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

Phase 2

• Conditions: Postherpetic Neuralgia; Diabetic Polyneuropathy; Peripheral Neuropathy
• Interventions: Drug: Normal saline; Drug: Lidocaine HCl

• Registration Number: NCT02597257
• Lead Sponsor: Seoul National University Hospital

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.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-09-18
• Status Verified: 2015-11
• Study First Submitted QC: 2015-11-03
• Last Update Submitted: 2015-11-03
• Study First Posted: 2015-11-05
• Last Update Posted: 2015-11-05
• Primary Completion: 2016-07
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 44

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal Saline	Normal saline	* normal saline * total 250 ml * once a week * 4 times
Lidocaine HCl	Lidocaine HCl	* lidocaine 3 mg/kg mixed in normal saline * total 250 ml * once a week * 4 times

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Yong Chul Kim; 🇰🇷 Seoul, Korea, Republic of