Lidocaine Analgesia For Removal Of Wound Vac Dressings

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eric Kubiak, University of Utah
ClinicalTrials.gov Identifier:
NCT01126359
First received: May 17, 2010
Last updated: May 21, 2014
Last verified: May 2014
  Purpose

The purpose of this prospective study is to compare pain levels and pain medication dose requirements in patients with topical negative pressure (TNP) dressings removed in a standard manner (i.v. or p.o. pain meds) compared to dressings removed with lidocaine analgesia, via injection 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 or medication requirements when patients receive a saline, control injection and pain medications, compared to when their dressings are changed with a lidocaine injection into the sponge, with pain medications. Our objective is to disprove this null hypothesis with statistical significance.


Condition Intervention
Pain
Drug: Lidocaine
Drug: Placebo-Saline

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:


Further study details as provided by University of Utah:

Primary Outcome Measures:
  • Visual Analog Scale Pain Score [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]
    Visial Analog Pain Scores (VAS) range from 0 (no pain) - 10 (worst pain ever). Visial Analog Pain Scores are determined at each pain measurement time point (during/after VAC dressing removal).


Secondary Outcome Measures:
  • Break-through Narcotic Requirement [ Time Frame: 20 minutes ] [ Designated as safety issue: No ]
    Patient break-through narcotic requirements in morphine equivalents are 0.2 mg of dilaudid = 1 mg of morphine, iv., used during and after VAC dressing change.


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

  Eligibility

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

Inclusion Criteria:

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

Exclusion Criteria:

  1. allergy to lidocaine;
  2. allergy to the polyurethane foam or impermeable seal;
  3. malignancy associated with the wound;
  4. extremity insensate to pain due to any cause (including diabetic neuropathy, or any neurologic disorder therein);
  5. pregnancy as diagnosed by urine pregnancy test.
  Contacts and Locations
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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:
Responsible Party: Eric Kubiak, M.D., University of Utah
ClinicalTrials.gov Identifier: NCT01126359     History of Changes
Other Study ID Numbers: 29398
Study First Received: May 17, 2010
Results First Received: January 22, 2013
Last Updated: May 21, 2014
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 July 24, 2014