Injectable Lidocaine Versus Lidocaine/Tetracaine Patch for the Incision and Drainage of Skin Abscesses

February 18, 2014 updated by: Christina L. Bourne, East Carolina University

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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Early Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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.
Drug: 1% lidocaine
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
Drug: Lidocaine/tetracaine patch
Other Names:
  • Synera patch

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

This is where you will find people and organizations involved with this study.

Sponsor

East Carolina University

Investigators

  • Principal Investigator: Christina L Bourne, MD, Medical University of South Carolina

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2008

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

November 18, 2013

First Submitted That Met QC Criteria

February 18, 2014

First Posted (Estimate)

February 20, 2014

Study Record Updates

Last Update Posted (Estimate)

February 20, 2014

Last Update Submitted That Met QC Criteria

February 18, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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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