Pain Outcomes Following Intralesional Corticosteroid Injections

• Sponsor: Vanderbilt University Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03630198
• Collaborator: (none)
• Enrollment: 31
• Location: 1
• Arms: 2
• Actual Duration (Months): 11
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 31 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: Oct 1, 2018
• Actual Primary Completion Date: Sep 1, 2019
• Actual Study Completion Date: Sep 1, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 12 Years and Older
• 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37235

Sponsors and Collaborators

• Vanderbilt University Medical Center

Investigators

• Principal Investigator: Brian Drolet, MD, Vanderbilt University Medical Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 1, 2018

More Information

Publications

None provided.

• Responsible Party: Brian Drolet, Assistant Professor, Vanderbilt University Medical Center
• ClinicalTrials.gov Identifier: NCT03630198
• Other Study ID Numbers: 181119
• First Posted: Aug 14, 2018
• Last Update Posted: Mar 11, 2021
• Last Verified: Feb 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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, Assistant Professor, Vanderbilt University Medical Center: corticosteroid; local anesthetic
• Additional relevant MeSH terms: Epidermal Cyst; Granuloma; Alopecia; Alopecia Areata; Lichen Planus; Prurigo; Granuloma Annulare; Neurodermatitis; Keratoacanthoma; Cicatrix, Hypertrophic; Lidocaine

Study Results

Participant Flow

Arm/Group Title	Corticosteroid With Lidocaine	Corticosteroid With Normal Saline
Arm/Group Description	This arm will include an injection mixture of corticosteroid and lidocaine Corticosteroid with lidocaine: Intralesional corticosteroid injection	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
Period Title: Overall Study
STARTED	13	18
COMPLETED	13	18
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Corticosteroid With Lidocaine	Corticosteroid With Normal Saline	Total
Arm/Group Description	This arm will include an injection mixture of corticosteroid and lidocaine Corticosteroid with lidocaine: Intralesional corticosteroid injection	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	Total of all reporting groups
Overall Participants	13	18	31
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	13 100%	18 100%	31 100%
>=65 years	0 0%	0 0%	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	33 (18.2)	52 (19.2)	43 (20.3)
Sex: Female, Male (Count of Participants)
Female	6 46.2%	10 55.6%	16 51.6%
Male	7 53.8%	8 44.4%	15 48.4%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
United States	13 100%	18 100%	31 100%

Outcome Measures

1. Primary Outcome

Title	Pain Outcome: Visual Analog Scale
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Corticosteroid With Lidocaine	Corticosteroid With Normal Saline
Arm/Group Description	This arm will include an injection mixture of corticosteroid and lidocaine Corticosteroid with lidocaine: Intralesional corticosteroid injection	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
Measure Participants	13	18
Mean (Standard Deviation) [Score on a scale]	5.4 (2.4)	2.7 (2.3)

2. Post-Hoc Outcome

Title	Pain Outcome: Visual Analog Scale
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Corticosteroid With Lidocaine	Corticosteroid With Normal Saline
Arm/Group Description	This arm will include an injection mixture of corticosteroid and lidocaine Corticosteroid with lidocaine: Intralesional corticosteroid injection	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
Measure Participants	13	18
Pain (6 hour)	0.9 (2.1)	0.1 (1.5)
Pain (24 hour)	0 (0)	0 (0)

Adverse Events

Time Frame	1 year after injection
Adverse Event Reporting Description	No difference
Arm/Group Title	Corticosteroid With Lidocaine		Corticosteroid With Normal Saline
Arm/Group Description	This arm will include an injection mixture of corticosteroid and lidocaine Corticosteroid with lidocaine: Intralesional corticosteroid injection		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
All Cause Mortality
	Corticosteroid With Lidocaine		Corticosteroid With Normal Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/18 (0%)
Serious Adverse Events
	Corticosteroid With Lidocaine		Corticosteroid With Normal Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/18 (0%)
Other (Not Including Serious) Adverse Events
	Corticosteroid With Lidocaine		Corticosteroid With Normal Saline
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/13 (0%)		0/18 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.