NCT05938088招募中不适用
Mirogabalin and Pain After Total Hip Arthroplasty: a Double-blind, Randomized, Placebo-controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- numeric rating scale at flexion
研究概览
简要总结
The purpose of this study is to confirm the analgesic effect of mirogabalin in patients undergoing unilateral hip arthroplasty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 19 years of age or older who are expected to undergo unilateral hip arthroplasty
- •American Society of Anesthesiologists class 1-3
排除标准
- •Major prior ipsilateral open hip surgery
- •Allergies to drugs used in research
- •Difficult to manage diabetes mellitus (including insulin dependence)
- •Chronic use of gabapentin or pregabalin (regular use for more than 3 months)
- •Patients taking cimetidine, probenecid, or lorazepam
- •Patients with moderate or severe hepatic impairment (AST/ALT 2.5 times or more of the upper limit of normal)
- •Estimated glomerular filtration rate < 60 mL/min/1.73m2
- •Dependence on opioids
- •In the case of subjects who cannot read the consent form (e.g. illiterate, foreigners, etc.)
研究组 & 干预措施
placebo group
Sham Comparator
placebo
干预措施: Arm II (placebo group) (Drug)
mirogabalin group
Experimental
perioperative mirogabalin
干预措施: Arm I (mirogabalin group) (Drug)
结局指标
主要结局
numeric rating scale at flexion
时间窗: postoperative day 1
A score of 0 indicates no pain and a score of 10 indicates maximum pain.
次要结局
- numeric rating scale at flexion(up to 3 month after surgery)
研究者
Do-Hyeong Kim
Associate Professor
Gangnam Severance Hospital
研究点 (1)
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