Bacteriostatic Normal Saline Versus Lidocaine for Intradermal Anesthesia

Chronic Pain Clinical Trial

Official title:

Bacteriostatic Normal Saline Versus Lidocaine for Intradermal Anesthesia During Lumbar Medial Branch Block

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04495868
• Other study ID #: STUDY00000428
• Status: Completed
• Phase: Phase 4
• Start date: January 8, 2021
• Est. completion date: April 6, 2022

Study information

• Verified date: March 2023
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 6, 2022
• Est. primary completion date: April 6, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients scheduled for an initial lumbar medial branch block

Exclusion Criteria:

• Allergy to local anesthetics

• Fibromyalgia

• Inability to provide informed consent in English

• Adults unable to consent

• Individuals who are not yet adults (infants, children, teenagers)

• Pregnant women

• Prisoners

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Drug:
• Bacteriostatic Normal Saline
A skin wheal will be made with bacteriostatic normal saline (BNS). BNS contains 0.9% benzyl alcohol and benzyl alcohol is an opium alkaloid that is sometimes added to physiologic normal saline for its bacteriostatic properties. The skin wheal will be created by injecting the medication intra-dermally with a 26 gauge needle.
• 1% Lidocaine
A skin wheal will be made with 1% lidocaine. The skin wheal will be created by injecting the medication intra-dermally with a 26 gauge needle.

Locations

Country	Name	City	State
United States	Grady Pain Clinic	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Needle Placement Pain Score	Participants rated their pain level from the insertion of the needle for the lumbar medial branch block using the skin wheal created with each anesthetic. Pain is rated on a scale from 0 to 10, where 0 = no pain and 10 = worst pain.	Day 1
Secondary	Skin Wheal Pain Score	Participants rated their pain level from the creation of the skin wheal using each anesthetic on a scale from 0 to 10, where 0 = no pain and 10 = worst pain.	Day 1