Injectable Lidocaine Versus Lidocaine/Tetracaine Patch for the Incision and Drainage of Skin Abscesses
Primary Purpose
Cutaneous Abscess, Pain
Status
Completed
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Lidocaine/tetracaine patch
1% lidocaine
Sponsored by
About this trial
This is an interventional supportive care trial for Cutaneous Abscess focused on measuring local anesthetic, incision and drainage, pain, cutaneous abscess
Eligibility Criteria
Inclusion Criteria:
- Age>18 years
- Skin abscess in need of incision and drainage (judged by treating physician)
Exclusion Criteria:
- Allergy to lidocaine or tetracaine
- Non-intact skin
- Unable/unwilling to provide informed consent
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Lidocaine Injection
Lidocaine/tetracaine patch
Arm Description
Incision and drainage performed after patient received placebo patch with injection of 1% lidocaine into the site of the abscess.
Incision and drainage performed after patient received active lidocaine/tetracaine patch and injection of 10cc of saline into site of abscess
Outcomes
Primary Outcome Measures
Change in VAS pain score over time
VAS measured at each of the 3 time points noted above.
Secondary Outcome Measures
Full Information
NCT ID
NCT02066818
First Posted
November 18, 2013
Last Updated
February 18, 2014
Sponsor
East Carolina University
1. Study Identification
Unique Protocol Identification Number
NCT02066818
Brief Title
Injectable Lidocaine Versus Lidocaine/Tetracaine Patch for the Incision and Drainage of Skin Abscesses
Official Title
Injectable Lidocaine Provides Similar Analgesia Compared to Transdermal Lidocaine/Tetracaine Patch for the Incision and Drainage of Skin Abscesses: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2014
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
East Carolina University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Local anesthesia used for incision and drainage of abscesses is known to be painful.
We studied the analgesia provided by a lidocaine/tetracaine patch compared to injectable lidocaine during incision and drainage (I&D) of skin abscesses.
Local injection of lidocaine provided similar analgesia compared to the lidocaine/tetracaine patch during I&D of skin abscesses in the Emergency Department. Pain at presentation and following the procedure was similar in both groups.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutaneous Abscess, Pain
Keywords
local anesthetic, incision and drainage, pain, cutaneous abscess
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lidocaine Injection
Arm Type
Active Comparator
Arm Description
Incision and drainage performed after patient received placebo patch with injection of 1% lidocaine into the site of the abscess.
Arm Title
Lidocaine/tetracaine patch
Arm Type
Experimental
Arm Description
Incision and drainage performed after patient received active lidocaine/tetracaine patch and injection of 10cc of saline into site of abscess
Intervention Type
Drug
Intervention Name(s)
Lidocaine/tetracaine patch
Other Intervention Name(s)
Synera patch
Intervention Type
Drug
Intervention Name(s)
1% lidocaine
Primary Outcome Measure Information:
Title
Change in VAS pain score over time
Description
VAS measured at each of the 3 time points noted above.
Time Frame
Immediately prior to starting I&D (Time 0); 2-5 minutes after start of I&D (Time 1); within 1 minute of completion of I&D (Time 2)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age>18 years
Skin abscess in need of incision and drainage (judged by treating physician)
Exclusion Criteria:
Allergy to lidocaine or tetracaine
Non-intact skin
Unable/unwilling to provide informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christina L Bourne, MD
Organizational Affiliation
Medical University of South Carolina
Official's Role
Principal Investigator
12. IPD Sharing Statement
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Injectable Lidocaine Versus Lidocaine/Tetracaine Patch for the Incision and Drainage of Skin Abscesses
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