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| Name | Class |
|---|---|
| Ministry of Food and Drug Safety, Korea | OTHER_GOV |
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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.
The investigators expect pain improvement after treatment with 3 mg/kg of lidocaine, continuously infused in normal saline 250 ml.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal Saline | Placebo Comparator |
|
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| Lidocaine HCl | Active Comparator |
|
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine HCl | Drug | lidocaine continuous infusion |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 11-point Numeric Rating Scale | Rating averaged daily pain score over a 7-day period, 0=on pain to 10=worst possible pain | 1 week after the end of intervention |
| Measure | Description | Time Frame |
|---|---|---|
| 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] | at the end of intervention and 4 weeks after the end of intervention |
| Shot Form McGill Pain Questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yong Chul Kim | Contact | +82-2-2072-3289 | pain@snu.ac.kr |
| Name | Affiliation | Role |
|---|---|---|
| Yong Chul Kim, PhD | Seoul National University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yong Chul Kim | Recruiting | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29381569 | Derived | 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. |
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| ID | Term |
|---|---|
| D051474 | Neuralgia, Postherpetic |
| D003929 | Diabetic Neuropathies |
| D010523 | Peripheral Nervous System Diseases |
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D036881 | Long-Term Synaptic Depression |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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| Normal saline | Drug | Normal saline continuous infusion |
|
|
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) |
| at the end of intervention and 4 weeks after the end of intervention |
| Patient Global Impression of Change | 7-point scale from very much improved to very much worse | at the end of intervention and 4 weeks after the end of intervention |
| 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) | through the study completion (7 weeks) |
| 11-point Numeric Rating Scale | Rating averaged daily pain score over a 7-day period, 0=on pain to 10=worst possible pain | 4 weeks after the end of intervention |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| Aniline Compounds |
| D000588 | Amines |
| D009473 | Neuronal Plasticity |
| D009424 | Nervous System Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |