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

Seoul National University

Status and phase: Unknown; Phase 2

Conditions: Postherpetic Neuralgia; Peripheral Neuropathy; Diabetic Polyneuropathy

Treatments: Drug: Normal saline; Drug: Lidocaine HCl

Study type: Interventional

Funder types: Other

Identifiers

NCT02597257

1720150047

Details and patient eligibility

About

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.

Full description

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

Enrollment: 44 estimated patients

Sex: All

Ages: 20 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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44 participants in 2 patient groups, including a placebo group

Normal Saline

Placebo Comparator group

Description:

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

Treatment:

Drug: Normal saline

Lidocaine HCl

Active Comparator group

Description:

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

Treatment:

Drug: Lidocaine HCl