NCT03630198

Pain Outcomes Following Intralesional Corticosteroid Injections

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Vanderbilt University Medical Center · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DRUG	Corticosteroid with lidocaine	Intralesional corticosteroid injection
DRUG	Corticosteroid with normal saline	Intralesional corticosteroid injection

Timeline

• Start date: 2018-10-01
• Primary completion: 2019-09-01
• Completion: 2019-09-01
• First posted: 2018-08-14
• Last updated: 2021-03-11
• Results posted: 2021-03-11

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study