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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Plain lidocaine | Experimental | Each participant receives a single intranasal application of atomized 1 mL lidocaine 5% solution. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocain | Drug | Layngeal direct fiberoptic examination transnasaly |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kfir Siag, MD | Contact | +97246495530 | kfir.siagMD@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Kfir Kfir, MD | Emek Medical Center, Afula, Israel. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| HaEmek Medical Center | Afula | 1834111 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21154371 | Background | 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. | |
| 23566722 | 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. |
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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.
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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.
| 30324508 | 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. |
| 31478693 | 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. |
| 14569436 | 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. |