NCT06807866招募中4 期
Use of Duloxetine for Perioperative Pain Control After Total Hip Arthroplasty: Randomized Controlled Clinical Trial (RCT)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Total Milligram Morphine Equivalent (MME)
研究概览
简要总结
The primary objective of this study is to compare total narcotic intake standardized via milligram morphine equivalents between duloxetine and placebo cohorts after a total hip arthroplasty.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients > 18 years of age
- •Patients undergoing primary total hip arthroplasty
- •Ambulatory patient prior to fracture
- •Subjects must be capable of providing informed consent
- •English or Spanish speaking
排除标准
- •Previous hemiarthroplasty or THA on ipsilateral hip
- •History of Complex Regional Pain Syndrome in ipsilateral extremity
- •History of demyelinating disorder or neurologic deficit that may contribute to altered pain tolerance or sensation
- •Acute or chronic hip infection in ipsilateral extremity
- •Pregnant or breastfeeding
- •Open fracture
- •Polytrauma
- •Intravenous or drug users within 6 months of surgery
- •Liver Failure via clinical diagnosis or international normalized ratio greater than 1.5 or partial thromboplastin time greater than 40
- •Patients on selective serotonin reuptake inhibitor, serotonin norepinephrine reuptake inhibitor, monoamine oxidase inhibitor, and/or tricyclic anti-depressant
- •Severe renal dysfunctions, such as glomerular filtration rate less than 30
- •Moderate to severe depression as diagnosed by a clinician
- •Taking cytochrome P450 1A2 inhibitors and cytochrome P450 1A6 inhibitors for the duration of 5 half-lives as these drugs are clinically eliminated within 5 half-lives
- •History of uncontrolled narrow angle glaucoma
研究组 & 干预措施
Placebo group
Placebo Comparator
Participants will be in this group for up to 2 hours.
干预措施: Placebo (Other)
Duloxetine group
Experimental
Participants will be in this group for up to 2 hours.
干预措施: Duloxetine (Drug)
结局指标
主要结局
Total Milligram Morphine Equivalent (MME)
时间窗: Up to 24 hours
The primary outcome measure was milligram morphine equivalent units to measure pain intensity difference and total pain relief
次要结局
- Change in Pain as measured by Visual Analog Scale (VAS)(Baseline, up to 24 hours, 3 months)
- Musculoskeletal function as measured by SMFA questionnaire(Up to 3 months)
- Hospital Length of stay measured in hours(Up to 96 hours)
- Ambulation distance measured by meters(Up to 3 months)
研究者
Victor Hugo Hernandez
Professor
University of Miami
研究点 (1)
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