Genomic Opioid Optimization of Dosing and Selections (GOODS) Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Change in Overall Benefit of Analgesic Score (OBAS)
研究概览
简要总结
The researchers are conducting this study to see if pharmacogenomic testing before surgery helps the doctor to choose which medications will work best for the patient.
详细描述
Participants, undergoing total knee replacements, will be randomized into two groups. Both groups will receive pharmacogenomics (PGx) testing preoperatively. The PGx guided group will have their results reviewed by the clinicians during their treatment and the results may guide clinical decisions. The control group results will be sealed until completion of treatment and clinicians will not have access to this information. These participants will undergo standard treatment dosing and medication selection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Participant)
盲法说明
Participants will not be aware of which arm of the study they are enrolled.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing primary total knee arthroplasty
- •Patients must understand and provide written informed consent and HIPAA authorization prior to initiation of any study-specific procedures.
排除标准
- •Patients with a current diagnosis of chronic pain
- •Patients requiring narcotics for greater than one week prior to surgery
- •Patients with chronic kidney disease with a pre-op creatinine greater than 1.5
- •Patient preference or need for spinal anesthesia rather than general anesthesia
- •Patient planned for robotic surgical approach
结局指标
主要结局
Change in Overall Benefit of Analgesic Score (OBAS)
时间窗: baseline, 48 hours following PACU discharge
The overall benefit of analgesia score (OBAS) is a daily multi-dimensional survey that assesses analgesia benefits, opioid-related adverse events (ORAEs), and patient satisfaction. It is a seven-item scale, with items ranging from( 0 = not at all) to(4 = very much). To calculate the Total OBAS score, compute the sum of scores in items 1-6 and add '4-score in item 7'. Low score indicates high benefit.
次要结局
- Change in prescription pattern for postoperative pain control.(baseline, 48 hours following PACU discharge)
- Change in Opioid requirements(baseline, 48 hours following PACU discharge)
- Changes in opioid use perioperatively based on pharmacogenomic testing(baseline, 48 hours following PACU discharge)
研究者
Molly B. Kraus
Assistant Professor of Anesthesiology
Mayo Clinic