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

NCT00585325 | Completed Results

• 1 other identifier: H-2004-0106
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Burn

Outcome Measures

Primary Outcomes (1)

• Pain 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)

  During dressing change

Study Arms (2)

Instilled 1% Lidocaine

EXPERIMENTAL

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

Drug: Instilled 1% Lidocaine

Instilled Placebo (0.9% Normal Saline)

PLACEBO COMPARATOR

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

Other: Placebo (0.9% Normal Saline)

Interventions

Instilled 1% Lidocaine DRUG

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

Also known as: Lidocaine

Instilled 1% Lidocaine

Placebo (0.9% Normal Saline) OTHER

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

Also known as: Normal saline

Instilled Placebo (0.9% Normal Saline)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all burn service patients with a wound vac

You may not qualify if:

• allergy to lidocaine

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Burns

Interventions

Lidocaine; Saline Solution

Condition Hierarchy (Ancestors)

Wounds and Injuries

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Results Point of Contact

• Title: Cindy Schmitz, RN, MS, NP
• Organization: University of Wisconsin-Madison

CSchmitz@uwhealth.org

608-262-2664

Study Officials

• Michael J Schurr, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: January 3, 2008
• Study Start: October 1, 2004
• Primary Completion: November 1, 2008
• Study Completion: November 1, 2008
• Last Updated: March 7, 2018
• Results First Posted: March 7, 2018

Record last verified: 2018-03

Locations

US (1)