Clinical trial NCT01126359: Lidocaine Analgesia For Removal Of Wound Vac Dressings
Official title: Lidocaine Analgesia For Removal Of Wound Vacuum Assisted Closure Dressings: A Randomized Double Blinded Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Wound Vacuum Assisted Dressings
Lidocaine
Dressing change
Pain management
palliative care
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2010-05-19
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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.

Primary outcomes:
measure: Visual Analog Scale Pain Score
timeFrame: 20 minutes
Secondary outcomes:
measure: Break-through Narcotic Requirement
timeFrame: 20 minutes
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
Study officials:
affiliation: University of Utah
name: Erik N Kubiak, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Webb LX. New techniques in wound management: vacuum-assisted wound closure. J Am Acad Orthop Surg. 2002 Sep-Oct;10(5):303-11. doi: 10.5435/00124635-200209000-00002.
citation: 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. doi: 10.1016/s0002-9610(01)00786-3.
citation: 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.
citation: Christensen TJ, Thorum T, Kubiak EN. Lidocaine analgesia for removal of wound vacuum-assisted closure dressings: a randomized double-blinded placebo-controlled trial. J Orthop Trauma. 2013 Feb;27(2):107-12. doi: 10.1097/BOT.0b013e318251219c.