Continuous Lidocaine Infusion for Management of Perioperative Burn Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by HealthPartners Institute for Education and Research
Sponsor:
Information provided by (Responsible Party):
HealthPartners Institute for Education and Research
ClinicalTrials.gov Identifier:
NCT02059902
First received: February 10, 2014
Last updated: NA
Last verified: February 2014
History: No changes posted
  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. We 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
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 for Education and Research:

Primary Outcome Measures:
  • Narcotic consumption (measured in equivalent morphine dose) [ Time Frame: 24-hours post surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: September 2012
Estimated Study Completion Date: June 2015
Estimated 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)
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02059902

Contacts
Contact: Sandi Wewerka, MPH 651-254-5304 sandi.s.wewerka@healthpartners.com
Contact: Josh Salzman, MA 651-254-5302 joshua.g.salzman@healthpartners.com

Locations
United States, Minnesota
Regions Hospital Recruiting
St. Paul, Minnesota, United States, 55101
Contact: Sandi Wewerka, MPH    651-254-5304    sandi.s.wewerka@healthpartners.com   
Contact: Josh Salzman, MA    651-254-5302    joshua.g.salzman@healthpartners.com   
Principal Investigator: William Mohr, MD         
Sponsors and Collaborators
HealthPartners Institute for Education and Research
Investigators
Principal Investigator: William Mohr, MD Regions Hospital
Study Director: Sandi Wewerka, MPH Regions Hospital
  More Information

No publications provided

Responsible Party: HealthPartners Institute for Education and Research
ClinicalTrials.gov Identifier: NCT02059902     History of Changes
Other Study ID Numbers: 12-105
Study First Received: February 10, 2014
Last Updated: February 10, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by HealthPartners Institute for Education and Research:
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
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on July 20, 2014