Long Term Outcome After Serial Lidocaine Infusion in Peripheral Neuropathic Pain

Study Overview
=================
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).

Official Title
-----------------
Long Term Outcome After Serial Lidocaine Infusion in Peripheral Neuropathic Pain : A Pilot Study

Conditions
-----------------
Peripheral Neuropathy

Intervention / Treatment
-----------------
* Drug: Lidocaine
* Drug: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo group<br>Normal Saline 50 ml intravenous infusion in 1 hour once a week 4 times | Drug: Placebo<br> <br> |
| Active Comparator: Lidocaine group<br>Lidocaine 3mg/kg in Normal Saline to 50 ml intravenous infusion in 1 hour once a week 4 times | Drug: Lidocaine<br>* Lidocaine 3 mg/kg dilute in Normal Saline to 50 ml intravenous infusion in 1 hour<br>* Other names: Intravenous lidocaine;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Pain intensity (Numerical Rating Scale; from 0-10) 0 means no pain, and 10 means worst pain imaginable. | at 3 months after serial lidocaine infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | at 3 month after serial lidocaine infusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peripheral neuropathy