Buffered vs Plain Lidocaine for Local Nasal Anesthesia

• Status: Not yet recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

Summary

Transnasal Fiberoptic Laryngoscopy (TFL) is a common procedure in the otolaryngology clinic for the examination of vocal cord appearance and function, inspection and follow up of benign and malignant lesions, and investigating foreign body ingestion.

There are many forms for applying preprocedural local nasal anesthesia such as atomizers, nebulizers, spray, soaked pads, or local anesthetic gel application.

This study compares the effect of buffered versus plain lidocaine for local nasal anesthesia.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kfir Siag
• Treatments: Lidocaine

Criteria

Inclusion Criteria:

• Patients undergoing TFL exam as part of their medical investigation and treatment.

• Age above 18 years and under 65 years.

• Both sexes

Exclusion Criteria:

• Age under 18 years or above 65 years.

• Hypersensitivity to the experiment drugs- bicarbonate, lidocaine, or another drug from the Amid type local anesthetics group (such as Emla or bupivacaine).

• Pregnancy or lactation.

• Signs and symptoms of recent URTI (rhinitis, cough, fever, sinusitis, tonsillitis, pharyngitis).

• Recurrent epistaxis - once per year or more.

• Cardiovascular conditions- ischemic heart disease with decreased physical functions of climbing two staircases or walking 500 meters on a horizontal plane without difficulty. Arrhythmias including permanent or paroxysmal atrial fibrillation, or using a pacemaker.

• Dysphagia- difficulty with swallowing, recurrent aspirations or pneumonia, decreased sensation that may affect swallowing such as previous CVA, peripheral neuropathy from any reason including diabetes. Partial or complete vocal cord immobility.

• Previous TFL exam once in the past six months or twice in the past year.

• Anxiety disorder - with or without drug therapy.

• Recurrent syncope for any reason, including vasovagal syncope. Epilepsy or recurrent seizures.

• Nose and sinuses disease- chronic sinusitis, recurrent sinusitis four or more events per year, Surgical intervention of nose or sinuses in the past year including submucous resection of the septum, turbinectomy, or endoscopic sinus surgery.

• Daily use of a nasal spray of any kind- including steroids or vasoconstrictors.

• Oncologic patients- undergoing chemotherapy or radiation, known tumor in the present or past of the nose and sinuses, nasopharynx, pharynx, hypopharynx, larynx, or subglottis. Patients after resections in these areas or after radiation to head, neck, or chest.

• Severe kidney impairment- GFR under 30 mL/min or severe liver impairment.

• Systemic disease involving the upper airways (e.g. pemphigus).

• Immunosuppression- HIV, drug-induced or congenital

• Unable to give informed consent for any reason, including unable to read or understand the consent form, being under psychiatric assessment, or taking psychiatric drugs.

• Current therapy with known interaction to the experimental drugs- cimetidine, propranolol, phenytoin.

• Moderate to severe nasal polyposis.