Acne, Alopecia Areata, Epidermal Inclusion Cyst, Frontal Fibrosing Alopecia, Granuloma Annulare, Hypertrophic Scar, Keloid, Keratoacanthoma, Lichen Plano-Pilaris, Lichen Planus, Lichen Simplex Chronicus, Morphea, Nummular Eczema, Plaque Psoriasis, Prurigo Nodularis
Conditions
Keywords
corticosteroid, local anesthetic
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.
Interventions
DRUGCorticosteroid with lidocaine
Intralesional corticosteroid injection
Intralesional corticosteroid injection
Sponsors
Vanderbilt University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Outcome: Visual Analog Scale | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Corticosteroid With Lidocaine This arm will include an injection mixture of corticosteroid and lidocaine
Corticosteroid with lidocaine: Intralesional corticosteroid injection | 13 |
| 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.
Corticosteroid with normal saline: Intralesional corticosteroid injection | 18 |
| Total | 31 |
Baseline characteristics
| Characteristic | Corticosteroid With Normal Saline | Total | Corticosteroid With Lidocaine |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants | 31 Participants | 13 Participants |
| Age, Continuous | 52 years STANDARD_DEVIATION 19.2 | 43 years STANDARD_DEVIATION 20.3 | 33 years STANDARD_DEVIATION 18.2 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 18 Participants | 31 Participants | 13 Participants |
| Sex: Female, Male Female | 10 Participants | 16 Participants | 6 Participants |
| Sex: Female, Male Male | 8 Participants | 15 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 18 |
| other Total, other adverse events | 0 / 13 | 0 / 18 |
| serious Total, serious adverse events | 0 / 13 | 0 / 18 |
Outcome results
Primary
Pain Outcome: Visual Analog Scale
Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever.
Time frame: Assessed 1 minute after the injection (in clinic)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Corticosteroid With Lidocaine | Pain Outcome: Visual Analog Scale | 5.4 Score on a scale | Standard Deviation 2.4 |
| Corticosteroid With Normal Saline | Pain Outcome: Visual Analog Scale | 2.7 Score on a scale | Standard Deviation 2.3 |
Post Hoc
Pain Outcome: Visual Analog Scale
Assessed using the visual analog scale (0-10 scale). Zero indicates no pain, 10 indicates worst pain ever.
Time frame: Assessed at 6 hours and 24 hours after injection
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Corticosteroid With Lidocaine | Pain Outcome: Visual Analog Scale | Pain (6 hour) | 0.9 Score on a scale | Standard Deviation 2.1 |
| Corticosteroid With Lidocaine | Pain Outcome: Visual Analog Scale | Pain (24 hour) | 0 Score on a scale | Standard Deviation 0 |
| Corticosteroid With Normal Saline | Pain Outcome: Visual Analog Scale | Pain (6 hour) | 0.1 Score on a scale | Standard Deviation 1.5 |
| Corticosteroid With Normal Saline | Pain Outcome: Visual Analog Scale | Pain (24 hour) | 0 Score on a scale | Standard Deviation 0 |