Efficacy and Safety of Lidocaine Infusion Treatment in Management of Neuropathic Pain

Study Overview
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Brief Summary
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The investigators conducted a randomized, Double blind, and Controlled Study to evaluate the Efficacy and safety of Lidocaine Infusion Treatment in Management of Neuropathic pain.

Detailed Description
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The investigators expect pain improvement after treatment with 3 mg/kg of lidocaine, continuously infused in normal saline 250 ml.

Official Title
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Efficacy and Safety of Lidocaine Infusion Treatment in Management of Neuropathic Pain: Randomized, Controlled, Comparative Study

Conditions
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Postherpetic Neuralgia, Diabetic Polyneuropathy, Peripheral Neuropathy

Intervention / Treatment
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* Drug: Lidocaine HCl
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: postherpetic neuralgia, diabetic polyneuropathy, peripheral neuropathy NRS score > 4 stable oral medication during the 1 month trial period volunteers with informed consent Exclusion Criteria: pregnancy, breastfeeding, possibility of pregnancy pain from causes other than upper 3 indications hypersensitivity to lidocaine or other local anesthetics important disease of heart, kidney, liver or incurable disease that may affect the assessment of adverse effects, or may interfere with the completion of study severe conduction block history of other interventions that may affect the study Enrollment in other clinical trials within 30 days otherwise not suitable to study

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Normal Saline<br>normal saline total 250 ml once a week 4 times | Drug: Normal saline<br>* Normal saline continuous infusion<br>* Other names: 228714BIJ, ISOTONIC SODIUM CHLORIDE DAEHAN PHARM. CO., LTD.;|
| Active Comparator: Lidocaine HCl<br>lidocaine 3 mg/kg mixed in normal saline total 250 ml once a week 4 times | Drug: Lidocaine HCl<br>* lidocaine continuous infusion<br>* Other names: 183903BIJ, Lidocaine HCl inj. 2% DAEHAN PHARM. CO., LTD.;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 11-point Numeric Rating Scale | Rating averaged daily pain score over a 7-day period, 0=on pain to 10=worst possible pain | 1 week after the end of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brief Pain Inventory Short Form | measurements of pain intensity, functionality, and impact of pain, rated on an 11-point Numerical Rating Scale (NRS) [0=no pain to 10=worst possible pain] | at the end of intervention and 4 weeks after the end of intervention | 
| Shot Form McGill Pain Questionnaire | 15 pain descriptors ranked on a 4-stage intensity scale, the Present Pain Intensity index ranked on a 6-stage intensity and VAS (100-mm scale) | at the end of intervention and 4 weeks after the end of intervention | 
| Patient Global Impression of Change | 7-point scale from very much improved to very much worse | at the end of intervention and 4 weeks after the end of intervention | 
| Number of patients with grade 3 through grade 5 adverse events that are related to study drug, graded according to NCI CTCAE version 4.0 | AEs, laboratory values, vital signs, 12-lead ECG, finding from physical examination The intensity of AEs was graded according to the NCI common terminology criteria for adverse events v 4.0 on five point scale (grade 1 to 5: mild, moderate, severe, life-threatening and Death) | through the study completion (7 weeks) | 
| 11-point Numeric Rating Scale | Rating averaged daily pain score over a 7-day period, 0=on pain to 10=worst possible pain | 4 weeks after the end of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lidocaine infusion therapy