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临床试验/NCT03726476
NCT03726476已完成不适用

Randomized Trial on Expectations and Pain Control Advancement In surgeRy: The REPAIR Trial

University of New Mexico4 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2019年9月10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
174
试验地点
4
主要终点
Opioid Use at Approximately Two Weeks Post-op

研究概览

简要总结

This is a randomized control trial that aims to evaluate whether patient-centered education, compared to routine education, decreases narcotic consumption without interfering with return to physical activity following hospital discharge. In addition, it will test whether patient-centered education decreases the quantity of narcotics prescribed and/or increases patient satisfaction and preparedness.

详细描述

Opioid use disorder is a national health emergency. Opioid prescribing practices to treat post-operative pain have contributed to the problem. This study seeks to explore the effects of changing pre-operative education & increasing patient input regarding post-operative receipt of opioids. The study will explore the effects that change in pre-operative education may have on post-operative opioid consumption juxtaposed upon return to physical activity using a randomized trial design. Women undergoing pelvic floor reconstructive surgery will be randomized to either (i) standard pre-operative education (ii) modified, patient-centered pre-operative education. The investigators will monitor both post-operative opioid consumption and return to physical activity. The investigators hypothesize that investigation of patient's post-operative pain experiences and their inclusion in the educational and the shared decision-making process will likely decrease post-operative narcotic use without affecting return to function. Our long-term goal is to develop a pragmatic and balanced approach to address pain concerns, decreasing the medical community's contribution to the opioid epidemic.

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
Single (Investigator)

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

  • Subjects are ≥ 18 years of age
  • English or Spanish speaking
  • Patient scheduled for pelvic floor surgery

排除标准

  • Unable to speak English or Spanish
  • Using long acting opioids (e.g. MS Contin, Fentanyl patch)
  • Primary or Pain Healthcare Provider recommends against study participation (eg. If the patient has a history of opioid use disorder or other confounding problems, we will contact the Primary Care Provider or Pain Healthcare Provider for their recommendations regarding study participation)

结局指标

主要结局

Opioid Use at Approximately Two Weeks Post-op

时间窗: 2 weeks

Morphine milligram equivalents at the two weeks post-op

次要结局

  • Opioid Use at Approximately Six to Eight Weeks Post-op(6-8 weeks)

研究者

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

Peter C Jeppson

Principal Investigator, Assistant Professor

University of New Mexico

研究点 (4)

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