CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 31 enrolled
Drug / intervention
Corticosteroid with lidocaine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03630198
NCT03630198Phase 4Completed

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

Vanderbilt University Medical Center·interventional·Posted Aug 14, 2018·Updated Mar 11, 2021

In Brief

A Phase 4 clinical trial evaluating Corticosteroid with lidocaine and Corticosteroid with normal saline for Keloid and 14 related conditions. Completed, enrolled 31 participants across 1 site.

Detailed 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.

Study Details

Timeline

Phase 4CompletedFinished
20192020202120222023202420252026
First PostedAug 14, 2018
Enrollment StartOct 1, 2018
Primary CompletionSep 1, 2019
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 7.9 years ago

Interventions

Corticosteroid with lidocainedrug

Intralesional corticosteroid injection

Corticosteroid with normal salinedrug

Intralesional corticosteroid injection