跳至主要内容
临床试验/NCT04247646
NCT04247646进行中(未招募)不适用

SLeep and OPioid UsE in Patients Undergoing Total Knee Arthroplasty

Scripps Health2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2020年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
120
试验地点
2
主要终点
Opioid use

研究概览

简要总结

Prescription opioid misuse and its associated negative effects have become an epidemic in the United States, and post-operative opioid use contributes to this terrible problem. Alternative strategies to opioid prescribing are thus highly sought after in the post-operative setting. Importantly, sleep and pain have a bi-directional relationship, and inadequate or impaired sleep regularly occur following orthopedic operations. Melatonin is an endogenous sleep hormone that can be administered exogenously, and that has been shown to have some potential as an analgesic agent. Here, using the premise that melatonin may improve sleep and pain in the post-operative setting, the investigators propose a randomized clinical trial in 120 participants undergoing total knee arthroplasties. Patients will be randomized to receive either sublingual melatonin 5 mg or matched placebo starting on post-operative day (POD) 0 and through POD . The investigators will measure post-operative opioid usage as the primary outcome, and post-operative pain scores as a secondary outcome. The primary safety outcome will be sedation level, as measured by the Richmond Agitation Sedation Scale (RASS). Sleep will be measured objectively using wrist-worn actigraphy. Participants will be followed through POD 28, and will also have baseline data on sleep, pain, and cognition obtained prior to surgery.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults age 18 years and older
  • Undergoing elective total knee arthroplasty (single knee)

排除标准

  • Non-English speakers
  • Individuals with dementia
  • Patients with liver cirrhosis
  • Patients currently taking prescription sleep aids
  • Patients with long-term (greater than 3 months prior to surgery), chronic opioid use

结局指标

主要结局

Opioid use

时间窗: Post-operative day 0 through post-operative day 28

morphine milligram equivalents of opioid medications used by the participant

次要结局

  • Pain level(Post-operative day 0 through post-operative day 28)
  • Sleep fragmentation(Post-operative day 0 through post-operative day 28)
  • Total daily sleep duration(Post-operative day 0 through post-operative day 28)
  • Nightly sleep duration(Post-operative day 0 through post-operative day 28)
  • Other pain medicine usage(Post-operative day 0 through post-operative day 28)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stuti Jaiswal

Faculty Hospitalist

Scripps Health

研究点 (2)

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