Peripheral Neuropathy
Conditions
Keywords
Peripheral neuropathy
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).
Interventions
DRUGLidocaine
Lidocaine 3 mg/kg dilute in Normal Saline to 50 ml intravenous infusion in 1 hour
DRUGPlacebo
Sponsors
Mahidol University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity | at 3 months after serial lidocaine infusion | Pain intensity (Numerical Rating Scale; from 0-10) 0 means no pain, and 10 means worst pain imaginable. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life using Utility score | at 3 month after serial lidocaine infusion | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Psychological effects on depression, anxiety and stress | at 3 month after serial lidocaine infusion | 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. |
Countries
Thailand
Outcome results
None listed