The Use of Local Anesthetic in Intralesional Corticosteroid Injections; A Randomized, Double Blind Controlled Trial
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
This arm will include an injection mixture of corticosteroid and lidocaine
Intervention: Corticosteroid with lidocaine (Drug)
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.
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
Brian Drolet
Assistant Professor
Vanderbilt University Medical Center