Comparison Efficacy of Mirogabalin and Pregabalin in Total Knee Arthroplasty. a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Pain score
研究概览
简要总结
The goal of this RCT is to compare efficacy between mirogabalin and pregabalin in pain reducing after unilateral primary total knee arthroplasty.
The main question[s] it aims to answer are:
• Does mirogabalin have better pain reduction than pregabalin after unilateral primary total knee arthroplasty.
Participants will randomized to mirogabalin or pregabalin group and will take the drug for 2 weeks after TKA. Researchers will compare to pregabalin group to see pain and functional outcomes after TKA.
详细描述
After surgery is complete, you will be randomly assigned to receive painkillers Mirogabalin or Pregabalin along with other standard medications.
Surgery by Mirogabalin group: Participants received 5 mg of mirogabalin, one tablet taken twice a day, after breakfast and dinner, for 2 weeks.
In the pregabalin group: Participants received 75 mg of pregabalin, one tablet taken daily before bedtime, for 2 weeks.
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
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 50-85 years old
- •Unilateral primary osteoarthritis undergoing primary TKA
排除标准
- •GFR <60
- •Allergy to drug in this study
- •Cannot underwent spinal anesthesia and adductor canal block
- •Taking gabapentinoid within 3 months before surgery
- •History of previous knee surgery
- •Severe liver disease
研究组 & 干预措施
Pregabalin
Participants will receive 75 mg of pregabalin, once a day before bedtime, for 2 weeks.
干预措施: Pregabalin (Drug)
Mirogabalin
Participants will receive 5 mg of mirogabalin, twice a day, after breakfast and dinner, for 2 weeks.
干预措施: Mirogabalin (Drug)
结局指标
主要结局
Pain score
时间窗: Every 6 hours after surgery for 2 days, then twice a day for 2 weeks, then once a week until 12 week after surgery.
Visual analog scale at rest and motion (0-100 points, 0 mean best, 100 mean worst)
次要结局
- Morphine consumption(72 hours after surgery)
- Sedation score(24 hour, 48 hour, 2 week, 6 week and 12 week after surgery)
- Range of motion(24 hour, 48 hour, 2 week, 6 week and 12 week after surgery)
- Knee society score(2 week, 6 week and 12 week after surgery)
- Incidence of Somnolence and dizziness(everyday until 14 days then once a week until 12 weeks after surgery)
- Total hospital stay(up to 1 week)
- Knee injury and Osteoarthritis Outcome Score (KOOS)(2 week, 6 week and 12 week after surgery)
研究者
Yot Tanariyakul
Principle investigator
Thammasat University Hospital