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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Corticosteroid with lidocaine | Active Comparator | This arm will include an injection mixture of corticosteroid and lidocaine |
|
| Corticosteroid with normal saline | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corticosteroid with lidocaine | Drug | Intralesional corticosteroid injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Outcome: Visual Analog Scale | Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever. | Assessed 1 minute after the injection (in clinic) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brian Drolet, MD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37235 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33760691 | Derived | Zakria D, Patrinely JR Jr, Dewan AK, Albers SE, Wheless LE, Simmons AN, Drolet BC. Intralesional corticosteroid injections are less painful without local anesthetic: a double-blind, randomized controlled trial. J Dermatolog Treat. 2022 Jun;33(4):2034-2037. doi: 10.1080/09546634.2021.1906842. Epub 2021 Apr 7. |
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IPD will not be shared with other researchers
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| ID | Title | Description |
|---|---|---|
| FG000 | Corticosteroid With Lidocaine | This arm will include an injection mixture of corticosteroid and lidocaine Corticosteroid with lidocaine: Intralesional corticosteroid injection |
| FG001 | Corticosteroid With Normal Saline |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Aug 1, 2018 |
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| Corticosteroid with normal saline | Drug | Intralesional corticosteroid injection |
|
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.
Corticosteroid with normal saline: Intralesional corticosteroid injection
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Corticosteroid With Lidocaine | This arm will include an injection mixture of corticosteroid and lidocaine Corticosteroid with lidocaine: Intralesional corticosteroid injection |
| BG001 | Corticosteroid With Normal Saline | 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. Corticosteroid with normal saline: Intralesional corticosteroid injection |
| BG002 | Total | Total of all reporting groups |
| 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 | Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 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 | Pain Outcome: Visual Analog Scale | Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever. | Posted | Mean | Standard Deviation | Score on a scale | Assessed 1 minute after the injection (in clinic) |
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| Post-Hoc | Pain Outcome: Visual Analog Scale | Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever. | Posted | Mean | Standard Deviation | Score on a scale | Assessed at 6 hours and 24 hours after injection |
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|
1 year after injection
No difference
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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 | Corticosteroid With Lidocaine | This arm will include an injection mixture of corticosteroid and lidocaine Corticosteroid with lidocaine: Intralesional corticosteroid injection | 0 | 13 | 0 | 13 | 0 | 13 |
| EG001 | Corticosteroid With Normal Saline | 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. Corticosteroid with normal saline: Intralesional corticosteroid injection | 0 | 18 | 0 | 18 | 0 | 18 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Brian Drolet | Vanderbilt Univeristy Medical center | 615-322-2918 | brian.c.drolet@vumc.org |
| Jan 10, 2021 |
| Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D007627 | Keloid |
| D000506 | Alopecia Areata |
| D000152 | Acne Vulgaris |
| D017439 | Cicatrix, Hypertrophic |
| D003884 | Dermoid Cyst |
| D008010 | Lichen Planus |
| D007636 | Keratoacanthoma |
| D009450 | Neurodermatitis |
| D016460 | Granuloma Annulare |
| D012594 | Scleroderma, Localized |
| ID | Term |
|---|---|
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D002921 | Cicatrix |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000505 | Alopecia |
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017486 | Acneiform Eruptions |
| D012625 | Sebaceous Gland Diseases |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D013724 | Teratoma |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D017512 | Lichenoid Eruptions |
| D017444 | Skin Diseases, Papulosquamous |
| D003872 | Dermatitis |
| D017443 | Skin Diseases, Eczematous |
| D017441 | Necrobiotic Disorders |
| D006099 | Granuloma |
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| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| D008012 | Lidocaine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Between 18 and 65 years |
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| >=65 years |
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