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

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Lidocaine; Drug: Placebo

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32601
      • Shands Hospital, University of Florida
    • Gainesville, Florida, United States, 32603
      • Shands Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Study Population

Patient accessing burn treatment services at an area hospital.

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lidocaine Treatment Group; Subjects in this group will receive a nonpyrogenic solution of lidocaine 2% in isotonic saline (Solution A) sprayed on the donor site of the grafted skin prior to emergence from general anesthesia. A total maximum of 7mg/kg of lidocaine solution will be available for administration. Prior to spraying of the Solution A, the donor site will be soaked with epinephrine soaked towels as per routine burn care. The site will then be covered with TheraBond dressing as per standard burn care.	Drug: Lidocaine; Subjects in this group will receive a nonpyrogenic solution of lidocaine 2% in isotonic saline (Solution A) sprayed on the donor site of the grafted skin prior to emergence from general anesthesia. A total maximum of 7mg/kg of lidocaine solution will be available for administration. Prior to spraying of the Solution A, the donor site will be soaked with epinephrine soaked towels as per routine burn care. The site will then be covered with TheraBond dressing as per standard burn care.
Placebo Comparator: Placebo Treatment Group; Subjects in this group will receive a nonpyrogenic solution of isotonic saline (Solution B) sprayed over the donor site. Prior to spraying of the Solution B, the donor site will be soaked with epinephrine soaked towels as per routine burn care. The site will then be covered with TheraBond dressing as per standard burn care.	Drug: Placebo; Subjects in this group will receive a nonpyrogenic solution of isotonic saline (Solution B) sprayed over the donor site. Prior to spraying of the Solution B, the donor site will be soaked with epinephrine soaked towels as per routine burn care. The site will then be covered with TheraBond dressing as per standard burn care.; Other Names: Saline

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain Change	Improvement of pain perception for those receiving lidocaine vs those that do not. Pain will be measured by the Verbal Numerical Rating Scale (VNRS). This scale ranges from 0 to 10, with 0 being no pain and 10 being worst pain.	24 hours
Pain Change in 24 Hours (Self Reported Pain From Electronic Health Records)	Pain will be measured by the Verbal Numerical Rating Scale (VNRS). This scale ranges from 0 to 10, with 0 being no pain and 10 being worst pain.	Immediate post-op to 24 hours post op

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hydromorphone in 24 Hours	This was an intention to treat analysis. records and improvement was change from immediate post-op to 24 hours post-op (pain at 24 hours minus pain immediate postop) Assessment. Hydromorphone was quantified as morphine milligram equivelents (MME).	Immediate post-op to 24 hours post op

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Brenda Fahy, MD, University of Florida

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2014
• Primary Completion (Actual): November 14, 2017
• Study Completion (Actual): November 14, 2017

Study Registration Dates

• First Submitted: August 27, 2014
• First Submitted That Met QC Criteria: August 29, 2014
• First Posted (Estimated): September 1, 2014

Study Record Updates

• Last Update Posted (Actual): July 1, 2024
• Last Update Submitted That Met QC Criteria: June 27, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: lidocaine; Burn pain; donor site pain; Narcotic use
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: IRB201400019; OCR18920 (Other Identifier: UF OnCore)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No