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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02229578
Acronym
LidocaineBurn
Enrollment
34
Registered
2014-09-01
Start date
2014-09-30
Completion date
2017-11-14
Last updated
2024-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain

Keywords

Burn pain, lidocaine, donor site pain, Narcotic use

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.

Interventions

DRUGLidocaine

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.

DRUGPlacebo

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.

Sponsors

University of Florida
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Pain Change24 hoursImprovement 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.
Pain Change in 24 Hours (Self Reported Pain From Electronic Health Records)Immediate post-op to 24 hours post opPain 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.

Secondary

MeasureTime frameDescription
Change in Hydromorphone in 24 HoursImmediate post-op to 24 hours post opThis 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).

Countries

United States

Participant flow

Participants by arm

ArmCount
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. 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.
16
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. 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.
12
Total28

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyProtocol Violation20
Overall StudyWithdrawal by Subject13

Baseline characteristics

CharacteristicLidocaine Treatment GroupPlacebo Treatment GroupTotal
Age, Continuous43.2 years
STANDARD_DEVIATION 15.1
44.1 years
STANDARD_DEVIATION 14.7
43.7 years
STANDARD_DEVIATION 14.6
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants1 Participants2 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
15 Participants11 Participants26 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Region of Enrollment
United States
16 participants12 participants28 participants
Sex: Female, Male
Female
5 Participants1 Participants6 Participants
Sex: Female, Male
Male
11 Participants11 Participants22 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 160 / 12
other
Total, other adverse events
5 / 163 / 12
serious
Total, serious adverse events
5 / 162 / 12

Outcome results

Primary

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

ArmMeasureValue (MEAN)
Lidocaine Treatment GroupPain Change-3.8 units on a scale
Placebo Treatment GroupPain Change-4.0 units on a scale
Comparison: Outcome was residual change score calculated by regressing immediate postop pain on 24 hour pain. This allows patient to serve as own control for intial values.p-value: <0.0595% CI: [-1.2, 2.1]t-test, 2 sided
Primary

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

Population: This was an intention to treat analysis. Pain was measured with self reported pain from electronic health records and improvement was change from immediate post-op to 24 hours post-op (pain at 24 hours minus pain immediate postop) Assessment

ArmMeasureValue (MEAN)
Lidocaine Treatment GroupPain Change in 24 Hours (Self Reported Pain From Electronic Health Records)-2.1 units on a scale
Placebo Treatment GroupPain Change in 24 Hours (Self Reported Pain From Electronic Health Records)-4.0 units on a scale
Comparison: Outcome was residual change score calculated by regressing immediate postop pain on 24 hour pain. This allows patient to serve as own control for intial values.p-value: <0.0595% CI: [-1.77, 1.49]t-test, 2 sided
Secondary

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

Population: 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. There were n=3 in lidocaine group with no medication doses reported.

ArmMeasureValue (MEAN)
Lidocaine Treatment GroupChange in Hydromorphone in 24 Hours0.4 milligram morphine equivalents (MME)
Placebo Treatment GroupChange in Hydromorphone in 24 Hours4.7 milligram morphine equivalents (MME)
Comparison: Outcome was residual change score calculated by regressing immediate postop hydromorphone on 24 hour hydromorphone. This allows patient to serve as own control for intial values.p-value: <0.0595% CI: [-9.62, 6.09]t-test, 2 sided

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026