessor | Immediate postoperative period |
| Time to Aldrete Score ≥9 | Time in minutes from tracheal extubation to attainment of a modified Aldrete score of 9 or above, indicating readiness for discharge from the post-anaesthesia care unit, assessed by the blinded outcomes assessor | Immediate postoperative period |