跳至主要内容
临床试验/NCT03269760
NCT03269760已完成1 期

Advancing the Multimodal Pathway: Investigating the Use of Sleep and Zolpidem in the Recovery After Shoulder Arthroplasty

University of California, San Francisco1 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2017年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
122
试验地点
1
主要终点
Lead's Sleep scale

研究概览

简要总结

The purpose of the study is to investigate the efficacy of sleep medicine in the recovery of orthopaedic shoulder arthroplasty patients. The investigators hypothesize that a multimodal sleep pathway including non-pharmacological sleep hygiene interventions and the use of zolpidem can improve patient sleep, pain control, and subsequent recovery after undergoing total shoulder arthroplasty.

详细描述

Shoulder pain at night is a common symptom of shoulder arthritis and contributes to sleep disturbances. Many patients also have difficulty sleeping after shoulder surgery due to the constraints of sling immobilization. While in the hospital, sleep is also disrupted due to pain, nursing staff, other patients, and bathroom use. While poor sleep may appear trivial, sleep deprivation in animal models has identified significant adverse effects on bone metabolism, bone mass, and recovery from post surgical pain.

Recent evidence has shown that non-pharmacological sleep interventions that improve sleep hygiene and duration can optimize athletic peak performance, fatigue, and recovery. Furthermore, pharmacological sleep aid use with zolpidem in orthopaedic postoperative patients has suggested safe administration, improved pain control, reduced pain medication use, and higher patient satisfaction in the settings of total knee and hip arthroplasty, rotator cuff repairs, and ACL reconstruction.

The purpose of the study is to investigate the efficacy of sleep medicine in the recovery of orthopaedic shoulder arthroplasty patients. The investigators hypothesize that a multimodal sleep pathway including non-pharmacological sleep hygiene interventions and the use of zolpidem can improve patient sleep, pain control, and subsequent recovery after undergoing total shoulder arthroplasty.

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
None

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

  • All consenting adults undergoing elective total shoulder replacement

排除标准

  • Allergies to zolpidem or refusal to participate in study

研究组 & 干预措施

Interventional Sleep Medicine

Experimental

Use of a multimodal sleep pathway including non-pharmacological sleep hygiene interventions and the use of zolpidem to improve patient sleep, pain control, and subsequent recovery after undergoing total shoulder arthroplasty.

干预措施: Zolpidem (Drug)

结局指标

主要结局

Lead's Sleep scale

时间窗: postoperative day 1

Patient reported outcome

次要结局

  • Sleep journals(postoperative day 1-7)
  • Pain scores(postoperative day 1)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验