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

Peripheral Neuropathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02597257
• Other study ID #: 1720150047
• Status: Recruiting
• Phase: Phase 2
• First received: September 18, 2015
• Last updated: November 3, 2015
• Start date: August 2015
• Est. completion date: July 2016

Study information

• Verified date: November 2015
• Source: Seoul National University Hospital
• Contact: Yong Chul Kim
• Phone: +82-2-2072-3289
• Email: pain[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 44
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Diabetic Polyneuropathy
• Neuralgia
• Neuralgia, Postherpetic
• Peripheral Nervous System Diseases
• Peripheral Neuropathy
• Polyneuropathies
• Postherpetic Neuralgia

Intervention

Drug:
• Lidocaine HCl
lidocaine continuous infusion
• Normal saline
Normal saline continuous infusion

Locations

Country	Name	City	State
Korea, Republic of	Yong Chul Kim	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Ministry of Food and Drug Safety, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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)	Yes
Secondary	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	No