Lidocaine for Diabetic Peripheral Neuropathy
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|ClinicalTrials.gov Identifier: NCT02363803|
Recruitment Status : Completed
First Posted : February 16, 2015
Last Update Posted : July 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Peripheral Neuropathy Pain||Drug: lidocaine Drug: Placebo||Not Applicable|
Diabetic peripheral neuropathy [DPN] is caused by diabetes-related metabolic damage to the sensory nervous system. It affects more than 3 million Americans and is leading cause of nerve damage-associated pain worldwide. Currently approved drugs such as gabapentin, pregabalin, and duloxetine provide pain relief only in 1 out of 4 or 5 people with DPN, pointing to a great need to identify effective therapy for these patients. Recent literature suggests that certain methods of assessing sensory nerve function in neuropathic pain patients may provide prediction to individual analgesic response; however, no placebo-controlled studies have been performed with the primary goal of identifying treatment response predictors in DPN.
We propose in this study to examine whether sensory testing to determine mechanical pain threshold [MPT] or heat pain threshold [HPT] will predict the subject's response to IV lidocaine analgesic therapy. We hypothesize that people with painful DPN who have high MPT or HPT are more likely to respond to lidocaine treatment. This is a prospective, double blind, placebo-controlled study with the primary objective of determining whether the results from the sensory testing predict the response to systemic lidocaine in patients with painful DPN.
Consented subjects will attend a screening visit and two intervention visits, during which they will undergo sensory testing and receive intravenous lidocaine or placebo infusion in a cross-over design. At enrollment, each patient will be assigned a study number, which will match a previously prepared computer-generated list of randomization numbers to determine the sequence of interventions: lidocaine and then placebo, or vice versa. An unblinded research nurse coordinator will be assigned to match the study number with randomized treatment sequence, and this person will prepare the study medications, which will look identical. This research nurse coordinator will not be involved at any stage at patient assessment or data analysis. The participants and all other study personnel will be blinded to the treatment allocation.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||34 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Predicting Individual Response to Analgesic Treatment in Painful Diabetic Neuropathy|
|Actual Study Start Date :||February 2015|
|Actual Primary Completion Date :||October 17, 2018|
|Actual Study Completion Date :||October 17, 2018|
Placebo Comparator: Normal saline infusion
Intravenous infusion of normal saline over a 40 minute period.
Normal saline, approved for hypovolemia, and homeostasis.
Active Comparator: Lidocaine infusion
Intravenous infusion of lidocaine [5mg/kg] over a 40 minute period.
lidocaine is a sodium channel blocker/analgesic. It is approved for intravenous administration for cardiac arrhythmias.
- Change in spontaneous pain at 60-120 minutes after lidocaine infusion initiated (assessed on 0-10 NRS) [ Time Frame: Baseline compared to 60-120 minutes after starting the 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.
- Change in evoked mechanical and thermal sensation. [ Time Frame: - 60 minutes and + 60 minutes of initiating infusion ]Thermal and mechanical responses will be assessed before and after infusions. After infusion, this assessment will be performed every 10 minutes for 60 minutes.
- Change in NPSI (Neuropathic Pain Symptom Inventory) descriptors of pain from baseline to 60 min [ Time Frame: Baselline to 60 minutes of initiating infusion ]NPSI pain descriptors will be assessed prior to infusion of placebo and lidocaine and again at 60 minutes post-infusion. Change from baseline in total NPSI (Neuropathic Pain Symptom Inventory) score. The total NPSI score is comprised by adding 5 sub-scores (Burning pain, Pressing pain, Paroxysmal pain, Evoked pain, and Paresthesia/Dysesthesia) and is expressed on a 0-10 scale; 0-minimum (least), and 10 maximum (worst) score.
- Change in Spontaneous Pain Intensity as a Function of Baseline MPT [ Time Frame: baseline to 60-120 minutes after starting the 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.
- Change in Spontaneous Pain Intensity as a Function of Baseline HPT [ Time Frame: Baseline to 60-120 minutes after starting the infusion ]Correlation between Heat Pain Threshold (HPT in degrees Celcius) 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02363803
|United States, Missouri|
|Washington University School of Medicine/Barnes Jewish Hospital|
|Saint Louis, Missouri, United States, 63110|
|Principal Investigator:||Simon Haroutounian, PhD||Department of Anesthesiology, WUSTL|