Postoperative Analgesia With Buprenorphine Transdermal System (BTDS) Versus Tramadol for Postoperative Pain Control and Quality of Life After Spinal Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Pain intensity score : pain NRS scale
研究概览
简要总结
Major purpose of this research is to evaluate the effect and usefulness of Buprenorphine transdermal system (MTDS) among the patients with lumbar spinal disease who was performed the single-level posterior lumbar fusion.
After surgery, all the patients apply the patient-controlled analgesia. After three days of surgery, patients are divided into two groups.Group A is an experimental group that administer the BTDS after surgery, and Group B is a control group that take tramadol analgesics. If the patient's pain score exceeds the NRS 4, they can take the additional rescue medicine, acetaminophen.
After the surgery, patient's pain score and quality of life would be recorded sequentially. The time of recording is postoperative 36 hours, 72 hours, 7 days, 2 weeks, 4 weeks, and 3 months, respectively.
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
- Single (Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adults over 20 years
- •taking the lumbar spinal surgery : single-level, posterior fusion
- •stay in hospital more than 2 days after operation
排除标准
- •pregnancy or breast-feeding
- •allergy or contraindication to buprenorphine
- •patient with decreased lung function
- •patient with taking MAO inhibitor or anticonvulsant
- •patient with brain lesion, or severe liver disease
- •dependence in opioid drugs
- •taking muscle relaxant or tranquilizer
- •patient had taken buprenorphine preoperatively
- •taking strong opioids before enrolling the study
- •another severe source of pain except lumbar spine
- •severe cardiovascular, pulmonary, or renal compromised patients
研究组 & 干预措施
Buprenorphine
Buprenorphine group : They will apply 3 days after the spine operation.
干预措施: Buprenorphine (Drug)
Tramadol
Tramadol group : They will take a pill of tramadol analgesics.
干预措施: Tramadol (Drug)
结局指标
主要结局
Pain intensity score : pain NRS scale
时间窗: 3 months
We will estimate pain NRS scale at 36 hours, 72 hours, 7 days, 2 weeks, 4 weeks, and 3 months postoperatively.
次要结局
未报告次要终点
研究者
Jin S. Yeom
Professor
Seoul National University Hospital