Lidocaine Analgesia For Removal Of Wound Vac Dressings

May 21, 2014 updated by: Eric Kubiak, University of Utah

Lidocaine Analgesia For Removal Of Wound Vacuum Assisted Closure Dressings: A Randomized Double Blinded Controlled Trial

The purpose of this prospective study is to compare pain levels and pain medication dose requirements in patients with topical negative pressure (TNP) dressings removed in a standard manner (i.v. or p.o. pain meds) compared to dressings removed with lidocaine analgesia, via injection retrograde up the suction tube into the foam prior to removal. Our null hypothesis is that there will be no difference in overall pain scores or medication requirements when patients receive a saline, control injection and pain medications, compared to when their dressings are changed with a lidocaine injection into the sponge, with pain medications. Our objective is to disprove this null hypothesis with statistical significance.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • University of Utah

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. wounds to which a split-thickness autologous skin graft applied;
  2. infected wounds after debridement;
  3. open fracture wounds;
  4. acute soft-tissue wounds (with exposed tendon, bone, hardware, and/or joint);
  5. fasciotomy wounds after compartment syndrome;
  6. chronic non-healing wounds;
  7. surgical wounds that are difficult to close due to tension; or
  8. wounds with external fixation pins or tubes with irritation or drainage.

Exclusion Criteria:

  1. allergy to lidocaine;
  2. allergy to the polyurethane foam or impermeable seal;
  3. malignancy associated with the wound;
  4. extremity insensate to pain due to any cause (including diabetic neuropathy, or any neurologic disorder therein);
  5. pregnancy as diagnosed by urine pregnancy test.

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: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Lidocaine then Placebo-Saline
Drug: Lidocaine
Interventional dressing change: iv or po pain medication with injection of 1% lidocaine retrograde up the suction tube into the sponge.
Other Names:
  • xylocaine
Drug: Placebo-Saline
Control dressing change: iv or po pain medication and injection of 0.9% normal saline retrograde up the suction tube.
Other Names:
  • 0.9% normal saline
Active Comparator: Placebo-Saline then Lidocaine
Drug: Lidocaine
Interventional dressing change: iv or po pain medication with injection of 1% lidocaine retrograde up the suction tube into the sponge.
Other Names:
  • xylocaine
Drug: Placebo-Saline
Control dressing change: iv or po pain medication and injection of 0.9% normal saline retrograde up the suction tube.
Other Names:
  • 0.9% normal saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Scale Pain Score
Time Frame: 20 minutes
Visial Analog Pain Scores (VAS) range from 0 (no pain) - 10 (worst pain ever). Visial Analog Pain Scores are determined at each pain measurement time point (during/after VAC dressing removal).
20 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Break-through Narcotic Requirement
Time Frame: 20 minutes
Patient break-through narcotic requirements in morphine equivalents are 0.2 mg of dilaudid = 1 mg of morphine, iv., used during and after VAC dressing change.
20 minutes

Collaborators and Investigators

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

Sponsor

University of Utah

Investigators

  • Principal Investigator: Erik N Kubiak, MD, University of Utah

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2008

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

May 17, 2010

First Submitted That Met QC Criteria

May 18, 2010

First Posted (Estimate)

May 19, 2010

Study Record Updates

Last Update Posted (Estimate)

May 29, 2014

Last Update Submitted That Met QC Criteria

May 21, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 29398

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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