Clinical trial NCT04583137: Buffered vs Plain Lidocaine for Local Nasal Anesthesia
Official title: Buffered vs Plain Lidocaine for Local Nasal Anesthesia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Anesthesia, Local
Keywords: Nasal Sprays, Lidocaine, Bicarbonate, Local anesthesia
Lead sponsor: HaEmek Medical Center, Israel
Sponsor class: OTHER
First posted: 2020-10-12
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: DIAGNOSTIC

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.

Detailed description: 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.

Products containing lidocaine are used in everyday practice, sometimes combined with vasoconstrictors such as oxymetazoline or phenylephrine. Lidocaine does not require special storage conditions and is a relatively inexpensive product.

Besides its use for local nasal anesthesia, lidocaine is also widely used for local and regional anesthesia in dentistry, emergency medicine, and surgical or invasive procedures. The addition of bicarbonate for lowering the acidity level of the solution has been studied before in these applications. The buffered solution demonstrated decreased patients pain and increased patient preference\[1,2\].

Solutions containing lidocaine with a vasoconstrictor such as epinephrine are widely used for soft tissue injection. This combination allows the benefits of prolonged anesthetic and decreased bleeding of the surgical site. However, this combination disadvantage includes increased acidity of the solutions, which may cause increased pain or burning sensation during drug administration. Alkalinization of combined lidocaine and epinephrine solutions has shown decreased local site pain, shorter onset time, and longer duration of anesthesia\[3\]. The addition of bicarbonate may be done by mixing into a syringe or other suitable container in a relatively easy and fast application for clinical use. Alternatively, a designated device may be used, such as the Onpharma mixing system (Onpharma), commonly used in dentistry\[4\].

While the alkalinization of lidocaine had shown advantages in local injection into soft tissues, its efficacy for local nasal anesthesia was not previously examined.

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

Eligibility 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.

Primary outcomes:
measure: VAS- Visual Analogue Scale
timeFrame: Immediately after the procedure
measure: First symptoms questionnaire
timeFrame: Immediately after the procedure
measure: Second symptoms questionnaire
timeFrame: one hour after TFL exam
measure: Third questionnaire
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Afula
country: Israel
facility: HaEmek Medical Center
Study officials:
affiliation: Emek Medical Center, Afula, Israel.
name: Kfir Kfir, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.