Lidocaine Analgesia For Removal Of Wound Vac Dressings - Full Text View

Purpose

The purpose of this prospective study is to compare pain levels in patients with topical negative pressure (TNP) dressings removed in a standard manner (i.v. or p.o. pain meds) compared to dressings removed after normal saline or lidocaine is injected retrograde up the suction tube into the foam prior to removal. Our null hypothesis is that there will be no difference in overall pain scores between the groups receiving saline injection and pain medications or just pain medications, compared to those with lidocaine injection and pain medications. Our objective is to disprove this null hypothesis with statistical significance.

Condition	Intervention
Analgesia	Drug: Lidocaine Drug: Placebo

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Supportive Care
Official Title:	Lidocaine Analgesia For Removal Of Wound Vacuum Assisted Closure Dressings: A Randomized Double Blinded Controlled Trial

Resource links provided by NLM:

Drug Information available for: Lidocaine hydrochloride Lidocaine

U.S. FDA Resources

Further study details as provided by University of Utah:

Primary Outcome Measures:

Visual Analog Scale Pain Score [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Break-through Narcotic Requirement [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Enrollment:	11
Study Start Date:	August 2008
Study Completion Date:	March 2010
Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo Comparator: Saline	Drug: Placebo Control dressing change: iv or po pain medication and injection of 0.9% normal saline retrograde up the suction tube.
Active Comparator: Lidocaine	Drug: Lidocaine Interventional dressing change: iv or po pain medication with injection of 1% lidocaine retrograde up the suction tube into the sponge.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

wounds to which a split-thickness autologous skin graft applied;
infected wounds after debridement;
open fracture wounds;
acute soft-tissue wounds (with exposed tendon, bone, hardware, and/or joint);
fasciotomy wounds after compartment syndrome;
chronic non-healing wounds;
surgical wounds that are difficult to close due to tension; or
wounds with external fixation pins or tubes with irritation or drainage.

Exclusion Criteria:

allergy to lidocaine;
allergy to the polyurethane foam or impermeable seal;
malignancy associated with the wound;
extremity insensate to pain due to any cause (including diabetic neuropathy, or any neurologic disorder therein);
pregnancy as diagnosed by urine pregnancy test.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01126359

Locations

United States, Utah
University of Utah
Salt Lake City, Utah, United States, 84112

Sponsors and Collaborators

University of Utah

Investigators

Principal Investigator:

Erik N Kubiak, MD

University of Utah

More Information

Publications:

Webb LX. New techniques in wound management: vacuum-assisted wound closure. J Am Acad Orthop Surg. 2002 Sep-Oct;10(5):303-11.

Garner GB, Ware DN, Cocanour CS, Duke JH, McKinley BA, Kozar RA, Moore FA. Vacuum-assisted wound closure provides early fascial reapproximation in trauma patients with open abdomens. Am J Surg. 2001 Dec;182(6):630-8.

Choe JH, Kwak KW, Hong JH, Lee HM. Efficacy of lidocaine spray as topical anesthesia for outpatient rigid cystoscopy in women: a prospective, randomized, double-blind trial. Urology. 2008 Apr;71(4):561-6. Epub 2008 Feb 15.

Responsible Party:	University of Utah
ClinicalTrials.gov Identifier:	NCT01126359 History of Changes
Other Study ID Numbers:	29398
Study First Received:	May 17, 2010
Last Updated:	November 1, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Utah:

Wound Vacuum Assisted Dressings
Lidocaine
Dressing change
Pain management
palliative care

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