Pain Outcomes Following Intralesional Corticosteroid Injections

Study Overview
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Brief Summary
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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.

Official Title
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The Use of Local Anesthetic in Intralesional Corticosteroid Injections; A Randomized, Double Blind Controlled Trial

Conditions
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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

Intervention / Treatment
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* Drug: Corticosteroid with lidocaine
* Drug: Corticosteroid with normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: >12 years old presenting with an indication for intralesional steroid injection Exclusion Criteria: Unconsentable Not a candidate for corticosteroid injection Contraindication to lidocaine

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Corticosteroid with lidocaine<br>This arm will include an injection mixture of corticosteroid and lidocaine | Drug: Corticosteroid with lidocaine<br>* Intralesional corticosteroid injection<br>|
| Experimental: Corticosteroid with normal saline<br>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. | Drug: Corticosteroid with normal saline<br>* Intralesional corticosteroid injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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corticosteroid, local anesthetic