Lidocaine for Diabetic Peripheral Neuropathy

NCT ID: NCT02363803

Last Updated: 2019-11-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-02-28
• Study Completion Date: 2018-10-17

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.

Detailed Description

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.

Conditions

Diabetes; Peripheral Neuropathy; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Normal saline infusion then lidocaine infusion

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

Group Type: PLACEBO_COMPARATOR

lidocaine

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

Normal saline, approved for hypovolemia, and homeostasis.

Lidocaine infusion, then normal saline infusion

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

Group Type: ACTIVE_COMPARATOR

lidocaine

Intervention Type: DRUG

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

Placebo

Intervention Type: DRUG

Normal saline, approved for hypovolemia, and homeostasis.

Interventions

lidocaine

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

Intervention Type: DRUG

Placebo

Normal saline, approved for hypovolemia, and homeostasis.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age ≥18;

2. Diagnosis of Diabetes Mellitus (Fasting Plasma Glucose > 126 mg/dL and/or HbA1C >6.5%);

3. Distal symmetric pain in lower extremities with duration of more than 3 months;

4. Presence of either numbness or at least 1 sensory disturbance (increased or decreased sensitivity) in the feet.

5. Spontaneous pain with intensity of ≥ 4 on 0-10 Numerical Rating Scale (NRS).

Exclusion Criteria

1. Not giving consent to participate in the study;

2. Unable to complete self-report pain questionnaire;

3. History of moderate to severe renal or liver failure;

4. History of other central or peripheral neurologic disorders;

5. History of cardiac arrhythmias;

6. Contraindication to intravenous lidocaine;

7. Pregnancy or lactation.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Washington University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

simon.haroutounian

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Simon Haroutounian, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Anesthesiology, WUSTL

Locations

Washington University School of Medicine/Barnes Jewish Hospital

St Louis, Missouri, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

201412073

Identifier Type: -

Identifier Source: org_study_id