Clinical trial NCT04495868: Bacteriostatic Normal Saline Versus Lidocaine for Intradermal Anesthesia
Official title: Bacteriostatic Normal Saline Versus Lidocaine for Intradermal Anesthesia During Lumbar Medial Branch Block
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Pain
Keywords: Local anesthetic
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2020-08-03
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Needle Placement Pain Score
timeFrame: Day 1
Secondary outcomes:
measure: Skin Wheal Pain Score
timeFrame: Day 1
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Pain Clinic
state: Georgia
Study officials:
affiliation: Emory University
name: Brian Bobzien, MD
role: PRINCIPAL_INVESTIGATOR
References: