- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03630198
Pain Outcomes Following Intralesional Corticosteroid Injections
The Use of Local Anesthetic in Intralesional Corticosteroid Injections; A Randomized, Double Blind Controlled Trial
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Tennessee
-
Nashville, Tennessee, United States, 37235
- Vanderbilt University Medical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Corticosteroid with lidocaine
This arm will include an injection mixture of corticosteroid and lidocaine
|
Intralesional corticosteroid injection
|
Experimental: 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.
|
Intralesional corticosteroid injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Assessed 1 minute after the injection (in clinic)
|
Collaborators and Investigators
Investigators
- Principal Investigator: Brian Drolet, MD, Vanderbilt University Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Skin Diseases
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Cysts
- Connective Tissue Diseases
- Pathological Conditions, Anatomical
- Skin Diseases, Papulosquamous
- Fibrosis
- Dermatitis
- Skin Diseases, Eczematous
- Cicatrix
- Hypotrichosis
- Hair Diseases
- Collagen Diseases
- Lichenoid Eruptions
- Necrobiotic Disorders
- Granuloma
- Alopecia
- Alopecia Areata
- Lichen Planus
- Prurigo
- Neurodermatitis
- Cicatrix, Hypertrophic
- Keratoacanthoma
- Granuloma Annulare
- Epidermal Cyst
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
Other Study ID Numbers
- 181119
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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