Continuous Lidocaine Infusion for Management of Perioperative Burn Pain

NCT ID: NCT02059902

Last Updated: 2018-07-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-09-30
• Study Completion Date: 2015-02-28

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.

Conditions

Thermal Burns

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Normal pain management

Normal saline (bolus followed by continuous infusion)

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

Normal saline runs for a total of 24 hours

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)

Group Type: EXPERIMENTAL

Lidocaine

Intervention Type: DRUG

Lidocaine infusion runs for a total of 24 hours

Interventions

Lidocaine

Lidocaine infusion runs for a total of 24 hours

Intervention Type: DRUG

Placebo

Normal saline runs for a total of 24 hours

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HealthPartners Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

William Mohr, MD

Role: PRINCIPAL_INVESTIGATOR

Regions Hospital

Sandi Wewerka, MPH

Role: STUDY_DIRECTOR

Regions Hospital

Locations

Regions Hospital

Saint Paul, Minnesota, United States

Countries

United States

Other Identifiers

12-105

Identifier Type: -

Identifier Source: org_study_id