Do Cervical Interlaminar Epidural Steroid Injections With Low-dose Lidocaine Cause Transient Objective Upper Extremity Weakness? A Prospective Randomized Controlled Trial
Phase: PHASE4
Conditions: Cervical Radiculitis, Pain
Sponsor: Northwestern University

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PROTOCOL TITLE:  Do Cervical Interlaminar Epidural Steroid Injections with Low-dose 
Lidocaine Cause Transient Objective Upper Extremity Weakness? A Prospective 
Randomized Controlled Trial 
 
 
PRINCIPAL INVESTIGATOR: 
David Walega, M.D. 
Department of Anesthesiology 
(312) 695-2500 
d-walega@northwestern.edu 
 
 
VERSION NUMBER: 1.3 
 
 
VERSION DATE:  05/17/2019 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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OBJECTIVES: 
 
1.0 Research Aims: 
 
1.   Research Question:  
Is there a detectable difference upper extremity strength as measured with 
dynamometry after cervical epidural steroid injections when lidocaine is used instead of 
saline as a steroid diluent in patients with cervical radiculitis?  
 
2.   Null Hypothesis: 
There is no difference in upper extremity strength when lidocaine is used as a steroid 
diluent instead of saline for cervical epidural steroid injections.  
 
BACKGROUND: 
Literature:  
Cervical radicular pain is a common problem that is often treated by epidural steroid 
injection (1). While clinical practice guidelines do not specifically recommend or 
discourage the use of local anesthetic in the epidural injectate (2), the majority of the 
published literature on clinical outcomes of cervical epidural steroid injection includes 
the use of lidocaine in the epidural injectate (3-11). Consequently, many practitioners 
elect to use local anesthetic in the epidural injectate in order to provide immediate pain 
relief to patients in cases of exquisitely painful radicular symptoms. Local anesthetic 
may also be used in such cases to gain additional clinical information regarding a 
patient’s analgesic response, which may help pinpoint a precise anatomic source of 
pain when the clinical presentation and pain generator is not clear.  
 
Local anesthetic injection into the epidural space has the potential to cause transient 
weakness of the upper extremities. High doses of local anesthetic in the cervical 
epidural space (12) and inappropriately placed low-dose local anesthetic in the subdural 
space or subarachnoid space (13,14) are known to cause motor weakness. 
Appropriately placed, low-dose local anesthetic injected into the epidural space via a 
transforaminal approach, in close proximity to the exiting spinal nerve root, causes 
motor block in a small proportion of patients (15). However, the effect of low-dose 
injection of local anesthetic in the cervical interlaminar epidural space on objective 
upper extremity strength has not been well characterized in the published literature. 
This proposition affects post-procedure instructions, as even mild weakness may pose a 
hazard during performance manual activities that require the upper extremity/extremities 
such as using a handrail or cane handle for support.   
 
Dynamometry is an established method for assessing muscle strength and motor 
neuron function with high reliability, and has been used to objectively assess changes in 
upper extremity strength and has been validated in several patient populations (16-22). 
 

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This study aims to determine whether a standard dose of 2 mL 1% lidocaine vs 2mL of 
saline included as a steroid diluent in a C7-T1 cervical interlaminar epidural steroid 
injection (CESI) causes an objective change in strength as measured by dynamometry.  
 
We hypothesize that CESI with lidocaine will cause an objective transient decrease in 
upper extremity strength, consistent with the expected duration of this local anesthetic. 
 
Significance: Cervical radiculitis is a relatively common pain syndrome and is often 
treated with cervical epidural steroid injection (CESI) when conservative treatments 
(oral analgesics, physical therapy and activity modification for example) have failed to 
provide relief of symptoms. There are no universal clinical practice guidelines for the 
use of or type of diluents when CESI are performed.  
Interlaminar CESI may be performed with or without the use of local anesthetics. CESI 
without the benefit of local anesthetic as a steroid diluent will not provide immediate 
relief of pain in patients with excruciating radicular symptoms, and also limits clinical 
information gleaned from the immediate analgesic response. Finally, the lack of 
immediate pain relief following spine interventions for chronic pain management may 
decrease patient satisfaction (23).  
 
By evaluating the effects of local anesthetic as a diluent during interlaminar CESI, we 
will provide information about the potential for objective motor weakness with this 
commonly performed pain management procedure.  
 
INCLUSION AND EXCLUSION CRITERIA: 
Patients who plan to undergo CESI for treatment of cervical radiculitis or the control 
group (no CESI) will be screened for eligibility by authorized research personnel during 
their visit to the Northwestern Anesthesiology Pain Medicine Center, 259 E. Erie, Suite 
1400, Lavin Pavilion. 
 
CESI Group 
Inclusion criteria: 
All patients ages 18 years or older who will undergo CESI for treatment of cervical 
radiculitis.  
 
Exclusion criteria: 
Subject refusal  
Subject unwilling to provide written consent  
History of a hypersensitivity to amide local anesthetics 
Any medical contraindication to CESI  
Inability of the subject to communicate in English with research personnel  
Inability of the subject to perform handgrip or arm strength testing 
Cervical spinal cord lesions 
Cerebrovascular, demyelinating or other neuromuscular muscular disease 
Subject request for or requirement of intravenous conscious sedation for the injection 
procedure 

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Pregnancy 
Breast feeding 
 
Non CESI Group (control) 
Inclusion Criteria: 
All patients ages 18 years or older who will undergo trigger point injections (TPI) 
TPI include: Occipital facet or cervical facet injection 
 
Exclusion Criteria: 
Subject refusal 
Subject unwilling to provide written consent  
Pregnant 
Breastfeeding 
History of a hypersensitivity to amide local anesthetics 
Inability of the subject to communicate in English with research personnel  
Inability of the subject to perform handgrip or arm strength testing 
Cervical spinal cord lesions 
Cerebrovascular, demyelinating or other neuromuscular muscular disease 
 
 
STUDY-WIDE NUMBER OF PARTICIPANTS: 
 Sample Size Calculation 
  
 Group 1: n = 60 (CESI with Lidocaine Diluent) 
 Group 2: n = 60 (CESI with Saline Diluent) 
  Group 3: n = 20 (no CESI, control group)  
 
A power analysis was performed based upon previous observations of changes in UE 
strength (24,25) using Fisher’s Exact Test. Sample sizes of 52 in each of the two 
treatment groups will achieve > 80% power to detect a group different in proportions, 
assuming 20% of patients in the Lidocaine group will demonstrate a motor deficit after 
the CESI and those in the Saline group will demonstrate no difference in motor strength 
after the CESI, and further assuming a 2% measurement error with the strength testing 
method described.  The alpha level of this test statistic is set at 0.05, but the 
significance level actually achieved by this study design is 0.0004. To allow for drop 
outs, a total of 130 subjects will be enrolled in group 1 and 2. Group 3 will enroll a 
convenience sample of 20 control subjects based on available patients. Total of 150 
subjects for the study will be enrolled.  
 
Statistical analysis: The primary outcome (UE strength by dynamometry will be 
compared between the lidocaine and control group using Fisher’s Exact Test. 
Secondary outcomes will be compared using the Mann-Whitney test for continuous data 
and a chi-squared statistic.  A P <0.05 will be required to reject the null hypothesis. 
 
 
STUDY-WIDE RECRUITMENT METHODS: N/A 
 

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MULTI-SITE RESEARCH: N/A 
 
STUDY TIMELINES: 
Each enrolled subject will receive a follow up telephone call 24 hours and one week 
after the procedure. The anticipated duration for study enrollment is 6 months. 
 
STUDY ENDPOINTS: 
Primary outcome: 
Change in upper extremity strength defined by dynamometry measurements for each 
individual in each treatment group before and 30 minutes after the procedure (CESI or 
no CESI).  
 
Secondary outcomes: 
Mean arterial pressure  
Heart rate  
Numeric Rating Scale (NRS) pain score  
Upper Extremity Functional Index (UEFI) score  
Procedure complications  
 
PROCEDURES INVOLVED: 
Study design: 
 
Prospective, randomized, controlled, double blinded trial in patients undergoing CESI 
for symptoms of cervical radiculitis. 
 
Group #1:  Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL 
1% lidocaine (total volume 4 cc). 
 
Group #2:  Interlaminar cervical ESI at the C7-T1 level with triamcinolone 80 mg + 2 mL 
preservative saline (total volume 4 cc).  
 
Group #3:  Control group (No CESI) cervical or occipital facet injection 
 
Adults who are eligible to have a CESI for treatment of cervical radiculitis at the 
Northwestern Anesthesiology Pain Medicine Center will be approached by authorized 
research personnel prior to a patient’s CESI is performed and will obtain informed 
consent from patients who agree to participate.  
 
A pre-procedure NRS pain score and presence of subjective or objective symptoms of 
UE weakness will be recorded by a blinded authorized study team member. Bilateral 
handgrip, wrist extension, elbow flexion, and elbow extension strength (myotomes C5-
T1) will be measured prior to the injection procedure using a handheld JAMAR® PLUS+ 
digital dynamometer (Sammons Preston, Bolingbrook, IL) for hand grip strength and a 
push/pull handheld hydraulic dynamometer (Balego and Associates Inc., St. Paul, MN) 
for arm strength assessment.  Three baseline strength measurements will be recorded 
for each strength test. Measurements will be taken prior to and 30 minutes following the 

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injection procedure. Participants will also be queried with the Upper Extremity 
Functional Index (UEFI) before the injection procedure and again 1 day and 1 week 
after the procedure (administered via telephone).  
 
Group 1 and 2 participants will be randomized to treatment group based on a random 
computer-generated schedule (https://www.randomizer.org) and will be blinded to the 
group to which they are assigned. Blinding will not occur with Group 3.  Providers will 
not be blinded to randomization; blinded research personnel will collect all outcome 
measures in this study. 
 
All standard Pain Center procedures for CESIs will be followed (standard practice) 
including time out, skin prep, hemodynamic monitoring, image guidance, post-injection 
instruction etc.  
 
Group 1 and Group 2 group  randomization, triamcinolone acetonide 80 mg (Kenalog, 
E. R. Squibb & Sons Limited, Uxbridge UK) will be combined with 2mL Lidocaine 1% or 
2 mL preservative free saline and will be injected during the CESI procedure. In all 
cases, the total injectate volume will be 4 mL. All injections will be performed with 
fluoroscopy guidance (current standard practice).  
 
Group 3 will receive standard treatment intramuscular injection of bupivacaine .25% 10-
20 mL and methylprednisolone 20 mg.  
 
All  participant’s will be recovered for approximately 20 minutes following the procedure 
( and will be discharged from the clinic with standardized written discharge instructions 
given to all patients who receive an injection in this practice (includes bathing 
instructions, activity following the procedure, signs and symptoms of neurologic 
compromise, for example). 
 
All participants will contacted by telephone  by authorized study team member on Day 2 
and again 1 week after the procedure (CESI or No CESI) to assess for residual 
subjective weakness in the hands or arms as well as any other adverse reactions. As 
the clinical duration of effect for 1% lidocaine is 1-2 hours in most patients, we do not 
expect to see sustained subjective weakness at 24 hour and 1 week post-CESI 
assessments as a result of this diluent. As above, the Upper Extremity Functional Index 
will be administered. 
 
Group 1 and 2 participants will only be recruited for this study for a single CESI.  Those 
who require repeat injections will not be recruited for this study a second or third time.  
 
 
DATA AND SPECIMEN BANKING: N/A 
 
DATA AND SPECIMEN MANAGEMENT: 
 

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The data will be collected by the research study team. Subject data will be stored in the 
Northwestern University REDcap data collection system accessible only by using a 
secured password protected departmental computer at Northwestern University 
Department of Anesthesiology Pain Center, Lavin Pavilion 14th floor.  
 
Data are backed up every night using Northwestern University Department of 
Anesthesiology (NM) servers which are stored on the 5th floor Arkes Pavilion and only 
accessible by the departmental IT administrator using key card and hard key as well as 
passwords. 
 
Completed paper data collection forms will be stored in locked cabinets in the office of 
the principal investigator on the 14th floor Lavin Pavilion, Department of Anesthesiology.  
Only study team members will have access to review the data. 
 
Each study subject will be assigned a study code number. The code will be used to link 
study data to participant identification (name) in a separate database and this will be 
kept in a dedicated Department of Anesthesiology password-protected computer in a 
locked office located on the 10 floor of Arkes Pavilion, Department of Anesthesiology 
offices. 
 
Strict measures will be in place to ensure that no loss of confidentiality occurs. Only 
study team members will have access to the data. The principal investigator will be 
oversee the handling and management of the data. 
 
Data both electronic and paper will be destroyed 5 years after manuscript preparation 
using current department protocol and current vendor. 
 
PROVISIONS TO MONITOR THE DATA TO ENSURE THE SAFETY OF 
PARTICIPANTS: 
 
The data collected will be periodically evaluated by a data monitoring committee 
consisting of the Department of Anesthesiology Director of Research, the Statistician 
and the Pain Center Medical Director regarding both harms and benefits to determine 
whether participants remain safe.   
Safety data and adverse event data will reviewed.  
- The frequency of data collection, including when safety data collection starts. 
Safety data collection occurs when completing the data collection form and 
reviewing the side effect profile of study drug.  
- 
Data will be reviewed by the research study team and the data monitoring 
committee.  
- 
The data will be reviewed every 15 subjects or if one of the study subjects 
experience a rapid response team intervention and review.  
- The statistical tests for analyzing the safety data to determine whether harm is 
occurring. Adverse events are rare with CESI. Therefore, the analysis for harm 
would be a simple assessment of the number and types of adverse events in this 
small study, if they are to occur.  

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WITHDRAWAL OF PARTICIPANTS: 
If the PI has determined that it is in the best interest of the subject, the PI will discuss 
the reason for withdrawal from the study with the subject. Data collected to that point 
will be included in the data analysis.  
 
RISKS TO PARTICIPANTS: 
Group 1 and 2 
Risks of study participation are the same as those for any fluoroscopically guided 
cervical ESI performed for management of cervical radiculitis when more conservative 
methods have been exhausted or failed. The duration of recovery for study participants 
is no longer than that of a standard CESI performed in this practice. 
 
Procedure risks:  
Localized infection 
Epidural hematoma or abscess 
Dural puncture and potential post-dural puncture headache  
Paresthesia during needle placement 
Pain at the injection side 
Failure of technique to decrease pain levels  
Allergy to latex, chlorhexidine, adhesives or any medications used during the procedure   
 
Risks of Triamcinolone acetonide 80 mg total dose (Kenalog 40 mg/mL) 
Common (less than 10%) 
Aggression 
Agitation 
Anxiety 
Blurred vision 
Decrease in the amount of urine  
Dizziness 
Fast, slow, pounding, or irregular heartbeat or pulse 
Headache 
Irritability 
Mental depression  
Mood changes 
Nervousness 
Noisy, rattling breathing 
Numbness or tingling in the arms or legs 
Pounding in the ears 
Shortness of breath 
Swelling of the fingers, hands, feet, or lower legs 
Trouble thinking, speaking, or walking 
Troubled breathing at rest 
Weight gain 
 
Incidence rate unknown: 

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Abdominal cramping and/or burning (severe), abdominal pain, backache, bloody, black, 
or tarry stools, cough or hoarseness, darkening of skin, decreased vision, diarrhea, dry 
mouth, eye pain   eye tearing, facial hair growth in females, fainting, fatigue, fever or 
chills, flushed, dry skin, fractures, fruit-like breath odor, full or round face, neck, or trunk, 
heartburn and/or indigestion (severe and continuous), increased hunger, increased 
thirst, increased urination, loss of appetite,  loss of sexual desire or ability, lower back or 
side pain, menstrual irregularities, muscle pain or tenderness, muscle wasting or 
weakness, nausea, pain in back, ribs, arms, or legs, painful or difficult urination, skin 
rash, sleeplessness, sweating, trouble healing, trouble sleeping,  unexplained weight 
loss, unusual tiredness or weakness, vision changes, vomiting, vomiting of material that 
looks like coffee grounds 
 
Risks of 1% Lidocaine  
Common (less than 10%): 
Hypotension 
Hypertension 
Nausea 
Vomiting 
Paresthesia 
Dizziness 
Bradycardia (slowed heart rate) 
 
Less Common (less than 5%): 
Convulsions 
Paresthesia  
Circumoral numbness 
Hyperacusis 
Visual disturbances 
Tremor 
Tinnitus 
Dysarthria 
CNS depression  
 
Rare (less than 1%): 
Cardiac arrest 
Cardiac arrhythmias 
Allergic reactions 
Anaphylactic reaction/shock 
Respiratory depression 
Neuropathy 
Diplopia 
 
Group 3: 
 
Risks of study participation are the same as those for any trigger point injections 
performed for pain management.  

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Localized infection 
Epidural hematoma or abscess 
Pain at the injection side 
 
There is the potential for loss of confidentiality even though there are strict measures in 
place to prevent occurrence. There is the potential for feeling uncomfortable completing 
the testing and questionnaires. There is the potential for feeling uncomfortable 
answering the follow up questions. 
 
POTENTIAL BENEFITS TO PARTICIPANTS: 
There are no direct benefits to the individual by participating in this study. The patients 
will be presented with the same treatment options whether they enroll in the study or 
decide not to participate. 
 
The information gained from this study may provide the investigators a better 
understanding of a patient’s pain and strength response following a cervical epidural 
steroid injection.     
 
SHARING OF RESULTS WITH PARTICIPANTS: 
After the study is completed and the randomization schedule becomes known to the 
research study team, if requested, we will notify the patient by telephone of the study 
group he or she belonged to. 
 
SETTING: 
Potential participants will be recruited for the study in the Northwestern Anesthesiology 
Pain Medicine Center, 259 E. Erie, Suite 1400 (Lavin Pavilion). The research study 
team member will review the consent document with the subject on the day of the 
procedure. 
 
The study drug will be administered during the procedure in the treatment area  
of the Pain Center. Study drugs are obtained from a password protected Omnicell 
machine in the Pain Center. Post procedure care will take place in the Pain Center 
recovery room. 
 
RESOURCES AVAILABLE: 
The research study team will be fully informed about the research protocol. Copies of 
the protocol with be available for review in the Pain Center. After enrollment, the study 
will be conducted in Pain Center. Research study team will collect procedure and post 
procedure data. The follow up will be by telephone at 24 hours and again 1 week 
following the procedure (CESI and Non CESI). 
 
PRIOR APPROVALS:  
This protocol has been reviewed and approved by the Department of Anesthesiology 
Research Committee 
 

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RECRUITMENT METHODS: 
Patients will be seen in the Pain Center, with a diagnosis of cervical radicular pain and 
scheduled to undergo CESI (Group 1 and 2) or no CESI (Group3) procedure by 
Anesthesiology Pain Center personnel will be recruited. If the subject meets the 
inclusion criteria and is interested to participate, the subject will be given a copy of the 
consent form to read on paper or on the Department of Anesthesiology Research 
password protected encrypted tablet. Research study team members will be present to 
answer all study related questions, after which the patient will sign the HIPAA compliant 
electronic consent form in REDcap.  
 
NUMBER OF LOCAL PARTICIPANTS: 
  Size of study groups:  
 Group 1: n = 60 
 Group 2: n = 60 
  Group 3: n = 20  
 
CONFIDENTIALITY: 
Data will be stored in a Northwestern University Department of Anesthesiology 
dedicated computers which are only accessible to the research study team. The 
computers are password protected and are located on the 10th floor Arkes Pavilion 
Department of Anesthesiology administrative office and the 14th floor Pain Center in the 
Lavin Pavilion. The computers are backed up every night to the Department of 
Anesthesiology server located on the 5th floor Arkes pavilion. A key card and key are 
required and is only accessible by the Department of Anesthesiology IT administrator. 
The server is remotely backed up nightly.   
 
Each study subject will be assigned a study code number. The code will be used to link 
study data to patient identification (name) in a separate database.  Data access will be 
password protected and only available to study investigators. 
 
PROVISIONS TO PROTECT THE PRIVACY INTERESTS OF PARTICIPANTS: 
The subject will have multiple interactions with the study team. The first interaction will 
be to discuss and obtain written informed consent; then 24 hours and 1 week following 
the injection for a brief period by telephone.  These brief interactions limit the amount of 
intrusion into the subject’s post-injection recovery.   
 
Procedures will be completed by a study team member who will remind the participant 
why this encounter is occurring with the study team.  
 
The research study team may only view the data sheets and the subject’s medical 
record in Powerchart and EPIC for selected data within the parameters of the study. 
  
 
COMPENSATION FOR RESEARCH-RELATED INJURY:   
No compensation will be provided to participants for research related injury. 
ECONOMIC BURDEN TO PARTICIPANTS: 

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There is no additional cost charged to patients who participate in this study, as 
compared to those patients not in a study who receive a CESI.  
 
CONSENT PROCESS: 
Potential subjects will be approached by study team members in the Pain Center. They 
will be able to review the consent document either on paper or on the dedicated 
(encrypted and password protected) study tablet owned by the Department of 
Anesthesiology. They will be consented before their planned procedure. The consent 
will be stored in HIPAA compliant REDcap. The subject’s copy of the signed consent 
will be forwarded electronically to their individual E-mail account. If they do not have E-
mail access a paper copy will be provided. A copy of the consent document will also be 
available in REDcap.  A copy of the consent will also be uploaded to Enotis.  The 
research study team will be following SOP: Informed Consent Process for Research 
(HRP-090). The study team will spend greater than 10 minutes discussing the consent 
document and the procedures involved. 
 
Ample time will be allowed for patient to ask questions regarding the study and the 
consent document. The subject will also be informed that there is no conflict of interest 
between the PI and the protocol. The PI will not receive financial remuneration nor will 
the study participation affect the subject’s medical bills. 
 
Waiver or Alteration of Consent Process: No waiver of consent is being sought.  
 
Participants who are not yet adults (infants, children, teenagers) and adults unable to 
provide consent will not be included in this study.  
 
PROCESS TO DOCUMENT CONSENT IN WRITING: 
SOP Written Documentation of Consent (HRP-091) has been reviewed. Consent 
document will be attached to the IRB application. HIPAA compliant REDcap will host the 
electronic version of the consent document to allow electronic signatures of participants 
on the consent document.    
 
DRUGS OR DEVICES: 
The research study team will be blinded to the participant’s group assignment in this 
study. Drugs are stocked in an Omnicell machine in the Pain Center. The provider will 
administer the study drug to the patient during the CESI. 
 
 
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