The Effect of Pregabalin and Dexamethasone on Acute and Chronic Pain After Lumbar Spinal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- the multimodal analgesic effect of pregabalin, and of pregabalin with dexamethasone
研究概览
简要总结
Multimodal analgesia may be important for optimal postoperative pain treatment and facilitation of early mobilization and recovery. This study investigated the analgesic effect of pregabalin and dexamethasone in patients undergoing lumbar spinal surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Double (Care Provider, Investigator)
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
- 是
入选标准
- •patients scheduled for lumbar spinal surgery, aged 20 to 70 years, with a body mass index (BMI) from 18 to 32 and an American Society of Anesthesiologists (ASA)physical status classification of I-II were eligible for the study.
排除标准
- •allergy to any drugs in the study
- •alcohol and/or drug abuse
- •treatment with antacids or antidepressants
- •a history of diabetes or epilepsy
- •a daily intake of analgesics or an intake of any analgesic within 24 h before surgery
- •treatment with systemic glucocorticoids within 4 weeks before surgery
- •known impaired hepatic and renal function.
研究组 & 干预措施
placebo arm
干预措施: placebo (Drug)
pregabalin arm
干预措施: Pregabalin (Drug)
dexamethasone with pregabalin arm
干预措施: dexamethasone (Drug)
结局指标
主要结局
the multimodal analgesic effect of pregabalin, and of pregabalin with dexamethasone
时间窗: Assessment was performed during the first 72 hour following emergence from general anesthesia, subdivided into 5 time periods; on arrival of patient to the PACU, 1-6 hour, 6-24 hour, 24-48 hour and 48-72 hour
Primary Outcome is to investigate the multimodal analgesic effect of pregabalin, and of pregabalin with dexamethasone, in patients receiving a patient-controlled analgeisa with fentanyl, on fentanyl consumption (primary end point), pain scores and side effects in patients scheduled for lumbar spinal surgery.
次要结局
未报告次要终点