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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
East Carolina University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    November 18, 2013
    Last Updated
    February 18, 2014
    Sponsor
    East Carolina University
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    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

    Learn more about this trial

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

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