Effects of Pre-operative Oral Pregabalin on Post Operative Morphine Consumption After Abdominal Hysterectomy With/Without Salpingo-oophorectomy Under Spinal Anesthesia With Intrathecal Morphine
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 125
- 试验地点
- 1
- 主要终点
- Post Operative Morphine Consumption
研究概览
简要总结
This study aims to compare the effect of pre-operative oral pregabalin on post operative morphine consumption after abdominal hysterectomy with/without salpingo-oophorectomy.
详细描述
The participants are randomized into two groups by computer randomization. The patient undergo spinal anesthesia with 0.5% Heavy bupivacaine with morphine 0.2 mg. IV PCA morphine is initiate in the post-anesthetic care unit. We compare post operative morphine consumption in the first 24 hours, time to first analgesia, adverse event, and patient satisfaction.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA classification 1-2 undergoing abdominal hysterectomy with/without salpingo-oophorectomy under spinal anesthesia with intrathecal morphine
- •Patient can use patient-controlled analgesia (IV PCA)
排除标准
- •History of drug allergy to gabapentinoid and related drug
- •History of regular analgesic drug use, psychiatric drug usage, drug abuse, alcohol addiction or chronic pain patient
- •Renal disease (Creatinine Clearance < 60), Liver disease, Seizure disorder and Psychiatric disorder
研究组 & 干预措施
Placebo
Placebo in capsule is prescribed to the patient 60 min prior to the surgery.
干预措施: placebo (Drug)
Pregabalin
Pregabalin (150 mg) one capsule is prescribed to the patient 60 min prior to the surgery.
干预措施: Pregabalin (Drug)
结局指标
主要结局
Post Operative Morphine Consumption
时间窗: 6, 12, and 24 hours after operation
Cumulative morphine consumption in the first 24 hours is recorded from IV PCA
次要结局
- Time to First Analgesia(24 hours)
- Pain Scores on the Visual Analog Scale(24 hours)
- Numbers of Participants With Adverse Events as a Measure of Safety and Tolerability(24 hours)
- Number of Patients Evaluating Their Satisfaction(24 hours)