Chronic PainPhase 4NCT04495868
Bacteriostatic Normal Saline Versus Lidocaine for Intradermal Anesthesia
A Phase 4 study testing Bacteriostatic Normal Saline and 1% Lidocaine in people with Chronic Pain, run by Emory University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain
- What is being tested?
- Bacteriostatic Normal Saline and 1% Lidocaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jan 2021to 6 Apr 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for an initial lumbar medial branch block
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Bacteriostatic Normal Saline Versus Lidocaine for Intradermal Anesthesia During Lumbar Medial Branch Block
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.
Read the 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.
- Conditions
- Chronic Pain
- Being tested
- Bacteriostatic Normal Saline, 1% Lidocaine
- Keywords
- Local anesthetic
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bacteriostatic Normal SalineDrug
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% LidocaineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Bacteriostatic Normal Saline; Drug: 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. Receives: Drug: Bacteriostatic Normal Saline; Drug: 1% Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Secondary outcomes (1)
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2020
- Study start8 Jan 2021
- Primary completion6 Apr 2022
- Study completion6 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic PainStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Bobzien, Emory University
- Investigators
- Brian Bobzien, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04495868
- Sponsor's protocol ID
- STUDY00000428
- Status last verified
- Mar 2023
- First submitted
- 29 Jul 2020
- Last updated
- 18 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data collected during the trial will be available for sharing, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bacteriostatic Normal Saline Versus Lidocaine for Intradermal Anesthesia During Lumbar Medial Branch Block
- ClinicalTrials.gov ID
- NCT04495868
- Acronym / sponsor ID
- STUDY00000428
- Conditions
- Chronic Pain
- Keywords
- Local anesthetic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 8 Jan 2021 (actual)
- Primary completion
- 6 Apr 2022 (actual)
- Study completion
- 6 Apr 2022 (actual)
- First posted
- 3 Aug 2020 (actual)
- Results
- Posted 18 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bacteriostatic Normal Saline then 1% Lidocaine | Experimental | Drug: Bacteriostatic Normal Saline, Drug: 1% LidocaineParticipants 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 | Drug: Bacteriostatic Normal Saline, Drug: 1% LidocaineParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients scheduled for an initial lumbar medial branch block
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bacteriostatic Normal SalineA 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. | Drug | 1% Lidocaine then Bacteriostatic Normal Saline, Bacteriostatic Normal Saline then 1% Lidocaine |
| 1% LidocaineA 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. | Drug | 1% Lidocaine then Bacteriostatic Normal Saline, Bacteriostatic Normal Saline then 1% Lidocaine |
Primary outcome
Needle Placement Pain Score
Time frame: 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.
1 secondary outcome
Skin Wheal Pain Score
Time frame: Day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Individual participant data collected during the trial will be available for sharing, after deidentification.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Brian Bobzien, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bacteriostatic Normal Saline and 1% Lidocaine in people with Chronic Pain, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 18 Apr 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Needle Placement Pain Score (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023; AzTrials last refreshed its copy on 6 Nov 2026.