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临床试验/NCT03808025
NCT03808025已完成不适用

Opioid Use in Shoulder Arthroplasty Patients: A Stratification and Algorithm

University of California, Davis1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2019年1月21日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
1
主要终点
Opioid use

研究概览

简要总结

The investigators aim to better understand opioid use in patients undergoing elective shoulder surgery. The investigators will prospectively determine actual postoperative opioid use, while evaluating whether implementation of an educational session with pain contract would help minimize opioid use.

详细描述

The investigators aim to better understand opioid use in patients undergoing elective shoulder surgery. As part of a multi-part investigation, The investigators intend to prospectively determine actual postoperative opioid use, while evaluating whether implementation of an educational session with pain contract would help minimize opioid use. Through use of a teaching session and pain contract, it is hypothesized opioid use would decrease. The investigators hypothesize the use of a pain contract and thorough discussion regarding proper opioid use and side-effects, will decrease the amount of postoperative opioid use.

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 (Outcomes Assessor)

盲法说明

Patients who consent to the study will be prospectively randomized to one of two arms: one will receive educational intervention, the other will not. Investigators will be masked to patient intervention when assessing and collecting outcomes.

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

  • •18 years or older with capacity to consent
  • •presenting to UC Davis Medical Center Department of Orthopedic Surgery and planning to undergo elective shoulder surgery

排除标准

  • •unable to consent
  • •prisoners
  • •pregnant women

研究组 & 干预措施

education

Experimental

The teaching arm would consist of a standardized dialogue the surgeon will complete with the patient in order to familiarize the patient with the risks of over-prescribing opioid medication and set patient expectations regarding the clinic's opioid prescribing pattern protocol, in an effort to minimize the number of opioid pills prescribed or refills required, the amount actually used, and the untoward side effects of opioid use (e.g. respiratory depression, nausea, sedation, restriction from driving, and access to and use by those the medication was not intended).

干预措施: opioid education (Behavioral)

no education

No Intervention

Standard preoperative care without dedicated teaching regarding opioid use and risks

结局指标

主要结局

Opioid use

时间窗: 6 months after surgery

Total opioid use

次要结局

  • Number of refills(6 months after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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