- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02066818
Injectable Lidocaine Versus Lidocaine/Tetracaine Patch for the Incision and Drainage of Skin Abscesses
Injectable Lidocaine Provides Similar Analgesia Compared to Transdermal Lidocaine/Tetracaine Patch for the Incision and Drainage of Skin Abscesses: A Randomized Controlled Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Early Phase 1
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Lidocaine Injection
Incision and drainage performed after patient received placebo patch with injection of 1% lidocaine into the site of the abscess.
|
|
Experimental: Lidocaine/tetracaine patch
Incision and drainage performed after patient received active lidocaine/tetracaine patch and injection of 10cc of saline into site of abscess
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in VAS pain score over time
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)
|
VAS measured at each of the 3 time points noted above.
|
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)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Christina L Bourne, MD, Medical University of South Carolina
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Infections
- Inflammation
- Suppuration
- Abscess
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Sensory System Agents
- Anesthetics
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
- Tetracaine
Other Study ID Numbers
- ECUEM-Synera
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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