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OpenTrials
Completed

NCT Number: NCT02059902

Continuous Lidocaine Infusion for Management of Perioperative Burn Pain

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine

Drug

Lidocaine infusion runs for a total of 24 hours

Placebo

Other

Normal saline runs for a total of 24 hours

Primary outcomes

  1. Narcotic Consumption (Measured in mg/kg Narcotic Consumption)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

HealthPartners Institute

Other

Registry information

Important dates

Study start
2012
Primary completion
2014
Study completion
2015
First posted
Feb 11, 2014
Registry last updated
Jul 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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