MedDataX Logo

Trial Outcomes & Findings for Continuous Lidocaine Infusion for Management of Perioperative Burn Pain (NCT NCT02059902)

NCT ID: NCT02059902

Last Updated: 2018-07-03

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

36 participants

Primary outcome timeframe

24-hours post surgery

Results posted on

2018-07-03

Participant Flow

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).

Participant milestones

Participant milestones
Measure
Normal Pain Management
Normal saline (bolus followed by continuous infusion) Placebo: Normal saline runs for a total of 24 hours
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) Lidocaine: Lidocaine infusion runs for a total of 24 hours
Overall Study
STARTED
18
18
Overall Study
COMPLETED
14
14
Overall Study
NOT COMPLETED
4
4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Continuous Lidocaine Infusion for Management of Perioperative Burn Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Normal Pain Management
n=14 Participants
Normal saline (bolus followed by continuous infusion) Placebo: Normal saline runs for a total of 24 hours
Lidocaine
n=14 Participants
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
n=28 Participants
Total of all reporting groups
Age, Continuous
43.5 years
n=5 Participants
35.7 years
n=7 Participants
39.48 years
n=5 Participants
Sex: Female, Male
Female
3 Participants
n=5 Participants
2 Participants
n=7 Participants
5 Participants
n=5 Participants
Sex: Female, Male
Male
11 Participants
n=5 Participants
12 Participants
n=7 Participants
23 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=5 Participants
1 Participants
n=7 Participants
1 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
14 Participants
n=5 Participants
13 Participants
n=7 Participants
27 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Region of Enrollment
United States
14 participants
n=5 Participants
14 participants
n=7 Participants
28 participants
n=5 Participants
Total Burn Surface Area
17.77 total percentage of body area burned
n=5 Participants
11.18 total percentage of body area burned
n=7 Participants
14.48 total percentage of body area burned
n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure
Normal Pain Management
n=14 Participants
Normal saline (bolus followed by continuous infusion) Placebo: Normal saline runs for a total of 24 hours
Lidocaine
n=14 Participants
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
Narcotic Consumption (Measured in mg/kg Narcotic Consumption)
57.5 mg/kg narcotic consumption
Interval 35.0 to 105.0
67.75 mg/kg narcotic consumption
Interval 50.0 to 134.0

Adverse Events

Normal Pain Management

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Lidocaine

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. William J Mohr

Health Partners

Phone: (651)454-5304

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place