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NCT03630198 Clinical Trial

Pain Outcomes Following Intralesional Corticosteroid Injections

Plaque Psoriasis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03630198
Other study ID # 181119
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date October 1, 2018
Est. completion date September 1, 2019

Study information
Verified date February 2021
Source Vanderbilt University Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 31
Est. completion date September 1, 2019
Est. primary completion date September 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

  • Acne
  • Alopecia
  • Alopecia Areata
  • Cicatrix, Hypertrophic
  • Epidermal Cyst
  • Epidermal Inclusion Cyst
  • Frontal Fibrosing Alopecia
  • Granuloma
  • Granuloma Annulare
  • Hypertrophic Scar
  • Keloid
  • Keratoacanthoma
  • Lichen Plano-Pilaris
  • Lichen Planus
  • Lichen Simplex Chronicus
  • Morphea
  • Neurodermatitis
  • Nummular Eczema
  • Plaque Psoriasis
  • Prurigo
  • Prurigo Nodularis

Intervention

Drug:
• Corticosteroid with lidocaine
Intralesional corticosteroid injection
• Corticosteroid with normal saline
Intralesional corticosteroid injection

Locations
Country Name City State
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (1)
Lead Sponsor Collaborator
Vanderbilt University Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Pain Outcome: Visual Analog Scale 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)
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