NCT02067338已完成4 期
The Effect of Epidural Low-dose Morphine-soaked Microfibrillar Collagen Sponge in Postoperative Pain Control After Posterior Lumbar Spinal Surgery: a Randomized, Double-blind, Placebo-controlled
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- VAS measurement was recorded at twenty-four hour after posterior lumbar spinal surgery then compare VAS between low-dose 1 mg morphine-soaked microfibrillar collagen sponge method with normal saline soked
研究概览
简要总结
The effect of epidural low-dose morphine-soaked microfibrillar collagen sponge in postoperative pain control after posterior lumbar spinal surgery: a randomized, double-blind, placebo-controlled study
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
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > 18 Yrs
- •Good orientation and communication
排除标准
- •opioids or sulfonamides allergy
- •Contraindication for use
- •Epidural morphine
- •Selective COX 2 inhibitor
- •Patient-controlled analgesia (PCA)
- •ASA class > 3
- •BMI ≥ 35 kg/sq.m.
- •Preoperative use of opioids within 6 Wks
- •Intraoperative bleeding > 1000ml
研究组 & 干预措施
normal saline
Placebo Comparator
During posterior lumbar spinal surgery,one group of patient received normal saline soaked collagen sponge.
干预措施: normal saline (Drug)
1 mg morphine soak in epidural oxidized cellulose
Active Comparator
During posterior lumbar spinal surgery ,Another group of patients received 1 mg morphine-soaked in epidural oxidized cellulose.
干预措施: 1 mg morphine soak in epidural oxidized cellulose (Drug)
结局指标
主要结局
VAS measurement was recorded at twenty-four hour after posterior lumbar spinal surgery then compare VAS between low-dose 1 mg morphine-soaked microfibrillar collagen sponge method with normal saline soked
时间窗: 2 years
次要结局
未报告次要终点
研究者
研究点 (1)
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