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Lidocaine Analgesia For Removal Of Wound Vac Dressings

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01126359
First Posted: May 19, 2010
Last Update Posted: May 29, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Eric Kubiak, University of Utah
May 17, 2010
May 19, 2010
January 22, 2013
May 29, 2014
May 29, 2014
August 2008
March 2010   (Final data collection date for primary outcome measure)
Visual Analog Scale Pain Score [ Time Frame: 20 minutes ]
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).
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Complete list of historical versions of study NCT01126359 on ClinicalTrials.gov Archive Site
Break-through Narcotic Requirement [ Time Frame: 20 minutes ]
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.
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Lidocaine Analgesia For Removal Of Wound Vac Dressings
Lidocaine Analgesia For Removal Of Wound Vacuum Assisted Closure Dressings: A Randomized Double Blinded Controlled Trial
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.
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Interventional
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Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Supportive Care
Pain
  • 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
  • Placebo Comparator: Lidocaine then Placebo-Saline
    Interventions:
    • Drug: Lidocaine
    • Drug: Placebo-Saline
  • Active Comparator: Placebo-Saline then Lidocaine
    Interventions:
    • Drug: Lidocaine
    • Drug: Placebo-Saline

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
March 2010
March 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01126359
29398
No
Not Provided
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Eric Kubiak, University of Utah
University of Utah
Not Provided
Principal Investigator: Erik N Kubiak, MD University of Utah
University of Utah
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP