Comparison of Perioperative Outcome Between Corticosteroids and Placebo in Transforaminal Endoscopic Lumbar Discectomy. A Single-center Randomized Placebo-controlled Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Post-operative morphine consumption
研究概览
简要总结
The endoscopic discectomy has rapidly developed and increased need by patients. This procedure is widely performed by interventional pain physicians as well as by spine surgeons because it requires no general anesthesia or admission to a hospital. Many studies were reported that corticosteroid injection can inhibit persistent postoperative pain in lumbar discectomy. However, data of perioperative epidural steroids after an endoscopic discectomy is lacking.
详细描述
To examine whether corticosteroid administered epidural space in patients undergoing endoscopic lumbar discectomy reduces postoperative morphine consumption, back and leg pain relief, improves functional disability comparing to placebo
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 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Lumbar disc herniation patient age 20-45 year-old who have symptom duration was at least 6 weeks and conservative treatment failed
排除标准
- •Refuse to participate and inform consent, Previous spinal surgery, History of allergic to steroid
研究组 & 干预措施
placebo injection
no injection agent
干预措施: Placebos (Drug)
epidural steroid injection
40 mg triamcinolone acetate 1 cc
干预措施: 40 mg Triamcinolone acetate 1 cc (Drug)
结局指标
主要结局
Post-operative morphine consumption
时间窗: Post operative 24 hour of morphine consumption in mg
次要结局
- Visual analog score (back and leg) 0-10(1 day, 2, 6 ,12, 24 weeks)
- Oswestry disability index (ODI(2, 6 ,12, 24 weeks)
- MacNab scores(2, 6 ,12, 24 weeks)
研究者
Jatupon Kongtharvonskul
principle investigator
Ramathibodi Hospital