Melatonin Use After Primary Total Joint Arthroplasty: A Randomized, Double Blind Placebo-Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 294
- 试验地点
- 1
- 主要终点
- Change in Sleep Disturbance as Measured by Epworth Sleep Score (ESS)
研究概览
简要总结
The purpose of this study is to determine the effect of melatonin supplementation on patient sleep quality, length of stay, and opioid consumption following primary, unilateral, elective total hip or knee arthroplasty.
详细描述
This will be a single-center randomized double blind placebo control clinical trial. In the cohort of patients undergoing primary elective total hip and the cohort of patients undergoing primary elective knee arthroplasty, participants are recruited from those who are willing to consent and participate in the study, and will be randomly 1:1 divided into intervention group and placebo group.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient are current candidates for elective primary total hip and total knee arthroplasty.
- •Patients ≥18 years of age but ≤ 95
- •Patients have been medically cleared and scheduled for surgery
排除标准
- •Non-elective conversion arthroplasty
- •Bilateral total joint arthroplasty
- •Contraindications to use of melatonin (diabetes, calcium channel blocker use, depression)
- •Conditions and medications likely to confound results due to impact on subjective and/or objective sleep quality (insomnia, drug/alcohol abuse, and use of benzodiazepines, and prescription sleep aids)
- •Conditions likely to impair capacity to adhere to protocol (mental impairment, psychiatric disorders other than anxiety/depression)
研究组 & 干预措施
Knee cohort
In the cohort of patients undergoing primary elective knee arthroplasty, participants are recruited from those who are willing to consent and participate in the study, and will be randomly recruited into intervention group. Intervention group will receive a 5mg Melatonin prescription for 14 days
干预措施: Melatonin 5 mg (Drug)
Knee cohort control
In the cohort of patients undergoing primary elective knee arthroplasty, participants are recruited from those who are willing to consent and participate in the study, and will be randomly recruited into placebo group. Control group will receive a placebo pill for 14 days
干预措施: Placebo (Other)
Hip cohort
In the cohort of patients undergoing primary elective total hip, participants are recruited from those who are willing to consent and participate in the study, and will be randomly recruited into intervention group. Intervention group will receive a 5mg Melatonin prescription for 14 days
干预措施: Melatonin 5 mg (Drug)
Hip cohort control
In the cohort of patients undergoing primary elective total hip, participants are recruited from those who are willing to consent and participate in the study, and will be randomly recruited into placebo group. Control group will receive a placebo pill for 14 days
干预措施: Placebo (Other)
结局指标
主要结局
Change in Sleep Disturbance as Measured by Epworth Sleep Score (ESS)
时间窗: Visit 1 (Screening Visit), Visit 2 (2 months post surgery)
The primary objective is the Epworth Sleep Score used to evaluate the impact of melatonin use on the quality of sleep, including total hours of sleep and nighttime awakenings in patients undergoing elective primary total hip and knee arthroplasty. The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. The higher the ESS score, the higher that person's average sleep propensity in daily life (ASP), or their 'daytime sleepiness'.
次要结局
- Change in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Score(Visit 1 (Screening Visit), 14 days after surgery visit)