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

This study has been completed.
Sponsor:
Information provided by:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00585325
First received: December 26, 2007
Last updated: August 4, 2011
Last verified: August 2011
History of Changes
  Purpose

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 Intervention
Burn
 Drug: Instilled 1% Lidocaine
Other: Placebo (0.9% Normal Saline)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Instilled Lidocaine vs Placebo for Pain Management During Vacuum Assisted Closure (VAC) Dressing Changes.

Resource links provided by NLM:

MedlinePlus related topics: Burns
U.S. FDA Resources

Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Pain during dressing change [ Time Frame: During dressing change ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • There is no secondary outcome measured [ Time Frame: same as primary outcome ] [ Designated as safety issue: No ]

Enrollment: 11
Study Start Date: October 2004
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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 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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • all burn service patients with a wound vac

Exclusion Criteria:

  • allergy to lidocaine
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: Michael J. Schurr, University of Wisconsin
ClinicalTrials.gov Identifier: NCT00585325     History of Changes
Other Study ID Numbers: H-2004-0106
Study First Received: December 26, 2007
Last Updated: August 4, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
 Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 18, 2013