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

NCT02066818 | Completed Early Phase 1

• 1 other identifier: ECUEM-Synera
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cutaneous Abscess; Pain

Keywords

local anesthetic; incision and drainage; pain; cutaneous abscess

Outcome Measures

Primary Outcomes (1)

• Change in VAS pain score over time

  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)

Study Arms (2)

Lidocaine Injection

ACTIVE COMPARATOR

Incision and drainage performed after patient received placebo patch with injection of 1% lidocaine into the site of the abscess.

Drug: 1% lidocaine

Lidocaine/tetracaine patch

EXPERIMENTAL

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

Interventions

Lidocaine/tetracaine patch DRUG

Also known as: Synera patch

Lidocaine/tetracaine patch

1% lidocaine DRUG

Lidocaine Injection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age\>18 years
• Skin abscess in need of incision and drainage (judged by treating physician)

You may not qualify if:

• Allergy to lidocaine or tetracaine
• Non-intact skin
• Unable/unwilling to provide informed consent

Sponsors & Collaborators

• East Carolina University: lead

MeSH Terms

Conditions

Pain; Surgical Wound

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Christina L Bourne, MD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: November 18, 2013
• First Posted: February 20, 2014
• Study Start: January 1, 2008
• Primary Completion: January 1, 2010
• Study Completion: January 1, 2010
• Last Updated: February 20, 2014

Record last verified: 2014-02