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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

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.


Condition or disease Intervention/treatment Phase
Burn Drug: Instilled 1% Lidocaine Other: Placebo (0.9% Normal Saline) Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Instilled Lidocaine vs Placebo for Pain Management During Vacuum Assisted Closure (VAC) Dressing Changes.
Study Start Date : October 2004
Actual Primary Completion Date : November 2008
Actual Study Completion Date : November 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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



Primary Outcome Measures :
  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)



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • all burn service patients with a wound vac

Exclusion Criteria:

  • allergy to lidocaine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00585325


Locations
United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Michael J Schurr, MD University of Wisconsin, Madison

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00585325     History of Changes
Other Study ID Numbers: H-2004-0106
First Posted: January 3, 2008    Key Record Dates
Results First Posted: March 7, 2018
Last Update Posted: March 7, 2018
Last Verified: March 2018

Additional relevant MeSH terms:
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action