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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bacteriostatic Normal Saline then 1% Lidocaine | Experimental | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bacteriostatic Normal Saline | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Bobzien, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grady Pain Clinic | Atlanta | Georgia | 30303 | United States |
Individual participant data collected during the trial will be available for sharing, after deidentification.
Data will be available for sharing beginning immediately upon publication and ending 36 months following article publication.
Data will be available for sharing with researchers who provide a methodologically sound proposal, in order to achieve the aims in the approved proposal. Proposals should be directed to bbobzie@emory.edu. A link will be provided to the researcher for download of the data.
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| ID | Title | Description |
|---|---|---|
| FG000 | Bacteriostatic Normal Saline Then 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: 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. |
| FG001 | 1% Lidocaine Then 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: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Bacteriostatic Normal Saline Then 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. |
| BG001 | 1% Lidocaine Then Bacteriostatic Normal Saline |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Median | Inter-Quartile Range | units on a scale | Day 1 |
|
Information on adverse events was collected during the lumbar medial branch block procedure (Day 1 of study).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Bacteriostatic Normal Saline | Participants undergoing a lumbar medial branch block receiving an intradermal administration of bacteriostatic normal saline. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brian Bobzien, MD | Emory University | 404-616-4226 | brian.patrick.bobzien@emory.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jun 6, 2020 | Mar 25, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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|
| 1% Lidocaine | Drug | 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. |
|
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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Numerical Pain Rating Scale (NPRS) Score of Back Pain | The NPRS is an 11-point, self-rated pain scale where participants rate the level of their chronic axial low back pain from 0 (no pain) to 10 (worst pain imaginable). | Median | Inter-Quartile Range | units on a scale |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 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. | Posted | Median | Inter-Quartile Range | units on a scale | Day 1 |
|
|
|
| 0 |
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
| EG001 | 1% Lidocaine | Participants undergoing a lumbar medial branch block receiving an intradermal administration of 1% lidocaine. | 0 | 40 | 0 | 40 | 0 | 40 |
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| Aniline Compounds |
| D000588 | Amines |