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

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ClinicalTrials.gov Identifier: NCT00585325
Recruitment Status : Completed
First Posted : January 3, 2008
Results First Posted : March 7, 2018
Last Update Posted : March 7, 2018
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

December 26, 2007
January 3, 2008
December 13, 2017
March 7, 2018
March 7, 2018
October 2004
November 2008   (Final data collection date for primary outcome measure)
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)
Pain During Dressing Change [ Time Frame: During dressing change ]
Complete list of historical versions of study NCT00585325 on ClinicalTrials.gov Archive Site
Not Provided
There is no secondary outcome measured [ Time Frame: same as primary outcome ]
Not Provided
Not Provided
 
Instilled Lidocaine vs Placebo for Pain Management During Vacuum Assisted Closure (VAC) Dressing Changes
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.

• 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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Burn
  • Drug: Instilled 1% Lidocaine
    5 mg/kg of 1% lidocaine instilled into their VAC sponge ½ hour prior to VAC dressing change
    Other Name: Lidocaine
  • Other: Placebo (0.9% Normal Saline)
    .9 normal saline instilled into their VAC sponge ½ hour prior to VAC dressing change
    Other Name: Normal saline
  • Experimental: Instilled 1% Lidocaine
    5 mg/kg of 1% lidocaine instilled into their VAC sponge ½ hour prior to VAC dressing change
    Intervention: Drug: Instilled 1% Lidocaine
  • Placebo Comparator: Instilled Placebo (0.9% Normal Saline)
    receive .9 normal saline instilled into their VAC sponge ½ hour prior to VAC dressing change
    Intervention: Other: Placebo (0.9% Normal Saline)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
15
80
November 2008
November 2008   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • all burn service patients with a wound vac

Exclusion Criteria:

  • allergy to lidocaine
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00585325
H-2004-0106
No
Not Provided
Not Provided
University of Wisconsin, Madison
University of Wisconsin, Madison
Not Provided
Principal Investigator: Michael J Schurr, MD University of Wisconsin, Madison
University of Wisconsin, Madison
March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP