Bacteriostatic Normal Saline Versus Lidocaine for Intradermal Anesthesia

Phase 4

Completed

• Conditions: Chronic Pain
• Interventions: Drug: Bacteriostatic Normal Saline; Drug: 1% Lidocaine

• Registration Number: NCT04495868
• Lead Sponsor: Emory University

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2020-07-29
• Study First Submitted QC: 2020-07-29
• Study First Posted: 2020-08-03
• Study Start: 2021-01-08
• Primary Completion: 2022-04-06
• Study Completion: 2022-04-06
• Status Verified: 2023-03
• Results First Submitted: 2023-03-28
• Results First Submitted QC: 2023-03-28
• Last Update Submitted: 2023-03-28
• Results First Posted: 2023-04-18
• Last Update Posted: 2023-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients scheduled for an initial lumbar medial branch block

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1% Lidocaine then Bacteriostatic Normal Saline	Bacteriostatic Normal Saline	Participants undergoing a lumbar medial branch block who are randomized to receive an intradermal administration of 1% lidocaine followed by an intradermal administration of bacteriostatic normal saline.
Bacteriostatic Normal Saline then 1% Lidocaine	1% Lidocaine	Participants undergoing a lumbar medial branch block who are randomized to receive an intradermal administration of bacteriostatic normal saline followed by an intradermal administration of 1% lidocaine.
Bacteriostatic Normal Saline then 1% Lidocaine	Bacteriostatic Normal Saline	Participants undergoing a lumbar medial branch block who are randomized to receive an intradermal administration of bacteriostatic normal saline followed by an intradermal administration of 1% lidocaine.
1% Lidocaine then Bacteriostatic Normal Saline	1% Lidocaine	Participants undergoing a lumbar medial branch block who are randomized to receive an intradermal administration of 1% lidocaine followed by an intradermal administration of bacteriostatic normal saline.

Primary Outcome Measures

Name	Time	Method
Needle Placement Pain Score	Day 1	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.

Secondary Outcome Measures

Name	Time	Method
Skin Wheal Pain Score	Day 1	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.

Trial Locations

Locations (1)

Grady Pain Clinic; 🇺🇸 Atlanta, Georgia, United States