Trial Outcomes & Findings for Lidocaine For Treatment of Post-operative Pain From Donor Sites Following Burn Injury. (NCT NCT02229578)

NCT ID: NCT02229578

Last Updated: 2024-07-01

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 34 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2024-07-01

Participant Flow

Participant milestones

Measure	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.	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.
Overall Study STARTED	19	15
Overall Study COMPLETED	16	12
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Measure	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.	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.
Overall Study Withdrawal by Subject	1	3
Overall Study Protocol Violation	2	0

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Lidocaine Treatment Group n=16 Participants 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.	Placebo Treatment Group n=12 Participants 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.	Total n=28 Participants Total of all reporting groups
Age, Continuous	43.2 years STANDARD_DEVIATION 15.1 • n=5 Participants	44.1 years STANDARD_DEVIATION 14.7 • n=7 Participants	43.7 years STANDARD_DEVIATION 14.6 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	11 Participants n=7 Participants	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	15 Participants n=5 Participants	11 Participants n=7 Participants	26 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	16 participants n=5 Participants	12 participants n=7 Participants	28 participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

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.

Outcome measures

Measure	Lidocaine Treatment Group n=16 Participants 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.	Placebo Treatment Group n=12 Participants 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.
Pain Change	-3.8 units on a scale Interval -5.3 to -2.2	-4.0 units on a scale Interval -5.5 to -2.5

PRIMARY outcome

Timeframe: 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

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.

Outcome measures

Measure	Lidocaine Treatment Group n=16 Participants 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.	Placebo Treatment Group n=12 Participants 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.
Pain Change in 24 Hours (Self Reported Pain From Electronic Health Records)	-2.1 units on a scale Interval -4.6 to -0.5	-4.0 units on a scale Interval -5.1 to -2.9

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Measure	Lidocaine Treatment Group n=13 Participants 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.	Placebo Treatment Group n=12 Participants 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.
Change in Hydromorphone in 24 Hours	0.4 milligram morphine equivalents (MME) Interval -0.4 to 1.3	4.7 milligram morphine equivalents (MME) Interval -3.4 to 12.9

Adverse Events

Lidocaine Treatment Group

Serious events: 5 serious events

Other events: 5 other events

Deaths: 0 deaths

Placebo Treatment Group

Serious events: 2 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Measure	Lidocaine Treatment Group n=16 participants at risk 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.	Placebo Treatment Group n=12 participants at risk 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.
Infections and infestations Infection at donor site	31.2% 5/16 • Number of events 5 • 21 days 1. All-Cause Mortality: The occurrence of death due to any cause. 2. SAE: adverse events that result in: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. 3. Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events.	16.7% 2/12 • Number of events 2 • 21 days 1. All-Cause Mortality: The occurrence of death due to any cause. 2. SAE: adverse events that result in: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. 3. Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events.

Other adverse events

Measure	Lidocaine Treatment Group n=16 participants at risk 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.	Placebo Treatment Group n=12 participants at risk 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.
Blood and lymphatic system disorders Acute lood loss Anemia	12.5% 2/16 • Number of events 2 • 21 days 1. All-Cause Mortality: The occurrence of death due to any cause. 2. SAE: adverse events that result in: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. 3. Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events.	8.3% 1/12 • Number of events 1 • 21 days 1. All-Cause Mortality: The occurrence of death due to any cause. 2. SAE: adverse events that result in: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. 3. Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events.
Skin and subcutaneous tissue disorders Graft failure	6.2% 1/16 • Number of events 1 • 21 days 1. All-Cause Mortality: The occurrence of death due to any cause. 2. SAE: adverse events that result in: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. 3. Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events.	8.3% 1/12 • Number of events 1 • 21 days 1. All-Cause Mortality: The occurrence of death due to any cause. 2. SAE: adverse events that result in: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. 3. Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events.
Skin and subcutaneous tissue disorders Wound breakdown	6.2% 1/16 • Number of events 1 • 21 days 1. All-Cause Mortality: The occurrence of death due to any cause. 2. SAE: adverse events that result in: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. 3. Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events.	0.00% 0/12 • 21 days 1. All-Cause Mortality: The occurrence of death due to any cause. 2. SAE: adverse events that result in: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. 3. Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events.
Renal and urinary disorders Acute kidney injury	6.2% 1/16 • Number of events 1 • 21 days 1. All-Cause Mortality: The occurrence of death due to any cause. 2. SAE: adverse events that result in: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. 3. Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events.	0.00% 0/12 • 21 days 1. All-Cause Mortality: The occurrence of death due to any cause. 2. SAE: adverse events that result in: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. 3. Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events.
Investigations Prolongation of hospitalization	0.00% 0/16 • 21 days 1. All-Cause Mortality: The occurrence of death due to any cause. 2. SAE: adverse events that result in: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. 3. Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events.	8.3% 1/12 • Number of events 1 • 21 days 1. All-Cause Mortality: The occurrence of death due to any cause. 2. SAE: adverse events that result in: death, a life-threatening adverse event, inpatient hospitalization or prolongation of existing hospitalization, a persistent or significant incapacity or substantial disruption of the ability to conduct normal functions, or a congenital anomaly/birth defect. 3. Other (Not Including Serious) Adverse Events: Adverse events that are not Serious Adverse Events.

Additional Information

Brenda Fahy, MD

University of Florida

Phone: 859-402-4360

Email: bfahy@anest.ufl.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place