NCT04278677Unknown不适用
Sleep Quality and Pain Medication Use Following Arthroscopic Rotator Cuff Repair
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Pittsburg Sleep Quality Index (PSQI)
研究概览
简要总结
The purpose of this study is to investigate if oral melatonin reduces postoperative sleep 18 disturbances and narcotics use. We will enroll patients undergoing primary arthroscopic rotator 19 cuff repair (ARCR) at the Rothman Institute.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
This is a provider-crossover study design: subjects will receive treatment according to their provider's standard of care
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 who undergo primary ARCR
- •Patient willing and able to complete postoperative surveys
排除标准
- •Daily melatonin use for > 1 week during the last 3 months
- •Irreparable tears
- •Revision rotator cuff repairs
- •Severe glenohumeral arthritis
- •Concurrent adhesive capsulitis
- •Age less than 18
- •Pregnancy
- •History of substance abuse (drug or alcohol)
- •Workman's comp patient or patient has current litigation pending
- •Allergy to melatonin
- •History of delirium/psychiatric/depression/ on antidepressants
- •History of insomnia/ on sleep aid medication
- •Use of prescription sedatives
- •use of Zelboraf (vemurafenib)
- •Use of all blood thinning medications besides aspirin (warfarin, plavix, lovenox, etc.)
- •Sleep apnea
结局指标
主要结局
Pittsburg Sleep Quality Index (PSQI)
时间窗: 6 weeks post-surgery
PSQI is a validated outcome measure for sleep quality
次要结局
未报告次要终点
研究者
研究点 (2)
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