Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02229578
Recruitment Status : Recruiting
First Posted : September 1, 2014
Last Update Posted : May 21, 2019
Sponsor:
Information provided by (Responsible Party):
University of Florida

Tracking Information
First Submitted Date August 27, 2014
First Posted Date September 1, 2014
Last Update Posted Date May 21, 2019
Study Start Date September 2014
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 29, 2014)
Pain improvement [ Time Frame: 24 hours ]
Improvement of pain perception for those receiving lidocaine vs those that do not using reported pain scale (zero through ten). The amount of narcotics utilized will also documented and compared between groups.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02229578 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Lidocaine For Treatment of Post-operative Pain From Donor Sites Following Burn Injury.
Official Title Lidocaine In The Treatment of Post-operative Pain Management From a Donor Site After Split Thickness Skin Graft Harvesting Following Thermal Injury
Brief Summary 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.
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 Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patient accessing burn treatment services at an area hospital.
Condition Pain
Intervention
  • 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.
  • 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 Name: Saline
Study Groups/Cohorts
  • 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.
    Intervention: Drug: Lidocaine
  • 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.
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: April 5, 2018)
60
Original Estimated Enrollment
 (submitted: August 29, 2014)
50
Estimated Study Completion Date May 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Tera Thigpin, MS 352-246-9064 tera.thigpin@surgery.ufl.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02229578
Other Study ID Numbers IRB201400019
OCR18920 ( Other Identifier: UF OnCore )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Florida
Study Sponsor University of Florida
Collaborators Not Provided
Investigators
Principal Investigator: Brenda Fahy, MD University of Florida
PRS Account University of Florida
Verification Date May 2019