The Effect of Ketamine Infusion for Reduction of Neuropathic Pain and Improvement of Quality of Life After Lumbar Surgery
试验速览
- 阶段
- 4 期
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Pain Scores on the Visual Analog Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Undergoing lumbar spine surgery due to back pain patients
- •American Physical Status Classification I or II
排除标准
- •less than 3 month of back pain
- •past history of operation at lumbar area
- •past history of glucoma, drug abuse, alcohol abuse
- •pregnancy
研究组 & 干预措施
ketamine
ketamine 0.5mg/kg loading dose and followed by 0.5mg/kg/h during operation
干预措施: Ketamine (Drug)
结局指标
主要结局
Pain Scores on the Visual Analog Scale
时间窗: 3 month after lumbar surgery
VAS score in 3 month after lumbar surgery
次要结局
- neuropathic pain scale (NPS) score(3 month after lumbar surgery)
- Leeds assessment of neuropathic symptoms and signs (LANSS) score(3 month after lumbar surgery)
- Oswestry disability index (ODI) score(3 month after lumbar surgery)
- WHO Quality of Life (WHOQOL-BREF) score(3 month after lumbar surgery)
研究者
Cholhee Park
Clinical assistant professor
Yonsei University