Lidocaine Analgesia For Removal Of Wound Vac Dressings
Information source: University of Utah
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: Lidocaine (Drug); Placebo-Saline (Drug)
Phase: N/A
Status: Completed
Sponsored by: University of Utah Official(s) and/or principal investigator(s):
Erik N Kubiak, MD, Principal Investigator, Affiliation: University of Utah
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.
Clinical Details
Official title: Lidocaine Analgesia For Removal Of Wound Vacuum Assisted Closure Dressings: A Randomized Double Blinded Controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care
Primary outcome: Visual Analog Scale Pain Score
Secondary outcome: Break-through Narcotic Requirement
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
University of Utah, Salt Lake City, Utah 84112, United States
Additional Information
Related publications: Webb LX. New techniques in wound management: vacuum-assisted wound closure. J Am Acad Orthop Surg. 2002 Sep-Oct;10(5):303-11. Garner GB, Ware DN, Cocanour CS, Duke JH, McKinley BA, Kozar RA, Moore FA. Vacuum-assisted wound closure provides early fascial reapproximation in trauma patients with open abdomens. Am J Surg. 2001 Dec;182(6):630-8. Choe JH, Kwak KW, Hong JH, Lee HM. Efficacy of lidocaine spray as topical anesthesia for outpatient rigid cystoscopy in women: a prospective, randomized, double-blind trial. Urology. 2008 Apr;71(4):561-6. doi: 10.1016/j.urology.2007.11.057. Epub 2008 Feb 15.
Starting date: August 2008
Last updated: May 21, 2014
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