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临床试验/NCT02770612
NCT02770612已完成不适用

Shared Decision Making for Prescription Opioids After Cesarean Delivery

Massachusetts General Hospital2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2016年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
2
主要终点
Pain Management and Opioid Usage Measured by Telephone Questionnaire

研究概览

简要总结

The specific aim of this study is to use a shared decision making tool to allow women who have undergone cesarean delivery (CD) to choose the amount of oxycodone the participants will be prescribed at discharge, within a range from 0-40 tablets. The study investigators will document additional information from medical record abstraction (age, race/ethnicity, medical and obstetrical conditions, previous opioid use, date of CD, indication for CD, anesthetic management during CD, duration and complications of CD, length of stay, pain medication use and pain scores on each postoperative day between CD and discharge). The investigators will then follow up with the participants by telephone at two weeks after discharge to assess the amount of opioid used, frequency of prescription refill, disposition of unused medication, and participant satisfaction with their post-cesarean pain control. The investigators hypothesize that the use of a shared decision making tool will decrease the amount of opioid prescribed while still providing participants with satisfactory pain control.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • Postpartum women who underwent a cesarean delivery at MGH

排除标准

  • Non-native English speakers (identified in LMR as "non-English speaking" or "requires interpreter")
  • Women with a history of chronic opioid abuse (identified in LMR as "opioid abuse" or "narcotic abuse")
  • Chronic pain on opioids (identified in LMR as "chronic pain" or "chronic narcotic use")
  • Women on methadone or buprenorphine for treatment of opioid addiction (identified from their medication list in the LMR)
  • Women with impaired decision-making abilities
  • Women hospitalized for > 7 days related to CD
  • Minors (<18 years old)
  • Women being prescribed an opioid other than oxycodone during their postpartum hospitalization (identified from the MAR and discussion with rounding providers)
  • Women with contraindications to taking acetaminophen or NSAIDs

结局指标

主要结局

Pain Management and Opioid Usage Measured by Telephone Questionnaire

时间窗: Within 2 weeks postpartum

Outpatient opioid selection and use after discharge

次要结局

未报告次要终点

研究者

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

Brian Bateman

MD, MSc

Massachusetts General Hospital

研究点 (2)

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