Lidocaine Analgesia For Removal Of Wound Vac Dressings

Not Applicable

Completed

• Conditions: Pain
• Interventions: Drug: Lidocaine; Drug: Placebo-Saline

• Registration Number: NCT01126359
• Lead Sponsor: University of Utah

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Study First Submitted: 2010-05-17
• Study First Submitted QC: 2010-05-18
• Study First Posted: 2010-05-19
• Results First Submitted: 2013-01-22
• Status Verified: 2014-05
• Results First Submitted QC: 2014-05-21
• Last Update Submitted: 2014-05-21
• Results First Posted: 2014-05-29
• Last Update Posted: 2014-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Lidocaine then Placebo-Saline	Placebo-Saline	-
Placebo-Saline then Lidocaine	Placebo-Saline	-
Placebo-Saline then Lidocaine	Lidocaine	-
Lidocaine then Placebo-Saline	Lidocaine	-

Primary Outcome Measures

Name	Time	Method
Visual Analog Scale Pain Score	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 Outcome Measures

Name	Time	Method
Break-through Narcotic Requirement	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.

Trial Locations

Locations (1)

University of Utah; 🇺🇸 Salt Lake City, Utah, United States