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

Seoul National University Hospital44 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Postherpetic Neuralgia Diabetic Polyneuropathy Peripheral Neuropathy

Interventions

Lidocaine HClDRUG

lidocaine continuous infusion

Normal salineDRUG

Normal saline continuous infusion

Eligibility

Sex: ALLMin age: 20 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Yong Chul Kim

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

11-point Numeric Rating Scale

Rating averaged daily pain score over a 7-day period, 0=on pain to 10=worst possible pain

Time frame: 1 week after the end of intervention

Secondary Outcomes

Brief Pain Inventory Short Form

measurements of pain intensity, functionality, and impact of pain, rated on an 11-point Numerical Rating Scale (NRS) \[0=no pain to 10=worst possible pain\]

Time frame: 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)

Time frame: 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

Time frame: 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)

Time frame: 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

Time frame: 4 weeks after the end of intervention

Central Contacts

Yong Chul Kim

CONTACT

+82-2-2072-3289 pain@snu.ac.kr

Data from ClinicalTrials.gov

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