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Continuous Lidocaine Infusion for Management of Perioperative Burn Pain

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02059902
First Posted: February 11, 2014
Last Update Posted: June 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
HealthPartners Institute
  Purpose
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.

Condition Intervention Phase
Thermal Burns Drug: Lidocaine Other: Placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Continuous Lidocaine Infusion for Management of Perioperative Burn Pain

Resource links provided by NLM:


Further study details as provided by HealthPartners Institute:

Primary Outcome Measures:
  • 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.


Enrollment: 36
Study Start Date: September 2012
Study Completion Date: February 2015
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Normal pain management
Normal saline (bolus followed by continuous infusion)
Other: Placebo
Normal saline runs for a total of 24 hours
Experimental: 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)
Drug: Lidocaine
Lidocaine infusion runs for a total of 24 hours

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02059902


Locations
United States, Minnesota
Regions Hospital
Saint Paul, Minnesota, United States, 55101
Sponsors and Collaborators
HealthPartners Institute
Investigators
Principal Investigator: William Mohr, MD Regions Hospital
Study Director: Sandi Wewerka, MPH Regions Hospital
  More Information

Responsible Party: HealthPartners Institute
ClinicalTrials.gov Identifier: NCT02059902     History of Changes
Other Study ID Numbers: 12-105
First Submitted: February 10, 2014
First Posted: February 11, 2014
Results First Submitted: February 20, 2017
Results First Posted: June 7, 2017
Last Update Posted: June 7, 2017
Last Verified: March 2015

Keywords provided by HealthPartners Institute:
Pain management
Narcotic consumption
Skin graft

Additional relevant MeSH terms:
Burns
Wounds and Injuries
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action