Lidocaine Analgesia For Removal Of Wound Vacuum Assisted Closure Dressings: A Randomized Double Blinded Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Lidocaine
- Conditions
- Pain
- Sponsor
- University of Utah
- Enrollment
- 11
- Locations
- 1
- Primary Endpoint
- Visual Analog Scale Pain Score
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
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.
Investigators
Eric Kubiak
M.D.
University of Utah
Eligibility 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.
Arms & Interventions
Lidocaine then Placebo-Saline
Intervention: Lidocaine
Lidocaine then Placebo-Saline
Intervention: Placebo-Saline
Placebo-Saline then Lidocaine
Intervention: Lidocaine
Placebo-Saline then Lidocaine
Intervention: Placebo-Saline
Outcomes
Primary Outcomes
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).
Secondary Outcomes
- Break-through Narcotic Requirement(20 minutes)