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Long Term Outcome After Serial Lidocaine Infusion in Peripheral Neuropathic Pain

Primary Purpose

Peripheral Neuropathy

Status
Completed
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
Lidocaine
Placebo
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Neuropathy focused on measuring Peripheral neuropathy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Peripheral neuropathic pain from peripheral nerve injury within 6 months after injury
  • Well understand to Thai language in writing or listening

Exclusion Criteria:

  • Underlying Heart disease or Arrhythmia
  • Allergy to lidocaine, Gabapentin, Carbamazepine, tramadol
  • History of epilepsy
  • History of lidocaine used
  • Underlying Psychiatric disease
  • History of drug abuse
  • Pregnancy and nursing

Sites / Locations

  • Faculty of medicine Siriraj Hospital Mahidol University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo group

Lidocaine group

Arm Description

Normal Saline 50 ml intravenous infusion in 1 hour once a week 4 times

Lidocaine 3mg/kg in Normal Saline to 50 ml intravenous infusion in 1 hour once a week 4 times

Outcomes

Primary Outcome Measures

Pain intensity
Pain intensity (Numerical Rating Scale; from 0-10) 0 means no pain, and 10 means worst pain imaginable.

Secondary Outcome Measures

Quality of life using Utility score
Quality of life will be assessed using EuroQol5D5L and reported as a utility score (0-1.0) "0" represents death, and "0.1" means full health

Full Information

First Posted
August 13, 2014
Last Updated
November 24, 2022
Sponsor
Mahidol University
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1. Study Identification

Unique Protocol Identification Number
NCT02217267
Brief Title
Long Term Outcome After Serial Lidocaine Infusion in Peripheral Neuropathic Pain
Official Title
Long Term Outcome After Serial Lidocaine Infusion in Peripheral Neuropathic Pain : A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2014 (undefined)
Primary Completion Date
December 29, 2017 (Actual)
Study Completion Date
February 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study to evaluated Long term outcome after serial Lidocaine infusion when compared with placebo in peripheral neuropathic pain patients in acute stage (less than 6 months) at 3 months after first time of infusion
Detailed Description
Peripheral nerve injury may give rise to severe and long-lasting types of pains which are often resistant to treatment such as opioid, tricyclic antidepressant or anticonvulsant. Lidocaine infusion has been the one of intractable neuropathic pain treatment . My hypothesis the serial lidocaine infusion can adequate pain control and can prevent chronic pain (central sensitisation). Therefore, we designed this prospective, randomised, double-blind, controlled study to evaluate the efficacy of serial lidocaine infusion in peripheral neuropathic pain compared with placebo in long term outcome (at 3 month).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Neuropathy
Keywords
Peripheral neuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Normal Saline 50 ml intravenous infusion in 1 hour once a week 4 times
Arm Title
Lidocaine group
Arm Type
Active Comparator
Arm Description
Lidocaine 3mg/kg in Normal Saline to 50 ml intravenous infusion in 1 hour once a week 4 times
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Other Intervention Name(s)
Intravenous lidocaine
Intervention Description
Lidocaine 3 mg/kg dilute in Normal Saline to 50 ml intravenous infusion in 1 hour
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Pain intensity
Description
Pain intensity (Numerical Rating Scale; from 0-10) 0 means no pain, and 10 means worst pain imaginable.
Time Frame
at 3 months after serial lidocaine infusion
Secondary Outcome Measure Information:
Title
Quality of life using Utility score
Description
Quality of life will be assessed using EuroQol5D5L and reported as a utility score (0-1.0) "0" represents death, and "0.1" means full health
Time Frame
at 3 month after serial lidocaine infusion
Other Pre-specified Outcome Measures:
Title
Psychological effects on depression, anxiety and stress
Description
The psychological effect will be assessed using DASS21. Each of these domains is assessed with a separate 7-item scale. Responses to the items are summed to create scales with a total possible score of 21 points, then multiplied by two to calculate the final score. The final score can then be graded in each domain: Normal (0-4), Mild (5-6), Moderate (7-11), Severe (11-13), and Extremely Severe (14+) for depression; Normal (0-3), Mild (4-5), Moderate (6-7), Severe (8-9) and Extremely Severe (10+) for anxiety; and Normal (0-7), Mild (8-9), Moderate (10-12), Severe (13-16) and Extremely Severe (14+) for stress.
Time Frame
at 3 month after serial lidocaine infusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Peripheral neuropathic pain from peripheral nerve injury within 6 months after injury Well understand to Thai language in writing or listening Exclusion Criteria: Underlying Heart disease or Arrhythmia Allergy to lidocaine, Gabapentin, Carbamazepine, tramadol History of epilepsy History of lidocaine used Underlying Psychiatric disease History of drug abuse Pregnancy and nursing
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suratsawadee Wangnamthip, M.D.
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of medicine Siriraj Hospital Mahidol University
City
Bangkoknoi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
16235318
Citation
Challapalli V, Tremont-Lukats IW, McNicol ED, Lau J, Carr DB. Systemic administration of local anesthetic agents to relieve neuropathic pain. Cochrane Database Syst Rev. 2005 Oct 19;2005(4):CD003345. doi: 10.1002/14651858.CD003345.pub2.
Results Reference
result
PubMed Identifier
14745057
Citation
Attal N, Rouaud J, Brasseur L, Chauvin M, Bouhassira D. Systemic lidocaine in pain due to peripheral nerve injury and predictors of response. Neurology. 2004 Jan 27;62(2):218-25. doi: 10.1212/01.wnl.0000103237.62009.77.
Results Reference
result
PubMed Identifier
9415498
Citation
Kingery WS. A critical review of controlled clinical trials for peripheral neuropathic pain and complex regional pain syndromes. Pain. 1997 Nov;73(2):123-139. doi: 10.1016/S0304-3959(97)00049-3.
Results Reference
result
PubMed Identifier
8857633
Citation
Wallace MS, Dyck BJ, Rossi SS, Yaksh TL. Computer-controlled lidocaine infusion for the evaluation of neuropathic pain after peripheral nerve injury. Pain. 1996 Jul;66(1):69-77. doi: 10.1016/0304-3959(96)02980-6.
Results Reference
result
Links:
URL
http://www.si.mahidol.ac.th/th/division/sirb/
Description
Siriraj Institutional Review Board

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Long Term Outcome After Serial Lidocaine Infusion in Peripheral Neuropathic Pain

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