Bacteriostatic Normal Saline Versus Lidocaine for Intradermal Anesthesia

Status Completed

Clinical Trial Summary

The purpose of this study is to determine if creation of a skin wheel with bacteriostatic normal saline, which includes 0.9% benzyl alcohol, is less painful and provides a similar level of anesthesia compared to 1% lidocaine. Participants will receive both types of anesthesia, in random order.

Clinical Trial Description

Most chronic pain procedures or injections utilize medications (e.g. local anesthetics) to numb the skin in an effort to reduce procedure-related pain; however, they can also be a significant cause of pain leading the patient to abort the procedure. Studies have looked at alternative medications and techniques that lessen the pain but still provide similar levels of anesthesia ("numbing"). One such alternative medication is normal saline that includes benzyl alcohol. Studies researching this specific medication have usually examined procedural pain related to drawing blood or placing an intravenous (IV) catheter but not for chronic pain related procedures. This is a single site randomized double-blinded clinical trial that will compare the standard of care (1% lidocaine) with bacteriostatic normal saline (saline with benzyl alcohol) administered as a skin wheal during a diagnostic procedure in patients with chronic low back pain. The order of administration of the medication will be randomized and the medication will be blinded to both the subject and the investigator performing the procedure. Skin wheals will be created with each medication, and the subject's level of pain will be assessed after each one to measure how painful the creation of the skin wheal was. Then, a spinal needle for the diagnostic procedure will be placed through the skin wheal and the subject's level of pain will be assessed after each one to measure the level of anesthesia (or numbing) that each one provides. The objectives of this study are to determine if administration of bacteriostatic normal saline causes less discomfort than 1% lidocaine and provides a similar level of anesthesia/numbing for the procedure. The study will take place at the Grady Pain clinic and participants will be identified from patients that are scheduled to undergo a specific low back procedure - diagnostic lumbar medial branch block. This research study will help identify potential alternatives to the standard of care for numbing of skin during chronic pain procedures that may reduce procedure-related pain and discomfort thus making the procedure more tolerable. ;

Study Design

Related Conditions & MeSH terms

Chronic Pain

Clinical Trial Details

NCT number	NCT04495868
Study type	Interventional
Source	Emory University
Contact
Status	Completed
Phase	Phase 4
Start date	January 8, 2021
Completion date	April 6, 2022

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.