Trial Outcomes & Findings for Lidocaine for Diabetic Peripheral Neuropathy (NCT NCT02363803)
NCT ID: NCT02363803
Last Updated: 2019-11-15
Results Overview
Spontaneous pain will be assessed on numerical rating scale NRS (0= no pain, 10=worst pain imaginable) prior to infusion and then repeatedly for 120 minutes. The outcome measure will use the average of pain intensity measured at timepoints in the 60-120 min range after beginning of infusion. The mean %change in pain (from baseline) will be compared between lidocaine and placebo arms.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
34 participants
Primary outcome timeframe
Baseline compared to 60-120 minutes after starting the infusion
Results posted on
2019-11-15
Participant Flow
One participant only received lidocaine infusion and did not return to receive saline infusion.
Participant milestones
| Measure |
Saline First, Then Lidocaine
Intravenous infusion of normal saline (placebo) over a 40 minute period (Period 1). Intravenous infusion of lidocaine 5mg/kg IBW over a 40 min period (Period 2)
|
Lidocaine First, Then Saline
Intravenous infusion of lidocaine 5mg/kg IBW over a 40 min period (Period 1). Intravenous infusion of normal saline (placebo) over a 40 minute period (Period 2).
|
|---|---|---|
|
Period 1
STARTED
|
17
|
17
|
|
Period 1
COMPLETED
|
17
|
17
|
|
Period 1
NOT COMPLETED
|
0
|
0
|
|
Period 2
STARTED
|
17
|
16
|
|
Period 2
COMPLETED
|
17
|
16
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Lidocaine for Diabetic Peripheral Neuropathy
Baseline characteristics by cohort
| Measure |
Saline First, Then Lidocaine
n=17 Participants
Intravenous infusion of normal saline (placebo) over a 40 minute period (Period 1). Intravenous infusion of lidocaine 5mg/kg IBW over a 40 min period (Period 2)
|
Lidocaine First, Then Saline
n=17 Participants
Intravenous infusion of lidocaine 5mg/kg IBW over a 40 min period (Period 1). Intravenous infusion of normal saline (placebo) over a 40 minute period (Period 2).
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 12 • n=5 Participants
|
56 years
STANDARD_DEVIATION 10 • n=7 Participants
|
57 years
STANDARD_DEVIATION 11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (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
|
17 participants
n=5 Participants
|
17 participants
n=7 Participants
|
34 participants
n=5 Participants
|
|
Average pain intensity within the past week
|
6 units on a scale
n=5 Participants
|
6.5 units on a scale
n=7 Participants
|
6.25 units on a scale
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline compared to 60-120 minutes after starting the infusionPopulation: Participants who completed both infusions and had non-zero pain scores at the start of each infusion.
Spontaneous pain will be assessed on numerical rating scale NRS (0= no pain, 10=worst pain imaginable) prior to infusion and then repeatedly for 120 minutes. The outcome measure will use the average of pain intensity measured at timepoints in the 60-120 min range after beginning of infusion. The mean %change in pain (from baseline) will be compared between lidocaine and placebo arms.
Outcome measures
| Measure |
Normal Saline Infusion
n=31 Participants
Intravenous infusion of normal saline over a 40 minute period.
Placebo: Normal saline, approved for hypovolemia, and homeostasis.
|
Lidocaine Infusion
n=31 Participants
Intravenous infusion of lidocaine \[5mg/kg\] over a 40 minute period.
lidocaine: lidocaine is a sodium channel blocker/analgesic. It is approved for intravenous administration for cardiac arrhythmias.
|
Lidocaine: Prior to Infusion
Intravenous infusion of lidocaine \[5mg/kg\] over a 40 minute period.
|
Lidocaine: 60 Minutes After Infusion Initiation
Intravenous infusion of lidocaine \[5mg/kg\] over a 40 minute period.
|
|---|---|---|---|---|
|
Change in Spontaneous Pain at 60-120 Minutes After Lidocaine Infusion Initiated (Assessed on 0-10 NRS)
|
33 percentage of pain change from baseline
Standard Deviation 46
|
51 percentage of pain change from baseline
Standard Deviation 40
|
—
|
—
|
SECONDARY outcome
Timeframe: - 60 minutes (baseline) and + 60 minutes of initiating infusionPopulation: Participants who received both lidocaine and normal saline infusions were analyzed.
Thermal and mechanical responses will be assessed at baseline and 60 minutes after infusions. Evoked intensities measured on a 0-10 sensory scale, where 5 is normal sensation, a number lower than 5 is reduced sensation and a number higher than 5 is greater sensation.
Outcome measures
| Measure |
Normal Saline Infusion
n=33 Participants
Intravenous infusion of normal saline over a 40 minute period.
Placebo: Normal saline, approved for hypovolemia, and homeostasis.
|
Lidocaine Infusion
n=33 Participants
Intravenous infusion of lidocaine \[5mg/kg\] over a 40 minute period.
lidocaine: lidocaine is a sodium channel blocker/analgesic. It is approved for intravenous administration for cardiac arrhythmias.
|
Lidocaine: Prior to Infusion
n=33 Participants
Intravenous infusion of lidocaine \[5mg/kg\] over a 40 minute period.
|
Lidocaine: 60 Minutes After Infusion Initiation
n=33 Participants
Intravenous infusion of lidocaine \[5mg/kg\] over a 40 minute period.
|
|---|---|---|---|---|
|
Evoked Mechanical and Thermal Sensation at Baseline and 60 Minutes After Infusion Initiation.
Cold intensity
|
2 score on a scale
Interval 1.0 to 4.0
|
4 score on a scale
Interval 2.0 to 5.0
|
3 score on a scale
Interval 1.0 to 4.0
|
3 score on a scale
Interval 1.0 to 4.0
|
|
Evoked Mechanical and Thermal Sensation at Baseline and 60 Minutes After Infusion Initiation.
Heat intensity
|
2 score on a scale
Interval 0.0 to 3.0
|
2 score on a scale
Interval 0.0 to 3.5
|
2 score on a scale
Interval 0.0 to 3.0
|
1 score on a scale
Interval 0.0 to 3.0
|
|
Evoked Mechanical and Thermal Sensation at Baseline and 60 Minutes After Infusion Initiation.
Brush intensity
|
4 score on a scale
Interval 3.0 to 5.0
|
4 score on a scale
Interval 2.0 to 5.0
|
5 score on a scale
Interval 2.0 to 5.0
|
4 score on a scale
Interval 1.5 to 5.0
|
|
Evoked Mechanical and Thermal Sensation at Baseline and 60 Minutes After Infusion Initiation.
Pinprick intensity
|
4 score on a scale
Interval 1.5 to 6.0
|
3 score on a scale
Interval 1.0 to 5.5
|
4 score on a scale
Interval 1.5 to 6.0
|
3 score on a scale
Interval 1.0 to 5.5
|
SECONDARY outcome
Timeframe: Baseline to 60 minutes of initiating infusionPopulation: Participants who received both lidocaine and normal saline infusions analyzed.
NPSI pain descriptors will be assessed prior to infusion of placebo and lidocaine (baseline) and again at 60 minutes post-infusion. Descriptors are expressed on a 0-10 scale; 0-minimum (least), and 10 maximum (worst) score.
Outcome measures
| Measure |
Normal Saline Infusion
n=33 Participants
Intravenous infusion of normal saline over a 40 minute period.
Placebo: Normal saline, approved for hypovolemia, and homeostasis.
|
Lidocaine Infusion
n=33 Participants
Intravenous infusion of lidocaine \[5mg/kg\] over a 40 minute period.
lidocaine: lidocaine is a sodium channel blocker/analgesic. It is approved for intravenous administration for cardiac arrhythmias.
|
Lidocaine: Prior to Infusion
n=33 Participants
Intravenous infusion of lidocaine \[5mg/kg\] over a 40 minute period.
|
Lidocaine: 60 Minutes After Infusion Initiation
n=33 Participants
Intravenous infusion of lidocaine \[5mg/kg\] over a 40 minute period.
|
|---|---|---|---|---|
|
NPSI (Neuropathic Pain Symptom Inventory) Descriptors of Pain at Baseline and 60 Min After Infusion
Does your pain feel like burning?
|
3 score on a scale
Interval 0.0 to 4.0
|
0 score on a scale
Interval 0.0 to 2.0
|
3 score on a scale
Interval 0.0 to 5.0
|
0 score on a scale
Interval 0.0 to 1.0
|
|
NPSI (Neuropathic Pain Symptom Inventory) Descriptors of Pain at Baseline and 60 Min After Infusion
Does your pain feel like squeezing?
|
2 score on a scale
Interval 0.0 to 3.0
|
0 score on a scale
Interval 0.0 to 2.0
|
2 score on a scale
Interval 0.0 to 4.0
|
0 score on a scale
Interval 0.0 to 2.0
|
|
NPSI (Neuropathic Pain Symptom Inventory) Descriptors of Pain at Baseline and 60 Min After Infusion
Does your pain feel like electric shocks?
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 0.0
|
0 score on a scale
Interval 0.0 to 3.5
|
0 score on a scale
Interval 0.0 to 0.0
|
|
NPSI (Neuropathic Pain Symptom Inventory) Descriptors of Pain at Baseline and 60 Min After Infusion
Does your pain feel like stabbing?
|
0 score on a scale
Interval 0.0 to 2.0
|
0 score on a scale
Interval 0.0 to 0.5
|
0 score on a scale
Interval 0.0 to 4.5
|
0 score on a scale
Interval 0.0 to 0.0
|
|
NPSI (Neuropathic Pain Symptom Inventory) Descriptors of Pain at Baseline and 60 Min After Infusion
Do you feel pins and needles?
|
2 score on a scale
Interval 0.0 to 5.5
|
0 score on a scale
Interval 0.0 to 3.5
|
4 score on a scale
Interval 0.0 to 5.0
|
0 score on a scale
Interval 0.0 to 0.0
|
|
NPSI (Neuropathic Pain Symptom Inventory) Descriptors of Pain at Baseline and 60 Min After Infusion
Do you feel tingling?
|
3 score on a scale
Interval 0.0 to 5.0
|
1 score on a scale
Interval 0.0 to 3.0
|
4 score on a scale
Interval 1.5 to 6.0
|
1 score on a scale
Interval 0.0 to 3.0
|
SECONDARY outcome
Timeframe: baseline to 60-120 minutes after starting the infusionPopulation: Participants who completed both infusions and had non-zero pain scores at the start of each infusion.
Correlation between Mechanical Pain Threshold (MPT in mN) at baseline and reduction in spontaneous pain intensity (% reduction on 0-10 NRS) at 60-120 minutes (averaged) from the study drug infusion. The slopes (Pearson coefficients) of the correlation obtained from lidocaine vs. placebo will be compared.
Outcome measures
| Measure |
Normal Saline Infusion
n=31 Participants
Intravenous infusion of normal saline over a 40 minute period.
Placebo: Normal saline, approved for hypovolemia, and homeostasis.
|
Lidocaine Infusion
n=31 Participants
Intravenous infusion of lidocaine \[5mg/kg\] over a 40 minute period.
lidocaine: lidocaine is a sodium channel blocker/analgesic. It is approved for intravenous administration for cardiac arrhythmias.
|
Lidocaine: Prior to Infusion
Intravenous infusion of lidocaine \[5mg/kg\] over a 40 minute period.
|
Lidocaine: 60 Minutes After Infusion Initiation
Intravenous infusion of lidocaine \[5mg/kg\] over a 40 minute period.
|
|---|---|---|---|---|
|
Change in Spontaneous Pain Intensity as a Function of Baseline MPT
|
.249 Pearson coefficient
Interval -0.098 to 0.538
|
.063 Pearson coefficient
Interval -0.308 to 0.404
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline to 60-120 minutes after starting the infusionPopulation: Participants who completed both infusions and had non-zero pain scores at the start of each infusion. Two additional participants excluded as they could not sense heat on test site.
Correlation between Heat Pain Threshold (HPT in degrees Celsius) at baseline and reduction in spontaneous pain intensity (% reduction on 0-10 NRS) at 60-120 minutes (averaged) from the study drug infusion. The slopes (Pearson coefficients) of the correlation obtained from lidocaine vs. placebo will be compared.
Outcome measures
| Measure |
Normal Saline Infusion
n=29 Participants
Intravenous infusion of normal saline over a 40 minute period.
Placebo: Normal saline, approved for hypovolemia, and homeostasis.
|
Lidocaine Infusion
n=29 Participants
Intravenous infusion of lidocaine \[5mg/kg\] over a 40 minute period.
lidocaine: lidocaine is a sodium channel blocker/analgesic. It is approved for intravenous administration for cardiac arrhythmias.
|
Lidocaine: Prior to Infusion
Intravenous infusion of lidocaine \[5mg/kg\] over a 40 minute period.
|
Lidocaine: 60 Minutes After Infusion Initiation
Intravenous infusion of lidocaine \[5mg/kg\] over a 40 minute period.
|
|---|---|---|---|---|
|
Change in Spontaneous Pain Intensity as a Function of Baseline HPT
|
.023 Pearson coefficient
Interval -0.372 to 0.493
|
-.151 Pearson coefficient
Interval -0.467 to 0.206
|
—
|
—
|
Adverse Events
Normal Saline Infusion
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Lidocaine Infusion
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Normal Saline Infusion
n=33 participants at risk
Intravenous infusion of normal saline over a 40 minute period.
Placebo: Normal saline, approved for hypovolemia, and homeostasis.
|
Lidocaine Infusion
n=34 participants at risk
Intravenous infusion of lidocaine \[5mg/kg\] over a 40 minute period.
lidocaine: lidocaine is a sodium channel blocker/analgesic. It is approved for intravenous administration for cardiac arrhythmias.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Dry mouth
|
24.2%
8/33 • 0-120 minutes after infusion initiation
|
38.2%
13/34 • 0-120 minutes after infusion initiation
|
|
Nervous system disorders
Drowsiness
|
12.1%
4/33 • 0-120 minutes after infusion initiation
|
26.5%
9/34 • 0-120 minutes after infusion initiation
|
|
Nervous system disorders
Perioral numbness
|
6.1%
2/33 • 0-120 minutes after infusion initiation
|
23.5%
8/34 • 0-120 minutes after infusion initiation
|
|
Nervous system disorders
Dizziness
|
3.0%
1/33 • 0-120 minutes after infusion initiation
|
17.6%
6/34 • 0-120 minutes after infusion initiation
|
|
Nervous system disorders
Dysesthesia
|
3.0%
1/33 • 0-120 minutes after infusion initiation
|
20.6%
7/34 • 0-120 minutes after infusion initiation
|
|
Nervous system disorders
Nausea
|
0.00%
0/33 • 0-120 minutes after infusion initiation
|
5.9%
2/34 • 0-120 minutes after infusion initiation
|
|
Nervous system disorders
Blurred vision
|
0.00%
0/33 • 0-120 minutes after infusion initiation
|
2.9%
1/34 • 0-120 minutes after infusion initiation
|
|
Nervous system disorders
Headache
|
3.0%
1/33 • 0-120 minutes after infusion initiation
|
2.9%
1/34 • 0-120 minutes after infusion initiation
|
|
Cardiac disorders
Arrhythmia
|
3.0%
1/33 • 0-120 minutes after infusion initiation
|
0.00%
0/34 • 0-120 minutes after infusion initiation
|
|
Nervous system disorders
Slurred speech
|
0.00%
0/33 • 0-120 minutes after infusion initiation
|
5.9%
2/34 • 0-120 minutes after infusion initiation
|
Additional Information
Dr. Simon Haroutounian
Washington University in St. Louis
Phone: 3143622628
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place