Lidocaine For Treatment of Post-operative Pain From Donor Sites Following Burn Injury.



Status:Recruiting
Conditions:Chronic Pain, Post-Surgical Pain
Therapuetic Areas:Musculoskeletal
Healthy:No
Age Range:18 - Any
Updated:1/9/2019
Start Date:September 2014
End Date:May 2019
Contact:Tera Thigpin, MS
Email:tera.thigpin@surgery.ufl.edu
Phone:352-246-9064

Use our guide to learn which trials are right for you!

Lidocaine In The Treatment of Post-operative Pain Management From a Donor Site After Split Thickness Skin Graft Harvesting Following Thermal Injury

Burn pain is known to be one the most severe forms of acute pain often requiring large
amounts of narcotics in addition to other adjuvants. Topical lidocaine is effective for
controlling pain in various settings including dressing changes of burns. The aim of this
study is to demonstrate the effectiveness of topical lidocaine in decreasing pain scores and
narcotic requirements when applied to donor graft sites while at the same time not
interfering with the standard of care TheraBond dressing. During this study the investiagtors
will be monitoring for evidence of delayed wound healing, and surgical site infection.

Pain from burns is a severe form of acute pain that requires aggressive use of opioids. Even
with the implementation of multiple modalities for analgesia, pain from skin debridements and
grafting procedures remains a challenge to control. Local anesthetics have been used for pain
relief in burn patients previously as a topical gel or IV infusion and have been found to
significantly reduce medication consumption, without apparent adverse effects on wound
healing. Lidocaine actually has potent anti-inflammatory effects which could be advantageous
on wounds. In addition, topical application of lidocaine to wounds result in different
degrees of systemic absorption. High concentrations of lidocaine have potential for central
nervous system (seizures (>5mg/L)) and cardiovascular toxicity (arrhythmias (>9mg/L)). Plasma
concentration of lidocaine depend upon drug dose, rate of absorption, patient weight,
physical status and thickness of skin harvested. A prior study where up to 6.7mg/kg of 2%
lidocaine with epinephrine was sprayed on donor graft sites found that systemic lidocaine
levels were far below toxic levels at their peak (average level of 1.4, with maximum level at
2.2). In this study the levels peaked between 30 and 60 minutes and systemic levels of
lidocaine were detectable 6 hours following application of the solution. Studies have
demonstrated the beneficial effects of systemic lidocaine administered via IV infusions in
reducing perioperative pain scores.Topical lidocaine is effective as a topical anesthetic in
multiple clinical trials however only two studies to date has shown that topical lidocaine
applied to skin-harvest sites produces an analgesic effect, reduces narcotic requirements
while not affecting wound healing or causing toxic blood concentrations. In both these
studies systemic intravenous lidocaine levels were monitored and were found to be
significantly below toxic limits. The use of topical lidocaine on donor sites is still not
widely used, partly for fear the lidocaine will interfere with wound healing and/or dressing
adherence. No study to date has demonstrated lidocaine solution to be effective on burn sites
when used in conjunction with TheraBond silver foam dressing. TheraBond is an absorbent,
atraumatic dressing coated with ionic silver that is routinely used on donor sites at the
University of Florida. This study will also offer additional supporting evidence that topical
lidocaine is effective in post operative pain management of donor skin sites and should be
more widely utilized. In addition, this study will serve as a stepping stone for analyzing
different local anesthetic solutions in the future and the potential for reapplication to
surgical sites.

The purpose of this study is to offer the medical community data on a simple and relatively
cheap adjuvant that can be utilized to help reduce the amount of post-operative pain and
narcotic requirement in burn patients requiring skin grafts.

Inclusion Criteria:

- Adult patients who have suffered second to third degree burns requiring a single split
thickness skin graft surgery.

- Donor sites will be between 3-15% TBSA.

Exclusion Criteria:

- Patients who have history of chronic pain,

- opioid abuse history,

- major renal and/or liver dysfunction,

- history of seizures or major neurologic deficiencies,

- allergy to local anesthetics,

- reported allergy to hydromorphone,

- pregnancy, or

- currently have other injuries that significantly contribute to pain (i.e. multi-trauma
patients) will be excluded from the study.
We found this trial at
2
sites
Gainesville, Florida 32610
Phone: 352-273-8298
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
Gainesville, Florida 32610
Principal Investigator: Brenda Fahy, MD
?
mi
from
Gainesville, FL
Click here to add this to my saved trials