A Phase 4 interventional study of Lidocaine and Placebo in Pain, sponsored by University of Florida. Completed at 2 sites in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-01.
Sponsored by University of Florida · Phase 4, Interventional, and Treatment
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.
2,450 studies on the registry are indexed under Pain; 945 are open to participants now.
This study's enrollment of 34 is below the median of 70 across 2,101 interventional studies indexed under Pain.
Browse Pain studies →University of Florida is the lead sponsor of 1,285 studies on the registry; 199 are open to participants now.
Of its 177 completed or terminated interventional studies of FDA-regulated products, 141 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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 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 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.
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.
Also known as: Saline
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.
Time frame: 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.
Time frame: Immediate post-op to 24 hours post op
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).
Time frame: Immediate post-op to 24 hours post op
| Milestone | Lidocaine Treatment Group | Placebo Treatment Group |
|---|---|---|
| Started | 19 | 15 |
| Completed | 16 | 12 |
| Not completed | 3 | 3 |
| Withdrew: Withdrawal by subject | 1 | 3 |
| Withdrew: Protocol violation | 2 | 0 |
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.
| units on a scale | Lidocaine Treatment Group | Placebo Treatment Group |
|---|---|---|
| Pain Change | -3.8 (-5.3 to -2.2) | -4.0 (-5.5 to -2.5) |
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.
| units on a scale | Lidocaine Treatment Group | Placebo Treatment Group |
|---|---|---|
| Pain Change in 24 Hours (Self Reported Pain From Electronic Health Records) | -2.1 (-4.6 to -0.5) | -4.0 (-5.1 to -2.9) |
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).
| milligram morphine equivalents (MME) | Lidocaine Treatment Group | Placebo Treatment Group |
|---|---|---|
| Change in Hydromorphone in 24 Hours | 0.4 (-0.4 to 1.3) | 4.7 (-3.4 to 12.9) |
Collected over 21 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Lidocaine Treatment Group | 0/16 (0%) | 5/16 (31.3%) | 5/16 (31.3%) |
| Placebo Treatment Group | 0/12 (0%) | 2/12 (16.7%) | 3/12 (25%) |
| Event | Lidocaine Treatment Group | Placebo Treatment Group |
|---|---|---|
| Infection at donor siteInfections and infestations | 5/16 | 2/12 |
| Event | Lidocaine Treatment Group | Placebo Treatment Group |
|---|---|---|
| Acute lood loss AnemiaBlood and lymphatic system disorders | 2/16 | 1/12 |
| Graft failureSkin and subcutaneous tissue disorders | 1/16 | 1/12 |
| Prolongation of hospitalizationInvestigations | 0/16 | 1/12 |
| Wound breakdownSkin and subcutaneous tissue disorders | 1/16 | 0/12 |
| Acute kidney injuryRenal and urinary disorders | 1/16 | 0/12 |
| Age, Continuous(years) | Lidocaine Treatment Group | Placebo Treatment Group | Total |
|---|---|---|---|
| Mean | 43.2 ± 15.1 | 44.1 ± 14.7 | 43.7 ± 14.6 |
| Sex: Female, Male(Participants) | Lidocaine Treatment Group | Placebo Treatment Group | Total |
|---|---|---|---|
| Female | 5 | 1 | 6 |
| Male | 11 | 11 | 22 |
| Ethnicity (NIH/OMB)(Participants) | Lidocaine Treatment Group | Placebo Treatment Group | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 1 | 2 |
| Not Hispanic or Latino | 15 | 11 | 26 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Lidocaine Treatment Group | Placebo Treatment Group | Total |
|---|---|---|---|
| United States | 16 | 12 | 28 |
Documents are hosted by the registry — open the source record to download them.
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Lidocaine