Continuous Lidocaine Infusion for Management of Perioperative Burn Pain

Thermal Burns Clinical Trial

Official title:

Continuous Lidocaine Infusion for Management of Perioperative Burn Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02059902
• Other study ID #: 12-105
• Status: Completed
• Phase: Phase 4
• Start date: September 2012
• Est. completion date: February 2015

Study information

• Verified date: June 2018
• Source: HealthPartners Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 2015
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Burns
• Thermal Burns

Intervention

Drug:
• Lidocaine
Lidocaine infusion runs for a total of 24 hours

Other:
• Placebo
Normal saline runs for a total of 24 hours

Locations

Country	Name	City	State
United States	Regions Hospital	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
HealthPartners Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	24-hours post surgery