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

NCT ID: NCT00585325

Last Updated: 2018-03-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2008-11-30

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.

Conditions

Burn

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Instilled 1% Lidocaine

5 mg/kg of 1% lidocaine instilled into their VAC sponge ½ hour prior to VAC dressing change

Group Type: EXPERIMENTAL

Instilled 1% Lidocaine

Intervention Type: DRUG

5 mg/kg of 1% lidocaine instilled into their VAC sponge ½ hour prior to VAC dressing change

Instilled Placebo (0.9% Normal Saline)

receive .9 normal saline instilled into their VAC sponge ½ hour prior to VAC dressing change

Group Type: PLACEBO_COMPARATOR

Placebo (0.9% Normal Saline)

Intervention Type: OTHER

.9 normal saline instilled into their VAC sponge ½ hour prior to VAC dressing change

Interventions

Instilled 1% Lidocaine

5 mg/kg of 1% lidocaine instilled into their VAC sponge ½ hour prior to VAC dressing change

Intervention Type: DRUG

Placebo (0.9% Normal Saline)

.9 normal saline instilled into their VAC sponge ½ hour prior to VAC dressing change

Intervention Type: OTHER

Other Intervention Names

Lidocaine; Normal saline

Eligibility Criteria

Inclusion Criteria

• all burn service patients with a wound vac

Exclusion Criteria

• allergy to lidocaine

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Wisconsin, Madison

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael J Schurr, MD

Role: PRINCIPAL_INVESTIGATOR

University of Wisconsin, Madison

Locations

University of Wisconsin

Madison, Wisconsin, United States

Countries

United States

Other Identifiers

H-2004-0106

Identifier Type: -

Identifier Source: org_study_id