Lidocaine for Diabetic Peripheral Neuropathy

NCT02363803 | Completed Results

• 1 other identifier: 201412073
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

Diabetic nerve pain \[painful diabetic peripheral neuropathy\] is a common medical problem with few reliably effective treatments. There is some evidence that sensory testing may help determine how individuals will respond to analgesic therapy. In this study, the investigators are evaluating the relationship between sensory testing and subject response to lidocaine infusion therapy.

Conditions

Diabetes; Peripheral Neuropathy; Pain

Outcome Measures

Primary Outcomes (1)

• Change in Spontaneous Pain at 60-120 Minutes After Lidocaine Infusion Initiated (Assessed on 0-10 NRS)

  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.

  Baseline compared to 60-120 minutes after starting the infusion

Secondary Outcomes (4)

• Evoked Mechanical and Thermal Sensation at Baseline and 60 Minutes After Infusion Initiation.

  - 60 minutes (baseline) and + 60 minutes of initiating infusion

• NPSI (Neuropathic Pain Symptom Inventory) Descriptors of Pain at Baseline and 60 Min After Infusion

  Baseline to 60 minutes of initiating infusion

• Change in Spontaneous Pain Intensity as a Function of Baseline MPT

  baseline to 60-120 minutes after starting the infusion

• Change in Spontaneous Pain Intensity as a Function of Baseline HPT

  Baseline to 60-120 minutes after starting the infusion

Study Arms (2)

Normal saline infusion then lidocaine infusion

PLACEBO COMPARATOR

Intravenous infusion of normal saline over a 40 minute period. second intervention: Intravenous infusion of lidocaine \[5mg/kg\] over a 40 minute period.

Drug: lidocaine; Drug: Placebo

Lidocaine infusion, then normal saline infusion

ACTIVE COMPARATOR

Intravenous infusion of lidocaine \[5mg/kg\] over a 40 minute period. second intervention: Intravenous infusion of normal saline over a 40 minute period.

Drug: lidocaine; Drug: Placebo

Interventions

lidocaine DRUG

lidocaine is a sodium channel blocker/analgesic. It is approved for intravenous administration for cardiac arrhythmias.

Lidocaine infusion, then normal saline infusion; Normal saline infusion then lidocaine infusion

Placebo DRUG

Normal saline, approved for hypovolemia, and homeostasis.

Lidocaine infusion, then normal saline infusion; Normal saline infusion then lidocaine infusion

Eligibility Criteria

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

You may qualify if:

• Age ≥18;
• Diagnosis of Diabetes Mellitus (Fasting Plasma Glucose \> 126 mg/dL and/or HbA1C \>6.5%);
• Distal symmetric pain in lower extremities with duration of more than 3 months;
• Presence of either numbness or at least 1 sensory disturbance (increased or decreased sensitivity) in the feet.
• Spontaneous pain with intensity of ≥ 4 on 0-10 Numerical Rating Scale (NRS).

You may not qualify if:

• Not giving consent to participate in the study;
• Unable to complete self-report pain questionnaire;
• History of moderate to severe renal or liver failure;
• History of other central or peripheral neurologic disorders;
• History of cardiac arrhythmias;
• Contraindication to intravenous lidocaine;
• Pregnancy or lactation.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine/Barnes Jewish Hospital

St Louis, Missouri, 63110, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus; Peripheral Nervous System Diseases; Pain

Interventions

Lidocaine

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; 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. Simon Haroutounian
• Organization: Washington University in St. Louis

sharout@wustl.edu

3143622628

Study Officials

• Simon Haroutounian, PhD

  Department of Anesthesiology, WUSTL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 3, 2015
• First Posted: February 16, 2015
• Study Start: February 1, 2015
• Primary Completion: October 17, 2018
• Study Completion: October 17, 2018
• Last Updated: November 15, 2019
• Results First Posted: October 30, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)