Thermal Burns
Conditions
Keywords
Pain management, Narcotic consumption, Skin graft
Brief summary
Thermal injury results in one of the most intense and prolonged forms of pain the body can experience. Opioid narcotics are the most powerful drugs for acute and chronic pain, and their use in the perioperative period has been the mainstay of treatment; although medication requirements in burn patients are often underestimated. More medication may not be the answer, as relatively large doses of short acting opioids in the operative theater are associated with greater postoperative opioid consumption and higher pain scores. Furthermore, extensive use of opioids has resulted in the development of by hyperalgesia and allodynia. Lidocaine is an amide local anesthetic that has analgesic, anti-hyperalgesic, antiarrhythmic, and anti-inflammatory properties. Over the past 25 years, systemic lidocaine has been used for perioperative pain management in a variety of surgical procedures. The design of this study will examine if lidocaine will reduce the pain scores and narcotic utilization in patients undergoing surgical procedures for burn injuries. The intervention group will receive a bolus dose of lidocaine followed by a continuous infusion over 24 hours. The control group will get an equal volume of saline. The investigators will compare pain scores, opioid use, and narcotic equivalents based on body weight and burn surface area (BSA) grafted.
Interventions
DRUGLidocaine
Lidocaine infusion runs for a total of 24 hours
OTHERPlacebo
Normal saline runs for a total of 24 hours
Sponsors
HealthPartners Institute
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
No
Inclusion criteria
* Burn patient ≥ 18 years of age * Burn patient scheduled to go to OR for excision and/or grafting procedure
Exclusion criteria
* Burn patient \< 18 years of age * Intubated patient on sedation drip * Prolonged hypotension defined as Systolic Blood Pressure (SBP) \< 90 mm/Hg for greater than 30 minutes in the pre-op area * Severe underlying cardiovascular disease (documented ejection fraction \< 40%) * Documented conduction block, bradycardia or active congestive heart failure * Documented active gastritis or ulcers * Previous steroid medication history if documented adrenal insufficiency * Patient with documented liver disease * Patient with epilepsy or known seizure disorder * Pregnant Women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Narcotic Consumption (Measured in mg/kg Narcotic Consumption) | 24-hours post surgery | The infusion was initiated at 1.5mg/kg for 30 minutes prior to surgery start, followed by a 2.0 mg/kg/hr infusion at the time of incision start. The rate was reduced to 1.5mg/kg/hr for the remainder of the 24 hour period. A standardized post-operative pain management strategy (morphine and oxycodone) was followed by clinical staff, based on a standardized pain scale rating tool. The difference in narcotic consumption and number of pain medication doses over the 72-hour post-operative period was compared using an unadjusted Wilcoxon rank sum test due to non-normal data distribution. |
Countries
United States
Participant flow
Pre-assignment details
36 patients were consented during the study period, 28 patients randomized and treated: 14 placebo vs. 14 lidocaine. Patients were excluded after signing consent for: arriving to the pre-op area wearing a Lidocaine patch, changes in surgery times, lack of grafting/surgery needs, and medical contraindications (such as lidocaine with metoprolol).
Participants by arm
| Arm | Count |
|---|---|
| Normal Pain Management Normal saline (bolus followed by continuous infusion)
Placebo: Normal saline runs for a total of 24 hours | 14 |
| Lidocaine Lidocaine (Pre-operative = 1.5kg/mg over a minimum of 30 minutes; peri-operative = 2.0mg/kg/hour; Post-operative = 1.5kg/mg/hour)
Lidocaine: Lidocaine infusion runs for a total of 24 hours | 14 |
| Total | 28 |
Baseline characteristics
| Characteristic | Lidocaine | Total | Normal Pain Management |
|---|---|---|---|
| Age, Continuous | 35.7 years | 39.48 years | 43.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 27 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 14 participants | 28 participants | 14 participants |
| Sex: Female, Male Female | 2 Participants | 5 Participants | 3 Participants |
| Sex: Female, Male Male | 12 Participants | 23 Participants | 11 Participants |
| Total Burn Surface Area | 11.18 total percentage of body area burned | 14.48 total percentage of body area burned | 17.77 total percentage of body area burned |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 14 |
| other Total, other adverse events | 0 / 14 | 0 / 14 |
| serious Total, serious adverse events | 0 / 14 | 0 / 14 |
Outcome results
Primary
Narcotic Consumption (Measured in mg/kg Narcotic Consumption)
The infusion was initiated at 1.5mg/kg for 30 minutes prior to surgery start, followed by a 2.0 mg/kg/hr infusion at the time of incision start. The rate was reduced to 1.5mg/kg/hr for the remainder of the 24 hour period. A standardized post-operative pain management strategy (morphine and oxycodone) was followed by clinical staff, based on a standardized pain scale rating tool. The difference in narcotic consumption and number of pain medication doses over the 72-hour post-operative period was compared using an unadjusted Wilcoxon rank sum test due to non-normal data distribution.
Time frame: 24-hours post surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Normal Pain Management | Narcotic Consumption (Measured in mg/kg Narcotic Consumption) | 57.5 mg/kg narcotic consumption |
| Lidocaine | Narcotic Consumption (Measured in mg/kg Narcotic Consumption) | 67.75 mg/kg narcotic consumption |