The Effect of Ketamine Infusion on Lumbar Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Ketamine Infusion for Reduction of Neuropathic Pain and Improvement of Quality of Life After Lumbar Surgery

Conditions
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Chronic Low Back Pain

Intervention / Treatment
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* Drug: Ketamine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Undergoing lumbar spine surgery due to back pain patients American Physical Status Classification I or II Exclusion Criteria: less than 3 month of back pain past history of operation at lumbar area past history of glucoma, drug abuse, alcohol abuse pregnancy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ketamine<br>ketamine 0.5mg/kg loading dose and followed by 0.5mg/kg/h during operation | Drug: Ketamine<br>* ketamine 0.5mg/kg loading followed by 0.5mg/kg/h infusion during operation<br>* Other names: Huons ketamine hch injection;|
| Placebo Comparator: Placebo<br>normal saline 0.5mg/kg loading dose and followed by 0.5mg/kg/h during operation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |