Continuous Lidocaine Infusion for Management of Perioperative Burn Pain
Primary Purpose
Thermal Burns
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Lidocaine
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Thermal Burns focused on measuring Pain management, Narcotic consumption, Skin graft
Eligibility Criteria
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
Sites / Locations
- Regions Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Normal pain management
Lidocaine
Arm Description
Normal saline (bolus followed by continuous infusion)
Lidocaine (Pre-operative = 1.5kg/mg over a minimum of 30 minutes; peri-operative = 2.0mg/kg/hour; Post-operative = 1.5kg/mg/hour)
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02059902
First Posted
February 10, 2014
Last Updated
June 5, 2018
Sponsor
HealthPartners Institute
1. Study Identification
Unique Protocol Identification Number
NCT02059902
Brief Title
Continuous Lidocaine Infusion for Management of Perioperative Burn Pain
Official Title
Continuous Lidocaine Infusion for Management of Perioperative Burn Pain
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
February 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
HealthPartners Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thermal Burns
Keywords
Pain management, Narcotic consumption, Skin graft
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Normal pain management
Arm Type
Placebo Comparator
Arm Description
Normal saline (bolus followed by continuous infusion)
Arm Title
Lidocaine
Arm Type
Experimental
Arm Description
Lidocaine (Pre-operative = 1.5kg/mg over a minimum of 30 minutes; peri-operative = 2.0mg/kg/hour; Post-operative = 1.5kg/mg/hour)
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Description
Lidocaine infusion runs for a total of 24 hours
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Normal saline runs for a total of 24 hours
Primary Outcome Measure Information:
Title
Narcotic Consumption (Measured in mg/kg Narcotic Consumption)
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
William Mohr, MD
Organizational Affiliation
Regions Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Sandi Wewerka, MPH
Organizational Affiliation
Regions Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Regions Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Continuous Lidocaine Infusion for Management of Perioperative Burn Pain
We'll reach out to this number within 24 hrs