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Completed

NCT Number: NCT00585325

Instilled Lidocaine vs Placebo for Pain Management During Vacuum Assisted Closure (VAC) Dressing Changes

Patients will be randomized prospectively to one of two groups. One group will receive 5 mg/kg of 1% lidocaine, and the other will receive .9 normal saline, instilled into their VAC sponge ½ hour prior to VAC dressing change. All patients will complete a pain assessment tool prior to receiving the instilled lidocaine/placebo, immediately after the procedure and 1 hour after the procedure. Pain scores will then be compared between the lidocaine and placebo groups.

Risks: Lidocaine toxicity is a potential risk, but 5 mg/kg of 1 % Lidocaine is below toxicity thresholds in an adult.

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Key information

Conditions

Burn Burns Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Wisconsin

Madison, Wisconsin, 53792, United States

About this study

  • All Burn service patients (inpatients and outpatients in burn clinic) who are receiving VAC therapy will be screened for study inclusion criteria. Those with allergies to lidocaine will be excluded. Participants will be enrolled until a sample size of 80 wound VAC changes is achieved. Up to 4 VAC dressing changes can be included in this study per participant. Subjects will be randomized prospectively for each dressing change. Utilizing a randomized bracketed approach, patients will be assigned to one of two groups: Lidocaine group or Placebo group. The Pharmacy Research Center (PRC) will assign patient a study Identification (ID) number and record it along with their medical record number on the Master Study ID List. They will then randomize the participants by drawing randomly shuffled green vs white index cards. (40 white card = 0.9 normal saline and 40 green card = 5 mg/kg of 1% Lidocaine). They will draw up the appropriate amount of medication to be used, label it with the patients Medical Record (MR) #, date, and administration instructions and deliver it to the nurse who is doing the VAC dressing change. They will keep the Master Randomization Data Collection Tool in a locked drawer in her office.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • all burn service patients with a wound vac

Exclusion criteria

  • allergy to lidocaine

Treatment and study plan

Instilled 1% Lidocaine

Drug

5 mg/kg of 1% lidocaine instilled into their VAC sponge ½ hour prior to VAC dressing change

Other names: Lidocaine

Placebo (0.9% normal saline)

Other

.9 normal saline instilled into their VAC sponge ½ hour prior to VAC dressing change

Other names: Normal saline

Primary outcomes

  1. Pain During Dressing Change

    Time frame: During dressing change

    A pain assessment tool performed immediately after the dressing change was used to rate pain experienced during the dressing change. For this tool, pain was rated on a scale from 0-10 (0=no pain and 10=worst possible pain)

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

Instilled Lidocaine vs Placebo for Pain Management During Vacuum Assisted Closure (VAC) Dressing Changes.

Important dates

Study start
2004
Primary completion
2008
Study completion
2008
First posted
Jan 3, 2008
Registry last updated
Mar 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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