Continuous Lidocaine Infusion for Management of Perioperative Burn Pain

NCT02059902 | Completed Phase 4 Results

• 1 other identifier: 12-105
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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

Keywords

Pain management; Narcotic consumption; Skin graft

Outcome Measures

Primary Outcomes (1)

• Narcotic Consumption (Measured in mg/kg Narcotic Consumption)

  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.

  24-hours post surgery

Study Arms (2)

Normal pain management

PLACEBO COMPARATOR

Normal saline (bolus followed by continuous infusion)

Other: Placebo

Lidocaine

EXPERIMENTAL

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

Interventions

Lidocaine DRUG

Lidocaine infusion runs for a total of 24 hours

Lidocaine

Placebo OTHER

Normal saline runs for a total of 24 hours

Normal pain management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Burn patient ≥ 18 years of age
• Burn patient scheduled to go to OR for excision and/or grafting procedure

You may not qualify if:

• 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

Sponsors & Collaborators

• HealthPartners Institute: lead

Study Sites (1)

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

MeSH Terms

Conditions

Agnosia

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. William J Mohr
• Organization: Health Partners

William.J.Mohr@healthpartners.com

(651)454-5304

Study Officials

• William Mohr, MD

  Regions Hospital

  PRINCIPAL INVESTIGATOR

• Sandi Wewerka, MPH

  Regions Hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2014
• First Posted: February 11, 2014
• Study Start: September 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: February 1, 2015
• Last Updated: July 3, 2018
• Results First Posted: June 7, 2017

Record last verified: 2018-06

Locations

US (1)