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Pain Outcomes Following Intralesional Corticosteroid Injections

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03630198
Recruitment Status : Recruiting
First Posted : August 14, 2018
Last Update Posted : January 31, 2019
Information provided by (Responsible Party):
Brian Drolet, 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.

Condition or disease Intervention/treatment Phase
Keloid Alopecia Areata Acne Hypertrophic Scar Epidermal Inclusion Cyst Frontal Fibrosing Alopecia Lichen Plano-Pilaris Keratoacanthoma Plaque Psoriasis Lichen Simplex Chronicus Prurigo Nodularis Nummular Eczema Granuloma Annulare Morphea Lichen Planus Drug: Corticosteroid with lidocaine Drug: Corticosteroid with normal saline Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Use of Local Anesthetic in Intralesional Corticosteroid Injections; A Randomized, Double Blind Controlled Trial
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Arm Intervention/treatment
Active Comparator: Corticosteroid with lidocaine
This arm will include an injection mixture of corticosteroid and lidocaine
Drug: Corticosteroid with 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.
Drug: Corticosteroid with normal saline
Intralesional corticosteroid injection

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Pain Outcome: visual analog scale [ Time Frame: Assessed 6 hours after injection (by phone), and 24 hours after injection (by phone) ]
    Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever.

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03630198

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Contact: Brian C Drolet, MD (615) 322-7311

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United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37235
Contact: Brian C Drolet, MD         
Sponsors and Collaborators
Vanderbilt University Medical Center
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Principal Investigator: Brian Drolet, MD Vanderbilt University Medical Center

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Responsible Party: Brian Drolet, Assistant Professor, Vanderbilt University Medical Center Identifier: NCT03630198     History of Changes
Other Study ID Numbers: 181119
First Posted: August 14, 2018    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: IPD will not be shared with other researchers

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Brian Drolet, Vanderbilt University Medical Center:
local anesthetic
Additional relevant MeSH terms:
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Epidermal Cyst
Alopecia Areata
Lichen Planus
Granuloma Annulare
Cicatrix, Hypertrophic
Skin Diseases, Papulosquamous
Skin Diseases
Hair Diseases
Pathological Conditions, Anatomical
Skin Diseases, Eczematous
Lichenoid Eruptions
Collagen Diseases
Connective Tissue Diseases
Pathologic Processes
Lymphoproliferative Disorders
Lymphatic Diseases
Necrobiotic Disorders
Anesthetics, Local