Personalized Post-Operative Opiate Prescriptions Based on Pharmacogenetics of CytochromeP450, COMT, and OPRM1
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- Persistent Post-Operative Opioid Use
研究概览
简要总结
The main questions this study aims to answer are:
Does perioperative PGx personalized opiate therapy reduce persistent post-operative opioid use dependency, improve pain management and reduce opiate related adverse events in opioid naïve patients after surgery?
Participants will:
Take hydromorphone if the PGx results determine they have a SNP indicating high or low metabolic activity in the CYP2D6 enzyme.
Complete a 7-day pain diary post-discharge. Complete a follow-up phone call once per month for 90 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1.18-85 years of age 2.Able to read and understand study procedures. 3.Willing to participate and sign an ICF. 4.Opioid naïve 90 days prior to surgery.
排除标准
- •<18 years of age and >85 years of age
- •Unable to understand study procedures.
- •Unwilling to give consent.
- •Patients with cognitive impairment that can affect their ability to give consent.
- •Previous Surgery <14 days from time of enrollment.
- •Allergies to study intervention or oxycodone.
研究组 & 干预措施
Standard post-operative pain management (control)
Patients in the control groups will follow the current hospital standard of care and receive oxycodone 5mg every 4 hours as needed for moderate pain and oxycodone 10mg every four hours as needed for severe pain.
干预措施: PGx guided personalized post-operative pain management (Other)
Standard post-operative pain management (control)
Patients in the control groups will follow the current hospital standard of care and receive oxycodone 5mg every 4 hours as needed for moderate pain and oxycodone 10mg every four hours as needed for severe pain.
干预措施: Oxycodone (Drug)
Pharmacogenomics (PGx) guided treatment (hydromorphone)
Patients who are poor CYP2D6 metabolizers or rapid CYP2D6 metabolizers with moderate or severe pain, will be prescribed either oral hydromorphone 2mg every 4 hours as needed or oral hydromorphone 4mg every 4 hours as needed, respectively.
干预措施: PGx guided personalized post-operative pain management (Other)
Pharmacogenomics (PGx) guided treatment (hydromorphone)
Patients who are poor CYP2D6 metabolizers or rapid CYP2D6 metabolizers with moderate or severe pain, will be prescribed either oral hydromorphone 2mg every 4 hours as needed or oral hydromorphone 4mg every 4 hours as needed, respectively.
干预措施: Hydromorphone (Drug)
结局指标
主要结局
Persistent Post-Operative Opioid Use
时间窗: 90 days
To determine the overall difference in the number of post-operative opioid prescriptions in 90 days using PGx guided post operative medication
次要结局
- Post-Surgical Pain(7 days)
研究者
Trey Henderson
Study Coordinator
University of Tennessee Graduate School of Medicine