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

NCT ID: NCT02597257

Last Updated: 2015-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-07-31

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.

Conditions

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Postherpetic Neuralgia Diabetic Polyneuropathy Peripheral Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Normal Saline

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

Group Type PLACEBO_COMPARATOR

Normal saline

Intervention Type DRUG

Normal saline continuous infusion

Lidocaine HCl

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

Group Type ACTIVE_COMPARATOR

Lidocaine HCl

Intervention Type DRUG

lidocaine continuous infusion

Interventions

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Lidocaine HCl

lidocaine continuous infusion

Intervention Type DRUG

Normal saline

Normal saline continuous infusion

Intervention Type DRUG

Other Intervention Names

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183903BIJ, Lidocaine HCl inj. 2% DAEHAN PHARM. CO., LTD. 228714BIJ, ISOTONIC SODIUM CHLORIDE DAEHAN PHARM. CO., LTD.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ministry of Food and Drug Safety, Korea

OTHER_GOV

Sponsor Role collaborator

Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yong Chul Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yong Chul Kim, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Yong Chul Kim

Seoul, , South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Yong Chul Kim

Role: CONTACT

+82-2-2072-3289

Facility Contacts

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Yong Chul Kim, PhD

Role: primary

+82-2-2072-3289

References

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Kim YC, Castaneda AM, Lee CS, Jin HS, Park KS, Moon JY. Efficacy and Safety of Lidocaine Infusion Treatment for Neuropathic Pain: A Randomized, Double-Blind, and Placebo-Controlled Study. Reg Anesth Pain Med. 2018 May;43(4):415-424. doi: 10.1097/AAP.0000000000000741.

Reference Type DERIVED
PMID: 29381569 (View on PubMed)

Other Identifiers

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1720150047

Identifier Type: -

Identifier Source: org_study_id

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