Pain Outcomes Following Intralesional Corticosteroid Injections

NCT ID: NCT03630198

Last Updated: 2021-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2019-09-01

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Corticosteroid with lidocaine

This arm will include an injection mixture of corticosteroid and lidocaine

Group Type: ACTIVE_COMPARATOR

Corticosteroid with lidocaine

Intervention Type: DRUG

Intralesional corticosteroid injection

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.

Group Type: EXPERIMENTAL

Corticosteroid with normal saline

Intervention Type: DRUG

Intralesional corticosteroid injection

Interventions

Corticosteroid with lidocaine

Intralesional corticosteroid injection

Intervention Type: DRUG

Corticosteroid with normal saline

Intralesional corticosteroid injection

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Vanderbilt University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Brian Drolet

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brian Drolet, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University Medical Center

Locations

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 33760691 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

181119

Identifier Type: -

Identifier Source: org_study_id