Sinusitis. Chronic sinusitis
Conditions
Interventions
Intervention 1: Intervention group: Intervention: Infiltration of the pterygopalatine fossa with a solution of lidocaine and adrenaline (commercially known as Carpol) prior to endoscopic sinus surgery
Sponsors
Shiraz University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: The study will include patients aged ?? years and older who are scheduled to undergo functional endoscopic sinus surgery (FESS) due to chronic sinusitis with bilateral nasal polyps, as confirmed by computed tomography (CT) scans of the paranasal sinuses.
Exclusion criteria
Exclusion criteria: • Unilateral disease (the symmetry of the disease will be assessed using the Lund-Mackay grading system based on preoperative CT scans (?)).• Systemic corticosteroid uses within four weeks prior to surgery.• Untreated or poorly controlled hypertension.• Bleeding disorders.• Hypersensitivity to lidocaine and epinephrine.• Use of aspirin, anticoagulants, or herbal medications within four weeks prior to surgery.• Pregnant or lactating individuals.• Patients with systemic diseases affecting the nasal region.• Deformities of the skull or face.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome, intraoperative bleeding, will be measured continuously during the surgical procedure. Bleeding will be assessed every 15 minutes using the Boezaart scale for each surgical side, with the total blood loss recorded separately for each side at the end of surgery. No additional measurements are planned after the completion of the operation. Timepoint: Each 15 minutes. Method of measurement: Intraoperative bleeding will be measured using the Boezaart and van der Merwe scale every 15 minutes for each surgical side. Total blood loss will be quantified in milliliters by collecting all suctioned fluids and surgical materials separately for each side. Postoperative fluids will also be collected and included in the total blood loss calculation. Blood pressure and pulse will be recorded alongside the bleeding score to monitor hemodynamic stability. The injection side will be compared to the contralateral control side.;Surgical field visibility will be assessed using the standard Boezaart and van der Merwe scale, scored every 15 minutes by the surgeon. Heart rate, mean arterial blood pressure, and end-tidal CO2 (ETCO2) will be recorded intraoperatively by the anesthesiologist. Duration of surgery for each side will be documented. Postoperative Assessment: Secondary nasal bleeding will be checked using tetracycline-soaked nasal packs. All patients will receive cephalexin 500 mg four times daily for 7 days postoperatively. Fluticasone propionate nasal spray (twice daily per nostril) will be recommended for 12 weeks, along with regular nasal irrigation using normal saline. Timepoint: Intraoperative: Surgical field visibility, heart rate, mean arterial pressure, and ETCO2 will be recorded every 15 minutes during surgery. Surgical sides will alternate every 30 minutes. Duration of surgery will be recorded for each side.Postoperative: Secondary nasal bleeding will be assessed daily using tetracycline-soaked nasal packs. Cephalexin will be administered for 7 days, | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactReza Kaboodkhani
Shiraz University of Medical Sciences
Outcome results
None listed