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

Seoul National University Hospital1 site in 1 country44 target enrollmentAugust 2015

ConditionsPostherpetic Neuralgia Diabetic Polyneuropathy Peripheral Neuropathy

InterventionsNormal saline Lidocaine HCl

DrugsLidocaine HCl Normal saline

Overview

Phase: Phase 2
Intervention: Normal saline
Conditions: Postherpetic Neuralgia
Sponsor: Seoul National University Hospital
Enrollment: 44
Locations: 1
Primary Endpoint: 11-point Numeric Rating Scale
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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

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

Registry

clinicaltrials.gov

Start Date

August 2015

End Date

July 2016

Last Updated

10 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Seoul National University Hospital

Responsible Party

Principal Investigator

Yong Chul Kim

Professor

Seoul National University Hospital

Eligibility Criteria

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

Arms & Interventions

Normal Saline

* normal saline * total 250 ml * once a week * 4 times

Intervention: Normal saline

Lidocaine HCl

* lidocaine 3 mg/kg mixed in normal saline * total 250 ml * once a week * 4 times

Intervention: Lidocaine HCl

Outcomes

Primary Outcomes

11-point Numeric Rating Scale

Time Frame: 1 week after the end of intervention

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

Secondary Outcomes

Brief Pain Inventory Short Form(at the end of intervention and 4 weeks after the end of intervention)
Shot Form McGill Pain Questionnaire(at the end of intervention and 4 weeks after the end of intervention)
Patient Global Impression of Change(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(through the study completion (7 weeks))
11-point Numeric Rating Scale(4 weeks after the end of intervention)