Pain Outcomes Following Intralesional Corticosteroid Injections

Phase 4

Completed

• Conditions: Hypertrophic Scar; Alopecia Areata; Acne; Epidermal Inclusion Cyst; Frontal Fibrosing Alopecia; Keratoacanthoma; Plaque Psoriasis; Keloid; Prurigo Nodularis; Nummular Eczema
• Interventions: Drug: Corticosteroid with normal saline; Drug: Corticosteroid with lidocaine

• Registration Number: NCT03630198
• Lead Sponsor: Vanderbilt University Medical Center

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-08-09
• Study First Submitted QC: 2018-08-13
• Study First Posted: 2018-08-14
• Study Start: 2018-10-01
• Primary Completion: 2019-09-01
• Study Completion: 2019-09-01
• Results First Submitted: 2021-01-10
• Status Verified: 2021-02
• Results First Submitted QC: 2021-02-18
• Last Update Submitted: 2021-02-18
• Results First Posted: 2021-03-11
• Last Update Posted: 2021-03-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

• >12 years old presenting with an indication for intralesional steroid injection

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Exclusion Criteria

• Unconsentable
• Not a candidate for corticosteroid injection
• Contraindication to lidocaine

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Corticosteroid with normal saline	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.
Corticosteroid with lidocaine	Corticosteroid with lidocaine	This arm will include an injection mixture of corticosteroid and lidocaine

Primary Outcome Measures

Name	Time	Method
Pain Outcome: Visual Analog Scale	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.

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States