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

Sponsor

Seoul National University Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT02597257

Collaborator

Ministry of Food and Drug Safety, Korea (Other)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postherpetic Neuralgia Diabetic Polyneuropathy Peripheral Neuropathy	Drug: Lidocaine HCl Drug: Normal saline	Phase 2

Detailed Description

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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

44 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Aug 1, 2015

Anticipated Primary Completion Date :

Jul 1, 2016

Anticipated Study Completion Date :

Jul 1, 2016

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

11-point Numeric Rating Scale [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 Outcome Measures

Brief Pain Inventory Short Form [at the end of intervention and 4 weeks after the end of intervention]
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]
Shot Form McGill Pain Questionnaire [at the end of intervention and 4 weeks after the end of intervention]
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)
Patient Global Impression of Change [at the end of intervention and 4 weeks after the end of intervention]
7-point scale from very much improved to very much worse
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)]
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)
11-point Numeric Rating Scale [4 weeks after the end of intervention]
Rating averaged daily pain score over a 7-day period, 0=on pain to 10=worst possible pain

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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