Intranasal 10% Lidocaine Spray Versus Intravenous Morphine During Partial Turbinectomy (SPG block)
Intranasal 10% Lidocaine Spray Versus Intravenous Morphine During Partial Turbinectomy: a Randomized Controlled Trial
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.
Přehled studie
Postavení
Postavení
Podmínky
Podmínky
Intervence / Léčba
Intervence / Léčba
Detailní popis
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.
Typ studie
Typ studie
Zápis (Aktuální)
Zápis
Fáze
Fáze
- Fáze 3
Kontakty a umístění
Studijní místa
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Cairo, Egypt
- Ain shams university hospitals
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Kritéria účasti
Kritéria způsobilosti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
Inclusion Criteria:
- Undergoing elective partial turbinectomy surgery
- Age 18 years or older
Exclusion Criteria:
- Patient refusal
- Kidney or liver impairment
- Pregnant or breast-feeding women
- Allergy to any of the drugs used in the study
- OR time more than 90 minutes (defined as time after anaesthesia induction and securing Endotracheal tube to end of surgery, excluding extubation time)
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Prevence
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Trojnásobný
Počet zbraní
Zbraně a zásahy
Skupina účastníků / ArmSkupina účastníků / Arm |
Intervence / LéčbaIntervence / Léčba |
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Aktivní komparátor: balanced anaesthesia
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. |
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. |
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Experimentální: Lidocaine spray
Patients receive the same standardized induction and maintenance of general anaesthesia as the active comparator arm (fentanyl 2 mcg/kg ABW, propofol 1.5 mg/kg, rocuronium 0.6 mg/kg, sevoflurane 1 MAC), but no intravenous morphine; intranasal lidocaine spray replaces the morphine given in the active comparator arm. 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. |
Identical general anaesthesia induction and maintenance as the control arm, without intravenous morphine. 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. |
Co je měření studie?
Primární výstupní opatření
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Fentanyl doses
Časové okno: Intraoperative
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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
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Sekundární výstupní opatření
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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Visual analog Score
Časové okno: Up to 12 hours post operative
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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. |
Up to 12 hours post operative
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Intraoperative Tachycardia
Časové okno: Intraoperative
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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
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Intraoperative Hypertension
Časové okno: Intraoperative
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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
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Total Postoperative Pethidine
Časové okno: Up to 12 hours postoperative
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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
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Time to Extubation
Časové okno: Immediate postoperative period
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Time in minutes from end of surgery to successful tracheal extubation, assessed by the blinded outcomes assessor |
Immediate postoperative period
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Time to Aldrete Score ≥9
Časové okno: Immediate postoperative period
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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
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Spolupracovníci a vyšetřovatelé
Sponzor
Sponzor
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Začátek studia
Primární dokončení (Aktuální)
Primární dokončení
Dokončení studie (Aktuální)
Dokončení studie
Termíny zápisu do studia
První předloženo
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
První zveřejněno
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Poslední zveřejněná aktualizace
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
Další identifikační čísla studie
- FMASU R239/2025
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