Continuous Lidocaine Infusion for Management of Perioperative Burn Pain

HealthPartners Institute

Status and phase: Completed; Phase 4

Conditions: Thermal Burns

Treatments: Other: Placebo; Drug: Lidocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02059902

12-105

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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36 participants in 2 patient groups, including a placebo group

Normal pain management

Placebo Comparator group

Description:

Normal saline (bolus followed by continuous infusion)

Treatment:

Other: Placebo

Lidocaine

Experimental group

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)

Treatment:

Drug: Lidocaine