Postherpetic Neuralgia, Diabetic Polyneuropathy, Peripheral Neuropathy
Conditions
Keywords
Lidocaine infusion therapy
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.
Interventions
DRUGLidocaine HCl
lidocaine continuous infusion
DRUGNormal saline
Normal saline continuous infusion
Sponsors
Ministry of Food and Drug Safety, Korea
Seoul National University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 11-point Numeric Rating Scale | 1 week after the end of intervention | Rating averaged daily pain score over a 7-day period, 0=on pain to 10=worst possible pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brief Pain Inventory Short Form | at the end of intervention and 4 weeks after the end of intervention | 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 | at the end of intervention and 4 weeks after the end of intervention | 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 | at the end of intervention and 4 weeks after the end of intervention | 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 | through the study completion (7 weeks) | 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 | 4 weeks after the end of intervention | Rating averaged daily pain score over a 7-day period, 0=on pain to 10=worst possible pain |
Countries
South Korea
Contacts
Primary ContactYong Chul Kim
Outcome results
None listed