Bacteriostatic Normal Saline Versus Lidocaine for Intradermal Anesthesia During Lumbar Medial Branch Block
Phase: PHASE4
Conditions: Chronic Pain
Sponsor: Emory University

 
 
PROTOCOL TITLE: Bacteriostatic Normal Saline versus lidocaine for intradermal 
anesthesia during lumbar medial branch block 
 
NCT NUMBER: NCT04495868 
 
PROTOCOL DATE: June 6, 2020 
 

 PROTOCOL TITLE:   Bacteriostatic Normal Saline versus lidocaine for intradermal anesthesia 
during lumbar medial branch block.
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VERSION:  1.1 – 06/06/2020.
PROTOCOL TITLE:   Bacteriostatic Normal Saline versus lidocaine for intradermal anesthesia 
during lumbar medial branch block.
PRINCIPAL INVESTIGATOR:
Brian Bobzien, MD
Department of Anesthesiology
EXTERNAL (NON-EMORY) COLLABORATORS N/A ☐:                                                                   N/A) 
VERSION:  1.1 – 06/06/2020.
FUNDING SOURCE: Funding will be supplied internally from the Pain Medicine Fellowship 
academic funds. No grants or external funding has been obtained. .
REVISION HISTORY
Revision #
Version 
Date
Summary of Changes
1.0
04/14/2020
Initial protocol
1.1
06/06/2020
Changes requested by IRB

 PROTOCOL TITLE:   Bacteriostatic Normal Saline versus lidocaine for intradermal anesthesia 
during lumbar medial branch block.
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VERSION:  1.1 – 06/06/2020.
Table of Contents
1.0
Study Summary....................................................................................................................4
2.0
Objectives............................................................................................................................4
3.0
Background..........................................................................................................................4
4.0
Study Endpoints *................................................................................................................4
5.0
Study Intervention/Investigational Agent ...........................................................................4
6.0
Procedures Involved* ..........................................................................................................5
7.0
Data and Specimen Banking* N/A ☐...................................................................................6
8.0
Sharing of Results with Participants* ..................................................................................6
9.0
Study Timelines*..................................................................................................................7
10.0
Inclusion and Exclusion Criteria*.........................................................................................7
11.0
Vulnerable Populations* N/A ☐..........................................................................................7
12.0
Local Number of Participants ..............................................................................................8
13.0
Recruitment Methods..........................................................................................................8
14.0
Withdrawal of Participants*................................................................................................8
15.0
Risks to Participants*...........................................................................................................8
16.0
Potential Benefits to Participants*......................................................................................9
17.0
Data Management* and Confidentiality .............................................................................9
18.0
Provisions to Monitor the Data to Ensure the Safety of Participants*................................9
19.0
Provisions to Protect the Privacy Interests of Participants................................................10
20.0
Economic Burden to Participants ......................................................................................10
21.0
Consent Process.................................................................................................................10
22.0
Process to Document Consent in Writing..........................................................................13
23.0
Setting................................................................................................................................13
24.0
Resources Available...........................................................................................................14
25.0
Multi-Site Research when Emory is the Lead Site*N/A ☐.................................................14
26.0
References.........................................................................................................................15

 PROTOCOL TITLE:   Bacteriostatic Normal Saline versus lidocaine for intradermal anesthesia 
during lumbar medial branch block.
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1.0
Study Summary
Study Title
Bacteriostatic Normal Saline versus lidocaine for 
intradermal anesthesia during lumbar medial branch 
blocks
Study Design
Randomized, double blinded, comparative study
Primary Objective
To determine if intradermal administration of 
bacteriostatic normal saline is less painful than 1% 
lidocaine plain
Secondary Objective(s)
To determine if intradermal bacteriostatic normal 
saline provides a similar level of skin anesthesia 
compared to 1% lidocaine plain
Research 
Intervention(s)/Interactions
Creation of skin wheals during a chronic pain 
procedure, specifically lumbar medial branch blocks, 
and assessment of pain scores
Study Population
Chronic pain patients
Sample Size
40
Study Duration for 
individual participants
30 minutes
Study Specific 
Abbreviations/ Definitions 
BNS – Bacteriostatic normal saline
MBB – Medial branch block
NRS – Numeric rating scale
Funding Source (if any)
Internal funds from the Pain Medicine Fellowship, 
Department of Anesthesiology, Emory School of 
Medicine
2.0
Objectives
2.1
The aim of this study is to test whether intradermal bacteriostatic normal 
saline reduces procedure-related pain compared to lidocaine 1% plain in 
subjects with chronic axial low back pain.  Specifically, this study will 
compare the pain associated with creation of a skin wheal and the resulting 
level of anesthesia between the two medications during a lumbar medial 
branch block (MBB).
• Objective #1 – To compare the pain experienced with creation of 
a skin wheal with bacteriostatic normal saline versus 1% lidocaine 
plain.
• Objective #2 – To compare the pain experienced when placing a 
needle through the skin wheal created with bacteriostatic normal 
saline versus 1% lidocaine plain.

 PROTOCOL TITLE:   Bacteriostatic Normal Saline versus lidocaine for intradermal anesthesia 
during lumbar medial branch block.
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2.2
Hypotheses
• Hypothesis #1 – Injection of bacteriostatic normal saline (BNS) for 
skin wheal will show lower patient-reported pain scores on 
injection than that of 1% lidocaine.
• Hypothesis #2 – Injection of BNS for skin wheal anesthesia is non-
inferior to that of the injection of the standard of care, 1% 
lidocaine, during medial branch block procedure.
3.0
Background
3.1
Interventional pain procedures are performed to aid in the diagnosis and 
treatment of chronic pain.  Like any invasive procedure, they carry a risk of 
procedure-related pain that may affect the patient in a negative way.  
Temporary consequences include the heightened pain itself, anxiety, 
premature abortion of the procedure, increased heart rate and blood 
pressure, and vasovagal reactions.  Longer-term issues include aversion 
and/or anxiety to future procedures.  These procedures are performed in 
patients with chronic pain and they may experience a heightened level of 
pain compared to patients without chronic pain.  Also, it is often the case 
that creation of a skin wheal with local anesthetic is the most painful part 
of the procedure. [1]  Some clinicians have resorted to moderate sedation 
and even general anesthesia to help reduce procedure-related pain; 
however, recent guidelines have advised against this practice since it has 
been associated with negative outcomes. [2]
3.2
Lumbar medial branch blocks are a specific interventional pain procedure 
used to determine if chronic axial low back pain is originating from facet, or 
zygapophyseal joints.  Facet joints are innervated by medial branch nerves 
which arise from the dorsal ramus branch of spinal nerve roots.  The 
procedure entails blocking the corresponding medial branch nerves for a 
given facet joint with a small amount of local anesthetic.  If the patient has 
significant pain relief, there is a high likelihood that their pain is arising 
from the targeted joints. [3,4]  Because the procedure is diagnostic in 
nature, limiting the amount of local anesthetic injected is of paramount 
importance.  If other possible pain-generating structures are blocked with 
local anesthetic, it will make it impossible to determine which structure is 
causing pain.  Therefore, typically only a skin wheal is created to limit pain 
on needle insertion besides the local anesthetic injected at the medial 
branch nerve. It is also important to minimize intravenous sedation for the 
same reason. In addition to the consequences of increased procedure-
related pain stated above, increased pain during a medial branch block has 
been show to increase false-negative results. [5]

 PROTOCOL TITLE:   Bacteriostatic Normal Saline versus lidocaine for intradermal anesthesia 
during lumbar medial branch block.
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3.3
A number of factors have been identified that affect the pain from 
intradermal injections (injectate, pH, size of needle, angle of needle, 
attitude/words of proceduralist).[6]  Investigators have examined 
alternatives for a number of these factors including the addition of sodium 
bicarbonate[7] and smaller needle size[8].  Other studies have investigated 
alternatives to intradermal injections themselves including topical local 
anesthetics[9] and no local anesthetic at all[8,10].  Recently, a study was 
conducted that showed performing the medial branch block procedure 
without creating skin wheals may be less painful; however, the study used 
25 gauge needles where in many cases a larger 22-gauge needle is 
used.[10]  This study also re-demonstrated the painful nature of creating a 
skin wheal with lidocaine 1%.  
3.4
There has been a significant amount of research on a specific alternative to 
local anesthetics - bacteriostatic normal saline (BNS), which contains 0.9% 
benzyl alcohol.[7,11-15]  Benzyl alcohol is an opium alkaloid that is 
sometimes added to physiologic normal saline for its bacteriostatic 
properties.[11,16]  It has been shown to be safe[17] with one case report 
of allergic dermatitis[16].  The anesthetic properties of benzyl alcohol have 
been known since 1918[18] although its structure differs from other local 
anesthetics making it unlikely to cause an allergic reaction in patients with 
a local anesthetic allergy[19].
3.5
There are studies showing bacteriostatic normal saline to be less painful on 
injection and also providing the same level of anesthesia compared to 
lidocaine.[7,12-14]  However, to our knowledge, no studies have been 
conducted comparing BNS to lidocaine for interventional pain procedures 
in a chronic pain population.
4.0
Study Endpoints *
4.1
The primary study endpoint is the improvement in procedure-related 
discomfort during a lumbar MBB.
4.2
There are no safety-related endpoints. 
5.0
Study Intervention/Investigational Agent
5.1
The study intervention is the creation of a skin wheal (intradermal 
injection) with BNS and 1% lidocaine plain.
5.2
Drug/Device Handling:  The storage, handling, and blinding of the 
medications will be performed by Grady Pharmacy using their established 
protocol.  The administration of the medications (i.e. intradermal injection) 
will be performed by the principal investigator (PI).

 PROTOCOL TITLE:   Bacteriostatic Normal Saline versus lidocaine for intradermal anesthesia 
during lumbar medial branch block.
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6.0
Procedures Involved*
6.1
An individual’s participation will occur during a lumbar medial branch block 
procedure. All subjects will have qualified for a lumbar medial branch block 
due to axial low back pain with lumbar spondylosis as the primary 
diagnosis.  All subjects would have received lumbar medial branch blocks 
during their normal clinical course whether or not they choose to 
participate in this study
6.2
This study will focus solely on skin wheal creation and resulting skin 
anesthesia with lidocaine 1% and bacteriostatic saline. The lumbar medial 
branch block procedure typically requires two or more skin wheal 
injections prior to placement of the spinal needle that ultimately delivers 
the block.  Subjects will serve as their own control.  The first two skin 
wheals will be utilized for the study and the medications will be 
randomized with both the subject and investigator blinded to the 
medication used for each one.  The first two skin wheals and placement of 
the first two spinal needles through these skin wheals will be performed by 
the principal investigator to promote consistency.
6.3
Using a standardized script, the participant will be informed that the 
medication will be administered.  The skin wheal will be created by 
injecting the medication intra-dermally with a 26 gauge needle. The patient 
will be asked to rate on the numerical rating scale (NRS) the pain 
experienced with creation of the skin wheal.  This process will then be 
repeated with the second skin wheal.  Next, the first needle for the block 
will be inserted through the first skin wheal. The patient will again be asked 
to rate, on the NRS, the pain of needle insertion.  For this procedure, a 22 
gauge Quincke spinal needle will be used with a length of either 3.5 or 5 
inches.  This process will again be repeated by inserting the second needle 
through the second skin wheal. 
6.4
At this point, the individual’s participation in the research study is complete 
and the lumbar medial branch block will be continued as usual with any 
subsequent skin wheals created with 1% lidocaine plain (standard of care, 
not study related). The remainder of the medial branch block (after the 
conclusion of the individual’s participation in the study) may be performed 
by the pain fellow or the principal investigator (attending).
6.5
Basic demographics (age, gender) and baseline pain score will be collected 
directly from the participant by the investigator before the intervention.  
During and after the intervention, the levels (L2, L3, L4, etc) and laterality 
injected and pain scores from the intervention will be collected directly 
from the subject by the investigator.  No identifiable PHI will be collected 
or stored.
7.0
Data and Specimen Banking* N/A ☐

 PROTOCOL TITLE:   Bacteriostatic Normal Saline versus lidocaine for intradermal anesthesia 
during lumbar medial branch block.
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N/A
8.0
Sharing of Results with Participants*
8.1
This study does not involve any testing (diagnostic, genetic, imaging, etc.) 
that may generate potentially shareable results.
9.0
Study Timelines*
9.1
The duration of an individual participant’s participation is approximately 
thirty (30) minutes.  We anticipate the duration of enrollment to be 
approximately four (4) months assuming an average of three to four (3-4) 
lumbar medial branch blocks scheduled per week based on past procedure 
volumes. We anticipate an additional one (1) month for data analysis.
10.0
Inclusion and Exclusion Criteria*
10.1 When the patient arrives for the scheduled lumbar medial branch block, 
the subject will be consented for the procedure.  After consenting for the 
procedure, one of the investigators will screen the patient for eligibility in 
the study.
10.2 Inclusion criteria – any patient scheduled for an initial lumbar medial 
branch block
10.3 Exclusion criteria
• Allergy to local anesthetics
• Fibromyalgia
• Inability to provide informed consent in English
10.4 We will also exclude the following special populations:
•
Adults unable to consent
•
Individuals who are not yet adults (infants, children, teenagers)
•
Pregnant women
•
Prisoners
10.5
Community Participation:  N/A  
11.0
Vulnerable Populations* N/A ☐
N/A
12.0
Local Number of Participants

 PROTOCOL TITLE:   Bacteriostatic Normal Saline versus lidocaine for intradermal anesthesia 
during lumbar medial branch block.
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12.1 Based on the power analysis, the total number of participants will be forty 
(40).  We will plan to screen fifty (50) subjects assuming some may not 
consent to the study or may be excluded based on the exclusion criteria.  
Since the lumbar medial branch block is rarely performed in patients with a 
local anesthetic allergy or fibromyalgia, we expect the excluded subjects to 
be quite low.
13.0
Recruitment Methods
13.1 Potential participants will be asked to participate after he/she has 
consented to the lumbar medial branch block procedure.
13.2 Participants come from the patient population at the Grady Pain Clinic.
13.3 Any patient that is planning to undergo a lumbar medial branch block is a 
potential participant.
13.4 There will not be any recruitment materials since only patients undergoing 
lumbar medial branch blocks are potential participants which is a small 
subset of the patient population at the Grady Pain Clinic.
13.5 There will be no payments for participation or reimbursement for 
expenses/travel since the overall procedure is part of the subject’s usual 
medical care
14.0
Withdrawal of Participants*
14.1 If a participant choses to not undergo the procedure after consenting but 
before creation of the first skin wheal, the participant will be withdrawn 
from the research.
14.2 If a participant choses to abort the procedure after creating of the first skin 
wheal, the procedure will be immediately stopped.  While this participant 
will not count to our goal of forty (40) participants, the data will be 
analyzed to identify if there is a pattern regarding subjects that abort the 
procedure (i.e. is the creation of the skin wheal too painful or does not 
supply an adequate level of anesthesia for the spinal needle).
15.0
Risks to Participants*
15.1 It is foreseeable that the participant may experience pain/discomfort with 
the creation of the skin wheal or placement of the spinal needle through 
the skin wheal created by BNS.  Since creation of a skin wheal with 1% 
lidocaine plain is standard of care, pain/discomfort occurring from this is 
unfortunately expected and unavoidable and the basis of performing this 
research to identify better options.  The probability that the participant will 
experience significantly more pain/discomfort from BNS is very low given 
the results of prior studies.  Any pain/discomfort experienced related to 
the skin wheal will be of a very short duration (seconds).

 PROTOCOL TITLE:   Bacteriostatic Normal Saline versus lidocaine for intradermal anesthesia 
during lumbar medial branch block.
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15.2 The participant may experience an allergic reaction to the medications 
however this is also extremely low.  
15.3 Given the short duration of the medications administered, there are no 
risks to an embryo or fetus should the subject become pregnant after the 
study.  Subjects currently pregnant are excluded.
16.0
Potential Benefits to Participants*
16.1 A potential benefit includes less pain with injection of BNS; however, the 
magnitude of this benefit is low since only one skin wheal will be created 
with BNS.  The rest will be created with 1% lidocaine plain.
17.0
Data Management* and Confidentiality
17.1
Data will be analyzed using SAS 9.4 (Cary, NC) by the Anesthesiology 
Department’s Biostatistician. For the first hypothesis, a General Linear Model will 
be applied, which is equivalent to a modified matched-pairs t-test, but allows for 
inclusion of potential confounders, such as the injection order. If assumptions of 
the General Linear Model are not met, e.g. the data are too leptokurtic or too 
positively skewed, then another statistical test such as Ordinal Logistic 
Regression will be used instead. For the second hypothesis, a non-inferiority test 
will be conducted, calculating delta as the maximum value for the 90% 
confidence interval, with an effect size of 0.24, an alpha set at 0.1, and a 
standard deviation of the difference determined from the sample data.
17.2
Power analysis was conducted with G*Power 3.1.9.4 (Düsseldorf, 
Germany). [20] A two-tailed a priori difference between two dependent means 
(matched pairs) was conducted. Alpha (Type I error) was set at 0.05 and power 
was set at 0.80. An effect size was set at 0.46, which is the mean effect size of a 
meta-analysis, [15] and is lower than the effect size of 0.52 calculated for a 
similar study. [11] This yielded a minimum required sample size of N=40.
17.3
Guidelines provided by the Grady/Emory Data and Safety Monitoring 
Board will be followed for this study data. Envelopes with random assignment of 
subjects to treatment arms will be in a locked filing folder and stored at the 
Grady Pain clinic office.  No names, MRNs, or other personal identifiers will be 
used for the subjects - they will be given a random number identifier. Data 
results of subject’s VAS scores will be immediately loaded to an encrypted and 
password protected Excel file and/or RedCap. The principal and secondary 
investigators will have access to the locked office/filing folder.  If any reportable 
events are identified, they will be reported to the IRB as required by 
regulations.  All study records will be reviewed at least annually. 
17.4 Data results of subject’s NRS scores will be immediately loaded to an 
encrypted and password protected Excel file and/or RedCap.   The data will 
include the randomly assigned number identifier of the subject and the 
result of their NRS score.  Data will be stored for 3 years.  Only Brian 

 PROTOCOL TITLE:   Bacteriostatic Normal Saline versus lidocaine for intradermal anesthesia 
during lumbar medial branch block.
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Bobzien, MD (PI) will have access to the data, and he is responsible for the 
receipt and transmission of the data.
18.0
Provisions to Monitor the Data to Ensure the Safety of Participants*
18.1 Due to the nature of the study using products that are currently 
commercially available and FDA approved for injection, it is unlikely that 
there would be major untoward events that are novel. The most likely 
possible event would be an unexpected allergic reaction to either lidocaine 
1% or bacteriostatic saline, which would be identified at the time of the 
procedure. The secondary safety data being reviewed would be patient’s 
ability to tolerate injection of or needle insertion with both the lidocaine 
1% and bacteriostatic saline. During the study, the safety data will be 
monitored by the fellow on rotation at Grady along with Dr. Bobzien (PI). 
The fellow on rotation will monitor safety data via case report forms 
completed on each procedure detailing the procedure and any 
complications. Safety data collection will be a continuous process via case 
report forms starting at the beginning of data collection. Safety data will be 
reviewed on a monthly basis by the fellow on their Grady rotation. If either 
a high rate of unexpected allergic reactions or inability of patients to 
tolerate injection of or needle insertion with both the lidocaine 1% and 
bacteriostatic saline is identified then this would trigger suspension of the 
research. Efficacy data will be reviewed on a quarterly basis by the six 
fellows and Dr. Bobzien (PI).
19.0
Provisions to Protect the Privacy Interests of Participants
19.1 Patients will only be interacting with providers who would otherwise be 
participating in their care regardless of participation in the study. 
Participation in the study will not introduce any additional persons 
interacting with the patients.
19.2 The questions being asked will be standardized and will only be evaluating 
a patient’s level of pain during an examination or procedure they would 
otherwise be receiving regardless of their participation in the study. No 
additional examinations or procedures will be asked of the patient’s that 
they would not otherwise receive due to their diagnosis or plan of care.
19.3 The research team, consisting of the current pain fellows and Dr. Bobzien 
(PI), will access patient information via the Epic EEMR system at Grady 
Memorial Hospital. No information other than that would otherwise be 
available in order to routinely treat patients will be made available.
20.0
Economic Burden to Participants
20.1 Participants will not incur any costs related to participation in this study.

 PROTOCOL TITLE:   Bacteriostatic Normal Saline versus lidocaine for intradermal anesthesia 
during lumbar medial branch block.
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21.0
Consent Process
21.1
Consent will be obtained from participants in person the day of the 
procedure. This will be performed in an exam room prior to taking the patient to 
the procedure room.  Consent will be obtained by an investigator.  All 
researchers will be educated on the patients and procedure that this study is 
applicable towards in order to ensure the consistent consenting process of 
applicable patients. No waiver for any elements of the consent or HIPAA 
authorization will be needed. The therapeutic/diagnostic procedure performed 
on the patient will be unchanged, only the solution injected for skin 
topicalization will be randomized therefore no changes to the procedure consent 
form must be made.  No vulnerable groups (children, prisoners, pregnant 
women, cognitive impairment, and employees) will be included in the study.  The 
risk of coercion or undue influence in enrolling patients in this study is low.  
However all individuals obtaining consent will be educated on ethical practice 
and the voluntary nature of patient participation in this research study. 
Comprehension of the informed consent will be ensured by providing both 
verbal and written detailed information to the patient. The patient will also be 
asked if they have any questions, and if so ample time will be allowed for 
clarification.
Non-English-Speaking Participants N/A ☐   N/A
Participants who are not yet adults (infants, children, teenagers) N/A ☐   N/A
Cognitively Impaired Adults N/A ☐  N/A
Adults Unable to Consent N/A ☐  N/A
22.0
Process to Document Consent in Writing
22.1 Consent will be documented in writing by having the participant sign the 
consent document.  A copy will be provided to the participant and the 
original document will be stored in a locked cabinet in a locked office in the 
clinic.
22.2 Consent document attached. 
23.0
Setting
23.1 The research study will be conducted at the Grady Pain Clinic which is 
located on the first floor of Grady Memorial Hospital in area 1A.  
Identification, screening, consent, and procedures will all be conducted in 
this clinic. 
24.0
Resources Available

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during lumbar medial branch block.
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24.1 The Grady Pain Clinic is located on the first floor (1A) of Grady Memorial 
Hospital.  It has 4 exam rooms, 1 procedure/fluoroscopy room, and 1 
recovery room.  There is one LPN at this time with positions for one RN and 
one CMA outstanding.  The clinic sees over 300 patients a month with the 
majority of those patients having chronic low back pain.  A lumbar medial 
branch block is a diagnostic/prognostic procedure performed to identify 
back pain from lumbar facet joints and likely response to radiofrequency 
ablation of the medial branch nerves.  From examining past procedure 
volume, this procedure is performed three to four (3-4) times a week on 
average.  We anticipate fifty (50) potential participants over the four (4) 
months window and expect enrollment of 80% or forty (40) participants. 
24.2 This research is being performed as part of the Pain Medicine Fellowship 
research/quality improvement project.  The principal investigator, Dr. Brian 
Bobzien, MD, is Director of the Grady Pain Clinic and works full-time at the 
clinic.  Pain Medicine fellows rotate through the clinic on a monthly basis 
and will participate in research study as co-investigators.  We anticipate an 
additional thirty (30) minutes to complete the screening, consent, and 
study intervention.  The principal investigator will devote four to five (4-5) 
hours per week to conducting and completing the research. 
24.3 The nursing staff will be informed about the protocol prior to initiating 
enrollment; however, nursing staff will not be directly involved in aspects 
of the research, just the investigators.  The co-investigators meet on a 
monthly basis currently and will continue until the study is completed. 
24.4 As mentioned earlier, the risk of pain/discomfort with this research study 
will be short-lived.  In the event of an allergic reaction, although unlikely, 
the patient will be managed supportively in the Pain Clinic similarly to any 
other patient that may experience an allergic reaction during a procedure 
and will be referred to the Grady’s Allergy clinic.  If the patient reports 
psychological issues related to their participation in this study, the patient 
will be referred to Grady’s mental health department at 10 Park Place.
25.0
Multi-Site Research when Emory is the Lead Site*N/A ☐ 
25.1
N/A
26.0 References
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during lumbar medial branch block.
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