Clinical trial NCT03630198
Conditions: Keloid Alopecia Areata Acne Hypertrophic Scar Epidermal Inclusion Cyst Frontal Fibrosing Alopecia Lichen Plano-Pilaris Keratoacanthoma Plaque Psoriasis Lichen Simplex Chronicus Prurigo Nodularis Nummular Eczema Granuloma Annulare Morphea Lichen Planus
Keywords: corticosteroid local anesthetic
Sponsor: Vanderbilt University Medical Center
Start date: 2018-10-01; Completion date: 2019-09-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Corticosteroid therapy, including intralesional and topical applications, has many indications within the fields of Dermatology, Plastic Surgery, and Orthopedics. However, these injections can be quite painful, which leads many patients to discontinue treatment.

Often, the injection involves a mixture of local anesthetic and corticosteroids despite a lack of evidence that the use of lidocaine improves pain. Due to the acidic pH, the lidocaine component of the injection can actually cause a significant burning sensation during the procedure. Lidocaine does not have anti-inflammatory properties and does not treat the underlying pathology. By including another medication, lidocaine also adds cost and risk to the procedure.

The purpose of this study is to see if removing lidocaine from intralesional injections decreases the pain of injection.

Detailed description:

Arms: arm 1: This arm will include an injection mixture of corticosteroid and lidocaine arm 2: This arm will include a mixture of corticosteroid and normal saline. The purpose of normal saline is to keep the volume and concentration similar when compared to the injections containing lidocaine.
Interventions: intervention 1: Corticosteroid with lidocaine intervention 2: Corticosteroid with normal saline
Intervention descriptions: intervention 1: Intralesional corticosteroid injection intervention 2: Intralesional corticosteroid injection

Protocol documents:
Prot_SAP_000.pdf: 
 
 
 
 
 
 
Pain Outcomes Following Intralesional Corticosteroid  
Injections 
 
 
NCT03630198 
 
8/1/2018 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
 
 
 
Table of Contents: 
 
1. Background 
2. Rationale and Specific Aims 
3. Animal Studies and Previous Human Studies 
4. Inclusion/Exclusion Criteria 
5. Enrollment/Randomization 
6. Study Procedures 
7. Risks of Investigational Agents/Devices (side effects) 
8. Reporting of Adverse Events or Unanticipated Problems involving Risk to 
Participants or Others 
9. Study Withdrawal/Discontinuation 
10. 
Statistical Considerations 
11. 
Privacy/Confidentiality Issues 
12. 
Follow-up and Record Retention 
13. 
References 
 
 
Appendices 
 
Appendix A Visual Analog Scale  
 
 


 
1. 
Background 
 
 
Corticosteroid therapy, including intralesional and topical applications, has many 
indications within the fields of Dermatology, Plastic Surgery, and Orthopedics. However, 
these injections can be quite painful, which leads many patients to discontinue 
treatment. 
 
Often, the injection involves a mixture of local anesthetic and corticosteroids 
despite a lack of evidence that the use of lidocaine improves pain.1,2  Due to the acidic 
pH, the lidocaine component of the injection can actually cause a significant burning 
sensation during the procedure. Lidocaine does not have anti-inflammatory properties 
and does not treat the underlying pathology. By including another medication, lidocaine 
also adds cost and risk to the procedure.  
 
In a double blind, randomized control trial, Osanakornkul and Burusapat studied 
the benefit of applying topical anesthetics or a 1:1 mixture of 1% lidocaine and 
triamcinolone acetonide at the injection site to alleviate pain during keloid treatment.2 
While the use of a topical anesthetic 1 hour prior to the injection was able to alleviate 
the pain from needle stick, the study did not show a statistical difference in pain 
outcomes with the use of lidocaine. However, this study was limited to the use of 
intralesional corticosteroid injections for the treatment of keloids. In addition, the study 
only focused on 3 locations: the shoulder, sternum, and ear. Keloid injections are often 
more painful than other injections because the horizontal penetration of the needle can 
pierce a large number of nerve endings. In routine injections, the entry of the needle is 
either vertical or angled and thus pierces a small number of nerve endings.3  In addition, 
the injected material stretches nerve endings and compresses them against unyielding 
keloid tissue, causing substantial pain that can persist up to several hours after the 
procedure.3 This study will examine intralesional corticosteroid injections for keloids, 
alopecia areata, and other indications while including a wider variety of injection sites.  
 
 
2. 
Rationale and Specific Aims 
 
The purpose of this study is to see if removing lidocaine from intralesional injections 
decreases pain of the injection. We hypothesize there will be no difference in pain 
outcomes if lidocaine is removed from intralesional corticosteroid injections. 
 
3. 
Animal Studies and Previous Human Studies 
 
A similar study was conducted in plastic surgery with intraarticular injections for trigger 
finger. The project examined pain outcomes for injections containing steroid + normal 
saline vs steroid + local anesthetic. The results indicated that injections containing local 
anesthetic were significantly more painful. Thus, including a mixed local anesthetic in 
the injection adds unnecessary cost and risk to the procedure. Because steroid injections 
in dermatology are also commonly mixed with a local anesthetic, this study design can 
be applied to these intralesional injections as well. 
 
 
 
 


 
 
4. 
Inclusion/Exclusion Criteria 
 
Inclusion Criteria: 
• >12 years old presenting with an indication for intralesional steroid injection 
 
Exclusion Criteria: 
• Not a candidate for corticosteroid injection 
• Contraindication to lidocaine 
 
5. 
Enrollment/Randomization 
 
All patients meeting inclusion/exclusion criteria will be offered enrollment. Using a coin 
flip, patients will have a 50% chance of receiving one of the following treatments: 
1. Corticosteroid + lidocaine 
2. Corticosteroid + normal saline   
 
 
6. 
Study Procedures 
 
Day 1 (In clinic): After diagnosing the need for an intralesional injection, patients will be 
screened for enrollment. The consent form will be reviewed in depth to describe the 
purpose and procedures associated with the study. If they agree to be part of the study, 
we will collect the following demographic information: 
• MRN 
• Age 
• Gender 
• Comorbidities (chronic opioid use, smoking, diabetes, neuropathy, fibromyalgia) 
• Phone number 
• Site of injection (scalp, face, neck, and trunk)  
• Indication for injection 
 
The patient will then be randomized to receive one of the following injections: 
 
1. Corticosteroid with normal saline 
 
2. Corticosteroid with lidocaine 
 
A co-investigator will prepare the syringe to ensure blinding. The injection site will be 
prepped in sterile fashion with an alcohol wipe. The physician will then administer the 
injection. Immediately following the injection, the patient will be asked to rate the pain 
of the injection based on the visual analog scale (appendix A). Specifically, the co-
investigator will say “Rate the injection experience on a scale of 0 to 10, 0 being no pain 
and 10 being the worst pain of your life”. A bandaid will be placed over the injection site 
and the patient will be reminded to expect a phone call that afternoon and the next day.  
 
Day 1 (after clinic): Approximately 6 hours after the injection, a different study 
investigator will call the patient by phone to assess their current pain level with the 
visual analog scale. Using a different investigator who is unaware of the treatment arm 
for follow-up will further ensure blinding. Specifically, the investigator will say “Rate your 


 
current pain level from the injection on a scale of 0 to 10, 0 being no pain and 10 being 
the worst pain of your life”. Patients will be called up to three times before being 
considered lost to follow-up.  
 
Day 2: Approximately 24 hours after the injection, the study investigator will again call 
the patient by phone to assess their current pain level with the visual analog scale. 
Specifically, the investigator will say “Rate your current pain level from the injection on a 
scale of 0 to 10, 0 being no pain and 10 being the worst pain of your life”. Patients will 
then be thanked for their involvement in the study and encouraged to reach out to the 
principle investigator or clinic should any problems arise. Patients will be called up to 
three times before being considered lost to follow-up. 
 
7. 
Risks 
 
This study is categorized as less than minimal risk.  We are comparing two treatment 
methods that are accepted as standard of care, and are already used on the clinic 
population being studied on a daily basis.  There is no new experimental intervention 
that would put patients at greater than minimal risk. Although rare, the risks of a 
corticosteroid injection include hypopigmentation, skin atrophy, and hyperglycemia in 
patients with diabetes. There is also a small risk of an allergic reaction to the lidocaine 
component. There may be unknown or unanticipated adverse effects.  
 
 
8. 
Reporting of Adverse Events or Unanticipated Problems involving Risk 
to Participants or Others 
 
Adverse events will be reported to the IRB immediately through standard reporting 
mechanisms.  
 
9. 
Study Withdrawal/Discontinuation 
 
 
There are no anticipated circumstances under which subjects would be withdrawn from 
research without their consent. If subjects withdraw, there will be no penalty or 
consequences.   
 
 
10. 
Statistical Plan 
 
We are planning a study of a continuous response variable from independent control 
and experimental subjects with 1.1538 control(s) per experimental subject.  In a previous 
study the response within each subject group was normally distributed with standard 
deviation 0.3.  If the true difference in the experimental and control means is 0.2, we will 
need to study 34 experimental subjects and 39 control subjects to be able to reject the 
null hypothesis that the population means of the experimental and control groups are 
equal with probability (power) 0.8.  The Type I error probability associated with this test 
of this null hypothesis is 0.05. 


 
 
 
11. 
Privacy/Confidentiality Issues 
 
Private health information (PHI) will used in the study, but not disclosed. All PHI will be 
stored on a secure, password-locked server. All participants in the study have obtained 
Human Research certification to have the necessary authorization to PHI. When 
collecting patient data, only medical record numbers will be used to identify patients.  
 
12. 
Follow-up and Record Retention 
 
The study will last for approximately 1 year after initiation or until the enrollment goal is 
met. At the study conclusion, all identifiable data will be destroyed and de-identified 
data will be kept for analysis.  
 
13. References:  
 
1. Osterne RL, Araújo PM, de Souza-Carvalho AC, Cavalcante RB, Sant’Ana E, Nongueira 
RL. Intralesional corticosteroid injections in the treatment of central giant cell lesions of 
the jaws: A meta-analytic study. Medicina Oral, Patología Oral y Cirugía Bucal. 
2013;18(2):e226-e232. doi:10.4317/medoral.18345. 
 
2. Usanakornkul, A., & Burusapat, C. (2017). A Topical Anesthetic and Lidocaine Mixture 
for Pain Relief During Keloid Treatment. Dermatologic Surgery, 43(1), 66-73. 
doi:10.1097/dss.0000000000000932 
 
3. Mishra S Safe and less painful injection of triamcinolone acetonide into a keloid—a 
technique. J Plast Reconstr Aesthet Surg 63:e205 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
Appendices: 
 
Appendix A