Feasibility and Efficacy of CYP2D6 Genotype-guided Management of Opioid Analgesics in Patients Undergoing Elective Ventral Hernia Repairs: A Pilot Pragmatic Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Determine the feasibility of a CYP2D6-guided opioid prescribing by the percentage enrolled of patients undergoing elective VHRs compared to usual care.
研究概览
简要总结
Pilot pragmatic trial using an implementation science approach to determine the feasibility of a CYP2D6-guided opioid prescribing for patients undergoing elective VHRs compared to usual care. Assess the efficacy (PROMIS Pain Intensity and Hernia-Related QOL) of a CYP2D6-guided opioid prescribing approach for patients undergoing elective VHRs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •> 18 years age undergoing a ventral hernia repair (VHR) ≥1.5 cm in diameter with mesh.
排除标准
- •ventral hernia <1.5 cm
- •primary ventral hernia repair (VHR) without a mesh
- •emergency operative procedure
- •receiving chronic opioid therapy (defined as use of opioids on most days for >3 months)
- •allergy to opioids
- •women of childbearing potential who have a positive pregnancy result as part of their standard pre-surgical workup
研究组 & 干预措施
CYP2D6 genotype testing-control
CYP2D6 genotype testing performed preoperatively, results will be delayed until after operative procedure. Participants will receive standard of care postoperative pain medication prescriptions for pain management.
干预措施: Acetaminophen and Gabapentin: standard postoperative pain medications (Other)
CYP2D6 genotype testing-treatment
CYP2D6 genotype testing performed preoperatively with results used to guide prescribing of opioid analgesics during the postoperative period to control pain. In addition, participants will receive standard of care postoperative pain medications.
干预措施: Opioid pain medication prescribed based on CYP2D6 genotype testing PLUS Acetaminophen and Gabapentin (Other)
结局指标
主要结局
Determine the feasibility of a CYP2D6-guided opioid prescribing by the percentage enrolled of patients undergoing elective VHRs compared to usual care.
时间窗: 6 months
Percentage of potential participants approached will enroll and complete study.
次要结局
- Assess the efficacy of a CYP2D6-guided opioid prescribing approach for patients undergoing elective VHRs.(6 months)