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

Condition(s) targeted: Burn

Intervention: Lidocaine (Drug); Saline (Other)

Phase: N/A

Status: Recruiting

Sponsored by: University of Wisconsin, Madison

Official(s) and/or principal investigator(s):
Michael J Schurr, MD, Principal Investigator, Affiliation: University of Wisconsin, Madison

Overall contact:
Michael J Schurr, MD, Phone: 608-262-6246, Email: schurr@surgery.wisc.edu

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.

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

Study design: Treatment, Randomized, Single Blind (Investigator), Placebo Control, Single Group Assignment, Efficacy Study

Primary outcome: Pain during dressing change

Secondary outcome: There is no secondary outcome measured

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 shuffeled 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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- all burn service patients with a wound vac

Exclusion Criteria:

- allergy to lidocaine

Michael J Schurr, MD, Phone: 608-262-6246, Email: schurr@surgery.wisc.edu

University of Wisconsin, Madison, Wisconsin 53792, United States; Recruiting
Michael J Schurr, MD, Phone: 608-262-6246, Email: schurr@surgery.wisc.edu

Starting date: October 2004
Last updated: January 2, 2008