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

Not Applicable

Completed

• Conditions: Burn
• Interventions: Drug: Instilled 1% Lidocaine; Other: Placebo (0.9% Normal Saline)

• Registration Number: NCT00585325
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

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.

Detailed Description

• 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.

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2007-12-26
• Study First Submitted QC: 2008-01-02
• Study First Posted: 2008-01-03
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Results First Submitted: 2017-12-13
• Status Verified: 2018-03
• Results First Submitted QC: 2018-03-05
• Last Update Submitted: 2018-03-05
• Results First Posted: 2018-03-07
• Last Update Posted: 2018-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• all burn service patients with a wound vac

Exclusion Criteria

• allergy to lidocaine

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Instilled 1% Lidocaine	Instilled 1% Lidocaine	5 mg/kg of 1% lidocaine instilled into their VAC sponge ½ hour prior to VAC dressing change
Instilled Placebo (0.9% Normal Saline)	Placebo (0.9% Normal Saline)	receive .9 normal saline instilled into their VAC sponge ½ hour prior to VAC dressing change

Primary Outcome Measures

Name	Time	Method
Pain During Dressing Change	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)

Trial Locations

Locations (1)

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States