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

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

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.

Study Overview

• Status: Unknown
• Conditions: Peripheral Neuropathy; Diabetic Polyneuropathy; Postherpetic Neuralgia
• Intervention / Treatment: Drug: Normal saline; Drug: Lidocaine HCl

Detailed Description

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

• Study Type: Interventional
• Enrollment (Anticipated): 44
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Yong Chul Kim
    • Contact: Yong Chul Kim, PhD; Phone Number: +82-2-2072-3289; Email: pain@snu.ac.kr
    • Sub-Investigator: Jee Youn Moon, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Collaborators: Ministry of Food and Drug Safety, Korea
• Investigators: Principal Investigator: Yong Chul Kim, PhD, Seoul National University Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Anticipated): July 1, 2016
• Study Completion (Anticipated): July 1, 2016

Study Registration Dates

• First Submitted: September 18, 2015
• First Submitted That Met QC Criteria: November 3, 2015
• First Posted (Estimate): November 5, 2015

Study Record Updates

• Last Update Posted (Estimate): November 5, 2015
• Last Update Submitted That Met QC Criteria: November 3, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: Lidocaine infusion therapy
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Neuralgia; Peripheral Nervous System Diseases; Polyneuropathies; Diabetic Neuropathies; Neuralgia, Postherpetic; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine
• Other Study ID Numbers: 1720150047