Randomized Trial on Expectations and Pain Control Advancement In surgeRy: The REPAIR Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 174
- 试验地点
- 2
- 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
- 否
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)
研究组 & 干预措施
Patient Centered pre-op education
Patient centered pre-operative education and patient centered post-operative care.
干预措施: Patient centered pre-op education (Behavioral)
Routine Pre-op education
Participants will receive routine pre-operative education and post-op will receive a standardized number of narcotics
干预措施: routine preop education (Behavioral)
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
Peter C Jeppson
Principal Investigator, Assistant Professor
University of New Mexico
