Buffered vs Plain Lidocaine for Local Nasal Anesthesia

NCT04583137 | Unknown Early Phase 1

• 1 other identifier: EMC-20-0185
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anesthesia, Local

Keywords

Nasal Sprays, Lidocaine, Bicarbonate, Local anesthesia

Outcome Measures

Primary Outcomes (4)

• VAS- Visual Analogue Scale

  pain assessment from TFL on a 0-100 visual scale

  Immediately after the procedure

• First symptoms questionnaire

  pain or burning sensation from local anesthetic administration, bitter or unpleasant taste, suffocation or foreign body sensation of throat, dyspnea, cough, difficulty swallowing saliva, nausea, headache, numbness of mouth and lips, general discomfort during the procedure, patient willingness to go through the procedure again if medically relevant, patient willingness to recommend this procedure to another person if medically relevant. All answers are filled on a 0 to 10 scale, with ten being the most severe.

  Immediately after the procedure

• Second symptoms questionnaire

  suffocation or foreign body sensation of throat, dyspnea, cough, difficulty swallowing saliva, nausea, headache, numbness of mouth and lips, general discomfort during the procedure, patient willingness to go through the procedure again if medically relevant, patient willingness to recommend this procedure to another person if medically relevant. All answers are filled on a 0 to 10 scale, with ten being the most severe. Duration until symptoms had passed 0-15, 15-30, 30-45, 45-60, 60 minutes or more.

  one hour after TFL exam

• Third questionnaire

  The third questionnaire is filled during a follow-up telephone interview. The patient is asked if there was any epistaxis, syncope, or any other adverse event during the one-month follow-up period.

  one month

Study Arms (2)

Buffered lidocaine

EXPERIMENTAL

Each participant receives a single intranasal application of atomized 1 mL lidocaine 5% solution combined with bicarbonate 8.4% in a 1:10 ratio.

Drug: Lidocain

Plain lidocaine

EXPERIMENTAL

Each participant receives a single intranasal application of atomized 1 mL lidocaine 5% solution.

Drug: Lidocain

Interventions

Lidocain DRUG

Layngeal direct fiberoptic examination transnasaly

Also known as: Transnasal fiberoptic larnyngoscopy

Buffered lidocaine; Plain lidocaine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing TFL exam as part of their medical investigation and treatment.
• Age above 18 years and under 65 years.
• Both sexes

You may not qualify if:

• 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).

Sponsors & Collaborators

• Kfir Siag: lead

Study Sites (1)

HaEmek Medical Center

Afula, 1834111, Israel

Location

Related Publications (5)

• Cepeda MS, Tzortzopoulou A, Thackrey M, Hudcova J, Arora Gandhi P, Schumann R. Adjusting the pH of lidocaine for reducing pain on injection. Cochrane Database Syst Rev. 2010 Dec 8;(12):CD006581. doi: 10.1002/14651858.CD006581.pub2.

  PMID: 21154371 BACKGROUND

• Lee HJ, Cho YJ, Gong HS, Rhee SH, Park HS, Baek GH. The effect of buffered lidocaine in local anesthesia: a prospective, randomized, double-blind study. J Hand Surg Am. 2013 May;38(5):971-5. doi: 10.1016/j.jhsa.2013.02.016. Epub 2013 Apr 6.

  PMID: 23566722 BACKGROUND

• Gupta S, Kumar A, Sharma AK, Purohit J, Narula JS. "Sodium bicarbonate": an adjunct to painless palatal anesthesia. Oral Maxillofac Surg. 2018 Dec;22(4):451-455. doi: 10.1007/s10006-018-0730-x. Epub 2018 Oct 15.

  PMID: 30324508 BACKGROUND

• Goodchild JH, Donaldson M. Novel Direct Injection Chairside Buffering Technique for Local Anesthetic Use in Dentistry. Compend Contin Educ Dent. 2019 Jul/Aug;40(7):e1-e10.

  PMID: 31478693 BACKGROUND

• Nakayama M, Munemura Y, Kanaya N, Tsuchida H, Namiki A. Efficacy of alkalinized lidocaine for reducing pain on intravenous and epidural catheterization. J Anesth. 2001;15(4):201-3. doi: 10.1007/s005400170003.

  PMID: 14569436 BACKGROUND

Study Officials

• Kfir Kfir, MD

  Emek Medical Center, Afula, Israel.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kfir Siag, MD

CONTACT

+97246495530; kfir.siagMD@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Both solutions will be kept in identical syringes with an atomization tip (Teflex, MAD Nasal™ Intranasal Mucosal Atomization Device). Each product has a randomized serial number. Both the investigator and the participant are masked. The solutions are made by a different investigator who is not part of the clinical examination, questionnaire filling, patients selection, and recruitment.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr, Kfir Siag; Principal Investigator; Department of Otolaryngology-Head and neck surgery

Model Details: trial containing two groups. The first group receives an intranasal solution of lidocaine combined with bicarbonate. The second group receives intranasal plain lidocaine. After a measured time of 5 minutes, all patients will attend a TFL examination. The patients will fill the first questionnaire immediately after the procedure, a second questionnaire by telephone after one hour, and the third questionnaire by telephone after a one-month follow-up. Sample size was calculated using data from a previous publication of local soft tissue injection with buffered lidocaine5. This estimation power analysis showed that for VAS average and standard deviation were 3.5±1.4 for the lidocaine group and 2.5±1.4 for the second group given lidocaine with bicarbonate. In order to achieve a statistical power of 90% and significance of p\<0.05 a sample of 40 patients is needed for each group, 80 patients in total. The comparison will be made using Mann-Whitney U-test.

Study Record Dates

• First Submitted: October 5, 2020
• First Posted: October 12, 2020
• Study Start: November 1, 2020
• Primary Completion: November 1, 2022
• Study Completion: March 1, 2023
• Last Updated: October 12, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)