Lidocaine Analgesia For Removal Of Wound Vac Dressings

Study Overview
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Brief Summary
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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.

Official Title
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Lidocaine Analgesia For Removal Of Wound Vacuum Assisted Closure Dressings: A Randomized Double Blinded Controlled Trial

Conditions
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Pain

Intervention / Treatment
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* Drug: Lidocaine
* Drug: Placebo-Saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Lidocaine then Placebo-Saline<br> | Drug: Lidocaine<br>* Interventional dressing change: iv or po pain medication with injection of 1% lidocaine retrograde up the suction tube into the sponge.<br>* Other names: xylocaine;Drug: Placebo-Saline<br>* Control dressing change: iv or po pain medication and injection of 0.9% normal saline retrograde up the suction tube.<br>* Other names: 0.9% normal saline;|
| Active Comparator: Placebo-Saline then Lidocaine<br> | Drug: Lidocaine<br>* Interventional dressing change: iv or po pain medication with injection of 1% lidocaine retrograde up the suction tube into the sponge.<br>* Other names: xylocaine;Drug: Placebo-Saline<br>* Control dressing change: iv or po pain medication and injection of 0.9% normal saline retrograde up the suction tube.<br>* Other names: 0.9% normal saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale Pain Score | 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). | 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Break-through Narcotic Requirement | 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. | 20 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Wound Vacuum Assisted Dressings, Lidocaine, Dressing change, Pain management, palliative care