Pain Outcomes Following Intralesional Corticosteroid Injections

Vanderbilt University Medical Center

Status and phase: Completed; Phase 4

Conditions: Granuloma Annulare; Acne; Lichen Planus; Epidermal Inclusion Cyst; Morphea; Nummular Eczema; Keratoacanthoma; Alopecia Areata; Keloid; Prurigo Nodularis; Lichen Simplex Chronicus; Hypertrophic Scar; Plaque Psoriasis; Frontal Fibrosing Alopecia; Lichen Plano-Pilaris

Treatments: Drug: Corticosteroid with normal saline; Drug: Corticosteroid with lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT03630198

181119

Details and patient eligibility

About

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.

Enrollment: 31 patients

Sex: All

Ages: 12+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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31 participants in 2 patient groups

Corticosteroid with lidocaine

Active Comparator group

Description:

This arm will include an injection mixture of corticosteroid and lidocaine

Treatment:

Drug: Corticosteroid with lidocaine

Corticosteroid with normal saline

Experimental group

Description:

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.

Treatment:

Drug: Corticosteroid with normal saline