Viewing Study NCT04583137



Ignite Creation Date: 2024-05-06 @ 3:17 PM
Last Modification Date: 2024-10-26 @ 1:46 PM
Study NCT ID: NCT04583137
Status: UNKNOWN
Last Update Posted: 2020-10-12
First Post: 2020-10-05

Brief Title: Buffered vs Plain Lidocaine for Local Nasal Anesthesia
Sponsor: Kfir Siag
Organization: HaEmek Medical Center Israel

Study Overview

Official Title: Buffered vs Plain Lidocaine for Local Nasal Anesthesia
Status: UNKNOWN
Status Verified Date: 2020-10
Last Known Status: NOT_YET_RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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 preference12

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 anesthesia3 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 dentistry4

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

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: False
Is an FDA AA801 Violation?: None