IRCT20230416057923N1尚未招募2 期
Comparing the efficacy of Pregabalin with Duloxetine in perioperative pain management in knee fractures surgery: A randomized, double-blind, clinical trial
适应症
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 68
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 years 至 80 years（—）
- 性别
- All
入选标准
- •Age 18 to 80 years
- •Patients with fractures around the knee who are hospitalized and undergo surgery
- •The patient is willing to participate in the study and sign the informed consent form.
排除标准
- •History of taking Duloxetine, Pregabalin and Gabapentin within two weeks before surgery
- •History of allergy to study drugs
- •Severe active infection leads to cognitive impairment
- •Severe renal failure (MDRD renal clearance less than 30 ml/min/1.73m2)
- •Severe liver failure (Child Pugh C or liver enzymes more than 5 times the maximum normal range)
- •Moderate to severe dependence (according to DSM5 criteria) to opioids or use within 24 hours before entering the study
- •BMI greater than or equal to 40 kg/m2
- •ASA Physical status IV/V
- •Use of epidural anesthesia in surgery
- •Pregnancy and breastfeeding
- •NPO patients
- •Active gastrointestinal ulcer
- •high risk of bleeding before or after surgery
- •Participate in another trial at the same time
- •Concomitant use of SNRI, TCA, MAOI, st john wort within two weeks before entering the study
- •Hemodynamic instability
- •Being a communication barrier with the patient to evaluate him
研究者
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