N/A
N=11
Lidocaine Analgesia For Removal Of Wound Vac Dressings
Pain
Bottom Line
View on ClinicalTrials.gov: NCT01126359 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
May 2014
Primary outcome: Primary: Visual Analog Scale Pain Score — 6.5; 8.9; -2.4; 4.4 Visial Analog Pain Score (VAS)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Lidocaine (Drug); Placebo-Saline (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Utah
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Analog Scale Pain Score |
6.5; 8.9; -2.4; 4.4; 6.4; -2.0 | — |
| SECONDARY Break-through Narcotic Requirement |
1.3; 3.0; -1.7; 0.8; 1.1; -0.4 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01126359). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.