Continuous Lidocaine Infusion for Management of Perioperative Burn Pain

• Sponsor: HealthPartners Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT02059902
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Arms: 2
• Duration (Months): 29
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Thermal Burns	Drug: Lidocaine; Other: Placebo	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• 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
• Study Start Date: Sep 1, 2012
• Actual Primary Completion Date: Sep 1, 2014
• Actual Study Completion Date: Feb 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: HealthPartners Institute
• ClinicalTrials.gov Identifier: NCT02059902
• Other Study ID Numbers: 12-105
• First Posted: Feb 11, 2014
• Last Update Posted: Jul 3, 2018
• Last Verified: Jun 1, 2018

• Keywords provided by HealthPartners Institute: Pain management; Narcotic consumption; Skin graft
• Additional relevant MeSH terms: Burns; Lidocaine

Study Results

Participant Flow

Pre-assignment Detail	36 patients were consented during the study period, 28 patients randomized and treated: 14 placebo vs. 14 lidocaine. Patients were excluded after signing consent for: arriving to the pre-op area wearing a Lidocaine patch, changes in surgery times, lack of grafting/surgery needs, and medical contraindications (such as lidocaine with metoprolol).

Arm/Group Title	Normal Pain Management	Lidocaine
Arm/Group Description	Normal saline (bolus followed by continuous infusion) Placebo: Normal saline runs for a total of 24 hours	Lidocaine (Pre-operative = 1.5kg/mg over a minimum of 30 minutes; peri-operative = 2.0mg/kg/hour; Post-operative = 1.5kg/mg/hour) Lidocaine: Lidocaine infusion runs for a total of 24 hours
Period Title: Overall Study
STARTED	18	18
COMPLETED	14	14
NOT COMPLETED	4	4

Baseline Characteristics

Arm/Group Title	Normal Pain Management	Lidocaine	Total
Arm/Group Description	Normal saline (bolus followed by continuous infusion) Placebo: Normal saline runs for a total of 24 hours	Lidocaine (Pre-operative = 1.5kg/mg over a minimum of 30 minutes; peri-operative = 2.0mg/kg/hour; Post-operative = 1.5kg/mg/hour) Lidocaine: Lidocaine infusion runs for a total of 24 hours	Total of all reporting groups
Overall Participants	14	14	28
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	43.5	35.7	39.48
Sex: Female, Male (Count of Participants)
Female	3 21.4%	2 14.3%	5 17.9%
Male	11 78.6%	12 85.7%	23 82.1%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	1 7.1%	1 3.6%
Not Hispanic or Latino	14 100%	13 92.9%	27 96.4%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	14 100%	14 100%	28 100%
Total Burn Surface Area (total percentage of body area burned) [Mean (Full Range) ]
Mean (Full Range) [total percentage of body area burned]	17.77	11.18	14.48

Outcome Measures

1. Primary Outcome

Title	Narcotic Consumption (Measured in mg/kg Narcotic Consumption)
Description	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.
Time Frame	24-hours post surgery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Normal Pain Management	Lidocaine
Arm/Group Description	Normal saline (bolus followed by continuous infusion) Placebo: Normal saline runs for a total of 24 hours	Lidocaine (Pre-operative = 1.5kg/mg over a minimum of 30 minutes; peri-operative = 2.0mg/kg/hour; Post-operative = 1.5kg/mg/hour) Lidocaine: Lidocaine infusion runs for a total of 24 hours
Measure Participants	14	14
Median (Inter-Quartile Range) [mg/kg narcotic consumption]	57.5	67.75

Adverse Events

Arm/Group Title	Normal Pain Management		Lidocaine
Arm/Group Description	Normal saline (bolus followed by continuous infusion) Placebo: Normal saline runs for a total of 24 hours		Lidocaine (Pre-operative = 1.5kg/mg over a minimum of 30 minutes; peri-operative = 2.0mg/kg/hour; Post-operative = 1.5kg/mg/hour) Lidocaine: Lidocaine infusion runs for a total of 24 hours
All Cause Mortality
	Normal Pain Management		Lidocaine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/14 (0%)
Serious Adverse Events
	Normal Pain Management		Lidocaine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/14 (0%)
Other (Not Including Serious) Adverse Events
	Normal Pain Management		Lidocaine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/14 (0%)		0/14 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.