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

Primary Purpose

Postherpetic Neuralgia, Diabetic Polyneuropathy, Peripheral Neuropathy

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Lidocaine HCl
Normal saline
Sponsored by
Seoul National University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postherpetic Neuralgia focused on measuring Lidocaine infusion therapy

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Yong Chul KimRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Normal Saline

Lidocaine HCl

Arm Description

normal saline total 250 ml once a week 4 times

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

Outcomes

Primary Outcome Measures

11-point Numeric Rating Scale
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
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
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
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
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
Rating averaged daily pain score over a 7-day period, 0=on pain to 10=worst possible pain

Full Information

First Posted
September 18, 2015
Last Updated
November 3, 2015
Sponsor
Seoul National University Hospital
Collaborators
Ministry of Food and Drug Safety, Korea
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1. Study Identification

Unique Protocol Identification Number
NCT02597257
Brief Title
Efficacy and Safety of Lidocaine Infusion Treatment in Management of Neuropathic Pain
Official Title
Efficacy and Safety of Lidocaine Infusion Treatment in Management of Neuropathic Pain: Randomized, Controlled, Comparative Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
July 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
Collaborators
Ministry of Food and Drug Safety, Korea

4. Oversight

Data Monitoring Committee
Yes

5. 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.
Detailed Description
The investigators expect pain improvement after treatment with 3 mg/kg of lidocaine, continuously infused in normal saline 250 ml.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postherpetic Neuralgia, Diabetic Polyneuropathy, Peripheral Neuropathy
Keywords
Lidocaine infusion therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Normal Saline
Arm Type
Placebo Comparator
Arm Description
normal saline total 250 ml once a week 4 times
Arm Title
Lidocaine HCl
Arm Type
Active Comparator
Arm Description
lidocaine 3 mg/kg mixed in normal saline total 250 ml once a week 4 times
Intervention Type
Drug
Intervention Name(s)
Lidocaine HCl
Other Intervention Name(s)
183903BIJ, Lidocaine HCl inj. 2% DAEHAN PHARM. CO., LTD.
Intervention Description
lidocaine continuous infusion
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
228714BIJ, ISOTONIC SODIUM CHLORIDE DAEHAN PHARM. CO., LTD.
Intervention Description
Normal saline continuous infusion
Primary Outcome Measure Information:
Title
11-point Numeric Rating Scale
Description
Rating averaged daily pain score over a 7-day period, 0=on pain to 10=worst possible pain
Time Frame
1 week after the end of intervention
Secondary Outcome Measure Information:
Title
Brief Pain Inventory Short Form
Description
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]
Time Frame
at the end of intervention and 4 weeks after the end of intervention
Title
Shot Form McGill Pain Questionnaire
Description
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)
Time Frame
at the end of intervention and 4 weeks after the end of intervention
Title
Patient Global Impression of Change
Description
7-point scale from very much improved to very much worse
Time Frame
at the end of intervention and 4 weeks after the end of intervention
Title
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
Description
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)
Time Frame
through the study completion (7 weeks)
Title
11-point Numeric Rating Scale
Description
Rating averaged daily pain score over a 7-day period, 0=on pain to 10=worst possible pain
Time Frame
4 weeks after the end of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yong Chul Kim
Phone
+82-2-2072-3289
Email
pain@snu.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yong Chul Kim, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yong Chul Kim
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yong Chul Kim, PhD
Phone
+82-2-2072-3289
Email
pain@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
Jee Youn Moon, PhD

12. IPD Sharing Statement

Citations:
PubMed Identifier
29381569
Citation
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.
Results Reference
derived

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

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