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临床试验/NCT04625231
NCT04625231已完成不适用

Shared Decision-Making Tool for Opioid Prescribing After Ambulatory Orthopedic Surgery in Veterans - A Randomized Controlled Clinical Trial

University of Colorado, Denver2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2018年11月9日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Number of Opioid Pills Dispensed

研究概览

简要总结

The purpose of this study is to determine if an educational patient-centered presentation reduced the amount of opioid pills requested and utilized by patients compared to standard of care 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
Triple (Participant, Care Provider, Investigator)

盲法说明

Both patients and investigators were blinded to group assignment until an envelope was opened after the patient consented.

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • a. 18-89 years of age
  • b. Patient at the Orthopedic Department at the Veterans Health Administration
  • c. Indicated for upper extremity surgeries: E.g., Carpal Tunnel Release, Trigger Finger Release, Cubital Tunnel Release, Ganglion Cyst Excision

排除标准

  • a. History of opioid use disorder
  • b. Had any recent surgery within four weeks of upper extremity procedure
  • c. Taking opioids prior to surgery
  • d. Returning to an institutionalized setting
  • e. Pregnancy
  • f. Unable to communicate in the English language
  • g. Allergy to any medication recommended for post-operative analgesia

结局指标

主要结局

Number of Opioid Pills Dispensed

时间窗: 1 day (Once after surgery)

Number of Opioid Pills Consumed

时间窗: 4 weeks

次要结局

  • Patient-Reported Outcomes Measurement Information System Pain Interference Score(Once a week for 4 weeks after surgery)
  • Patient-Reported Outcomes Measurement Information System Pain Intensity Score(Once a week for 4 weeks after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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