Efficacy and Side Effect Profile of Varying Dose of Pregabalin for the Treatment of Acute Postoperative Pain Following Spinal Surgery
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 132
- 主要终点
- Rescue analgesic usage
研究概览
简要总结
The objective of this study is to examine the efficacy and side effect of varying dose of pregabalin for the treatment of postoperative pain after spinal surgery.
详细描述
Patients experience considerable postoperative pain after spine surgery. Because the spine is located at the center of the body and supports body weight, severe postoperative pain hinders upper body elevation and gait which can lead to various complications such as pulmonary deterioration or pressure sores. It is important to effectively control postoperative pain to prevent such complications. Gabanoids are widely used as preemptive multimodal analgesia while their effects and side effects are known to be dose dependent. The objective of this study is to examine the efficacy and side effect of varying dose of pregabalin for the treatment of postoperative pain after spinal surgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient undergoing spine surgery at out institution for degenerative lumbar disorder.
排除标准
- •ASA classification over 2
- •Patients with dizziness or frequent headache
- •Active alcohol or drug usage
- •Intake of any analgesics daily or 48 hours before surgery
- •Impaired renal and/or hepatic function
- •Diagnosed and being treated for anxiety or depression disorders
- •Coverage from worker's compensation insurance or car insurance.
研究组 & 干预措施
Placebo
3 capsules of placebo drug are administered once prior to surgery and every 12 hours after surgery for 72 hours
干预措施: Placebo (Drug)
Pregabalin 25mg
1 capsule of Kabalin 25mg Cap and 2 pills of placebo drug are administered once prior to surgery and every 12 hours after surgery for 72 hours
干预措施: Pregabalin 25 MG (Drug)
Pregabalin 25mg
1 capsule of Kabalin 25mg Cap and 2 pills of placebo drug are administered once prior to surgery and every 12 hours after surgery for 72 hours
干预措施: Placebo (Drug)
Pregabalin 50mg
2 capsules of Kabalin 25mg Cap and 1 pill of placebo drug are administered once prior to surgery and every 12 hours after surgery for 72 hours
干预措施: Pregabalin 25 MG (Drug)
Pregabalin 50mg
2 capsules of Kabalin 25mg Cap and 1 pill of placebo drug are administered once prior to surgery and every 12 hours after surgery for 72 hours
干预措施: Placebo (Drug)
Pregabalin 75mg
3 capsules of Kabalin 25mg Cap are administered once prior to surgery and every 12 hours after surgery for 72 hours
干预措施: Pregabalin 25 MG (Drug)
结局指标
主要结局
Rescue analgesic usage
时间窗: 72hours after surgery
Frequency of rescue analgesic administered
IV PCA usage
时间窗: 72hours after surgery
amount of infused fentanyl-based intravenous patient-controlled analgesia (PCA)
Pain intensity
时间窗: 72hours after surgery
Change of Visual analogue scale (VAS) pain score
次要结局
- Nausea and vomiting due to IV PCA usage(From arrival at general ward after sugery for 72 hours, subdivided into 4 periods (1-6hours, 6-24hours, 24-48hours, 48-72hours))
研究者
Han Dong Lee
Assistant Professor
Ajou University School of Medicine