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The purpose of this study is to evaluate the effect of ketamine infusion for reduction of neuropathic pain and improvement of quality of life after lumbar surgery.
Neuropathic pain defined as 'pain caused by a lesion or disease of the somatosensory system'. Neuropathic pain is 20 - 35% of low back pain.
Ketamine is categorized as N-methyl D-aspartate receptor antagonist. Ketamine has an analgesic effect in low dose and anesthetic effect in relative high dose. Also, ketamine is used in chronic neuropathic pain as postherpetic neuralgia., phantom pain, central neuropathic pain, complex regional pain syndrome, ischemic pain.
In this study, ketamine will be infused during lumbar surgery in randomized, double-blind and double-blind parallel group control trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ketamine | Experimental | ketamine 0.5mg/kg loading dose and followed by 0.5mg/kg/h during operation |
|
| Placebo | Placebo Comparator | normal saline 0.5mg/kg loading dose and followed by 0.5mg/kg/h during operation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine | Drug | ketamine 0.5mg/kg loading followed by 0.5mg/kg/h infusion during operation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores on the Visual Analog Scale | VAS score in 1 day before lumbar surgery | 1 day before lumbar surgery |
| Pain Scores on the Visual Analog Scale | VAS score in 1 month after lumbar surgery | 1 month after lumbar surgery |
| Pain Scores on the Visual Analog Scale | VAS score in 3 month after lumbar surgery | 3 month after lumbar surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Leeds assessment of neuropathic symptoms and signs (LANSS) score | LANSS score in 1 day before lumbar surgery | 1 day before lumbar surgery |
| Leeds assessment of neuropathic symptoms and signs (LANSS) score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kyung Hyun Kim, MD | Contact | 82-02-2019-3401 | NSKHK@yuhs.ac | |
| Cholhee Park, MD | Contact | 82-02-2019-6079 | chairp@yuhs.ac |
| Name | Affiliation | Role |
|---|---|---|
| Kyung Hyun Kim, MD | Department of Neurosurgery, The Spine and Spinal Cord Institute, Gangnam Severance Spine Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gangnam Severance Hospital | Recruiting | Seoul | 135-720 | South Korea |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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LANSS score in 1 month after lumbar surgery
| 1 month after lumbar surgery |
| Leeds assessment of neuropathic symptoms and signs (LANSS) score | LANSS score in 3 month after lumbar surgery | 3 month after lumbar surgery |
| neuropathic pain scale (NPS) score | NPS score in 1 day before lumbar surgery | 1 day before lumbar surgery |
| neuropathic pain scale (NPS) score | NPS score in 1 month after lumbar surgery | 1 month after lumbar surgery |
| neuropathic pain scale (NPS) score | NPS score in 3 month after lumbar surgery | 3 month after lumbar surgery |
| Oswestry disability index (ODI) score | ODI score in 1 day before lumbar surgery | 1 day before lumbar surgery |
| Oswestry disability index (ODI) score | ODI score in 1 month after lumbar surgery | 1 month after lumbar surgery |
| Oswestry disability index (ODI) score | ODI score in 3 month after lumbar surgery | 3 month after lumbar surgery |
| WHO Quality of Life (WHOQOL-BREF) score | WHOQOL-BREF score in 1 day before lumbar surgery | 1 day before lumbar surgery |
| WHO Quality of Life (WHOQOL-BREF) score | WHOQOL-BREF score in 1 month after lumbar surgery | 1 month after lumbar surgery |
| WHO Quality of Life (WHOQOL-BREF) score | WHO Quality of Life (WHOQOL-BREF) score in 3 month after lumbar surgery | 3 month after lumbar surgery |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |