Pain Outcomes Following Intralesional Corticosteroid Injections

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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Key information

Conditions

Keloid Acne Acne Vulgaris Acneiform Eruptions Alopecia Alopecia Areata Cicatrix Cicatrix, Hypertrophic Collagen Diseases Connective Tissue Diseases Cysts Dermatitis Dermoid Cyst Epidermal Inclusion Cyst Fibrosis Frontal Fibrosing Alopecia Granuloma Granuloma Annulare Hair Diseases Hypertrophic Scar Hypotrichosis Keratoacanthoma Lichen Plano-Pilaris Lichen Planus Lichen Simplex Chronicus Lichenoid Eruptions Morphea Necrobiotic Disorders Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neurodermatitis Nummular Eczema Pathologic Processes Pathological Conditions, Signs and Symptoms Plaque Psoriasis Prurigo Nodularis Scleroderma, Localized Sebaceous Gland Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases Teratoma

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37235, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Corticosteroid with lidocaine

Drug

Intralesional corticosteroid injection

Corticosteroid with normal saline

Drug

Intralesional corticosteroid injection

Primary outcomes

Pain Outcome: Visual Analog Scale

Time frame: Assessed 1 minute after the injection (in clinic)

Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever.

Sponsors and collaborators

Lead sponsor

Vanderbilt University Medical Center

Other

Registry information

Official study title

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

Important dates

Study start: 2018
Primary completion: 2019
Study completion: 2019
First posted: Aug 14, 2018
Registry last updated: Mar 11, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed