Nasal Septum Deviation, NSD
Conditions
Interventions
treatment group:Apply 0.5 units (approximately 5g) of the compound chamomile lidocaine gel evenly to the outer surface of one expanded sponge. Insert one expanded sponge into each nostril.
control group:A blank gel containing no active pharmaceutical ingredients is uniformly applied to the outer surface of one piece of dilated sponge. All other procedures are identical to those performe
Sponsors
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing university Medical School
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Age 18–65 years, no gender restriction; 2. Diagnosed with nasal septum deviation (with or without inferior turbinate hypertrophy) confirmed by nasal endoscopy and imaging, planning to undergo septoplasty (± inferior turbinate surgery); 3. Meet the surgical indications for septoplasty: (1) Nasal septum deviation causing nasal obstruction affecting normal respiratory function; (2) Nasal septum deviation causing reflex headaches; (3) Nasal septum deviation obstructing sinus drainage, leading to chronic sinusitis; (4) Anterior septal deviation causing recurrent epistaxis; 4. American Society of Anesthesiologists (ASA) physical status classification I–II; 5. Voluntarily participate in this study, able to understand the contents of the informed consent, and sign the written informed consent; 6. Good compliance and able to complete follow-up according to the study protocol.
Exclusion criteria
Exclusion criteria: 1. Patients with acute nasal cavity infection or inflammation: those with acute infections in the nasal cavity or sinuses (acute rhinitis, acute sinusitis), or uncontrolled inflammation on the face or nasal vestibule (boils, cellulitis); 2. Patients with lesions in the nasal cavity: untreated nasal tumors or malignant lesions, foreign bodies in the nasal cavity, or severe mucosal lesions; 3. History of nasal surgery or nasal trauma; 4. Allergic to the study drug components (chamomile extract, lidocaine, or other ingredients), or known allergy to local anesthetics; 5. With severe systemic diseases (heart failure NYHA >= III, severe liver or kidney dysfunction, hematologic diseases, etc.); 6. Coagulation disorders (INR > 1.5, platelets < 80 x 10^9/L) or long-term use of anticoagulants; 7. Participation in other clinical studies within the past 30 days; 8. Judged by the investigator to be unsuitable for participation in this study for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The VAS score for nasal pain 6 hours after the operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Inflammatory biomarkers IL-6 and IL-1ß in nasal secretions: Changes in their levels before and after medication administration;The SNOT-22 score (nasal cavity and paranasal sinuses outcome assessment) of the patient before and after medication administration;The DIP scores of the patient before and after medication (evaluating nasal secretions, inflammation, polyps/edema); | — |
Countries
China
Contacts
Public ContactQian xiaoyun
Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing university Medical School
Outcome results
None listed