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Clinical Trials/NCT03630198
NCT03630198CompletedPhase 4

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

Vanderbilt University Medical Center1 site in 1 country31 target enrollmentStarted: October 1, 2018Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 4
Status
Completed
Enrollment
31
Locations
1
Primary Endpoint
Pain Outcome: Visual Analog Scale

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Care Provider, Outcomes Assessor)

Eligibility Criteria

Ages
12 Years to — (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Arms & Interventions

Corticosteroid with lidocaine

Active Comparator

This arm will include an injection mixture of corticosteroid and lidocaine

Intervention: Corticosteroid with lidocaine (Drug)

Corticosteroid with normal saline

Experimental

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.

Intervention: Corticosteroid with normal saline (Drug)

Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Brian Drolet

Assistant Professor

Vanderbilt University Medical Center

Study Sites (1)

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