Association Between Melatonin Use and Improved Sleep Quality After Total Knee Arthroplasty: A Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 176
- 试验地点
- 1
- 主要终点
- Sleep Quality
研究概览
简要总结
This randomized controlled trial (RCT) will compare the effects of melatonin vs. placebo in patients undergoing primary total knee arthroplasty (TKA). This RCT aims to study the effects melatonin has on sleep quality after TKA. Patients will be blinded to their respective groups and will be instructed to take either 5mg melatonin or a placebo pill (Vitamin C) for 6 weeks postoperative. Sleep quality surveys will be administered preoperatively and post-operative week 6, 90-days and 1 year. Poor sleep quality is a common issue faced by patients undergoing TKA. The goal of this study is see if melatonin can improve postoperative sleep quality, and if so, does improved sleep quality correlate to improvements in other postoperative outcomes.
详细描述
This study will compare postoperative sleep quality in two groups of patients undergoing primary total knee arthroplasty (TKA):
- Group 1 will take one melatonin (5 mg) tablet nightly, ~30 minutes before bedtime during the 6 week postoperative period
- Group 2 will take one placebo (5 mg Vitamin C) tablet nightly, ~30 minutes before bedtime during the 6 week postoperative period
The primary outcome will be sleep quality at 6 weeks. Sleep quality will be measured using the Pittsburgh Sleep Quality Index (PSQI). The survey will be administered preoperatively, 6-weeks, 90-days and 1 year postoperatively. Preoperative surveys will be completed in-person, on-site by study participants. All postoperative surveys will be distributed via email.
Secondary outcomes include:
- (KOOS Jr, LEAS, VR-12, VAS) administered preoperatively, at 6-weeks, 90-days and 1-year post-operatively.
- Total opioids prescribed in first 3 months postoperative will be collected using iStop
- Frequency of CMS defined surgicalcomplications in the first 90-days after primary TKA.
- Adverse events of Melatonin during the first 6 weeks (collected via email survey sent to participants once per week, for the first 6 weeks)
- Study medication compliance at 6 weeks (collected via email survey sent to participants once per week, for the first 6 weeks)
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
- Single (Participant)
盲法说明
Participants will not be informed if they are receiving study drugs or placebo pills.
Placebos will be compounded to be identical to treatment drugs in shape, size, color, texture etc.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients undergoing primary, unilateral TKA
- •Primary diagnosis of osteoarthritis (OA)
- •Subject is opioid naive (has not taken opioids during the 6 months prior to surgery)
- •Subject is not currently taking sleep medication
- •English speaking
- •Has working email (for survey purposes)
排除标准
- •Patients with diagnosis other than OA including: Inflammatory arthritis; Post-traumatic OA; Chronic pain; Insomnia*; Depression*; Anxiety*; Any active sleep disorder
- •Planned contralateral knee or subsequent total joint arthroplasty within 90 days
- •Any planned surgery within 90 days
- •Patient taking medication for depression or insomnia or anxiety during the 6 months prior to surgery
- •Patients with renal or hepatic disorders as these can affect melatonin metabolism
- •Insomnia, anxiety, and depression will be defined as use of controlled medication for that disorder which will be identified in istop or HSS record of the patient filled in the 6 months prior to surgery
结局指标
主要结局
Sleep Quality
时间窗: 1-year
Assessed based on self-reported data collected using the Pittsburgh Sleep Quality Index (PSQI). Minimum Score: 0; Maximum Score: 21. Higher scores indicate a worse outcome.
次要结局
- Overall Health(Preoperatively, 6-week, 90-day and 1-year follow-up)
- Knee Function(Preoperatively, 6-week, 90-day and 1-year follow-up)
- Lower Extremity Activity(Preoperatively, 6-week, 90-day and 1-year follow-up)
- Pain Ratings(Preoperatively, 6-week, 90-day and 1-year follow-up)
- Opioids Prescribed(90-day follow-up)
- Study Medication Compliance(Weekly (Up to 6 weeks))
- Quantity of Postoperative Centers for Medicare and Medicaid Services Complications(90-day follow-up)
- Quantity of Adverse Melatonin Medical Events(Weekly (Up to 6 weeks))