N/A Completed N=34 Randomized Double-blind Treatment

Lidocaine for Diabetic Peripheral Neuropathy

Diabetes · peripheral neuropathy · Postoperative Pain

Source: ClinicalTrials.gov NCT02363803 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2019

Primary outcomePrimary: Change in Spontaneous Pain at 60-120 Minutes After Lidocaine Infusion Initiated (Assessed on 0-10 NRS) — 33; 51 percentage of pain change from baseline — p=0.03

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Spontaneous Pain at 60-120 Minutes After Lidocaine Infusion Initiated (Assessed on 0-10 NRS)	33; 51	0.03 sig
SECONDARY Evoked Mechanical and Thermal Sensation at Baseline and 60 Minutes After Infusion Initiation.	2; 4; 3; 3; 2; 2	—
SECONDARY NPSI (Neuropathic Pain Symptom Inventory) Descriptors of Pain at Baseline and 60 Min After Infusion	3; 0; 3; 0; 2; 0	—
SECONDARY Change in Spontaneous Pain Intensity as a Function of Baseline MPT	.249; .063	—
SECONDARY Change in Spontaneous Pain Intensity as a Function of Baseline HPT	.023; -.151	—

Eligibility Criteria

Inclusion Criteria

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).

Exclusion Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02363803). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.