How Variations in Patient Pharmacogenomic Profiles Affect Pain and Narcotic Requirements Following Total Knee Arthroplasty (TKA)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 375
- 试验地点
- 1
- 主要终点
- Determine how variation in a pharmacogenomics panel affects a patient's perception of pain.
研究概览
简要总结
The purpose of the study is to gain a better understanding of how genetic variations can affect pain experience and the need and type of pain control medication after a total knee replacement.
详细描述
The purpose of the study is to gain a better understanding of how genetic variations can affect pain experience and the need and type of pain control medication after a total knee replacement. People experience pain differently. The type and amount of medication required to control pain varies. Post-operative pain often requires narcotics to keep patients comfortable. It has been shown that there is a genetic difference in how people respond to pain and how they respond to the medications used for the relief of pain. Opioids are often used to relieve pain after surgery. These medications can be abused and have had a role in the current opioid crisis.
Pharmacogenomics is the study of how patients respond to and metabolize drugs and medications based on their genetic profiles. This study will collect data on the pain experienced by participants and the narcotics used after total knee replacements. This will be correlated with the participants' pharmacogenomic profiles obtained though DNA testing. There are no treatment interventions in this study. Although a pharmacogenomic profile will be obtained at the first post-operative visit and reported approximately 3 weeks later, the subject will have completed the need for pain relief. The study is expected to last 2 years with 300 subjects enrolled.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 or older
- •Unilateral primary Total Knee Arthroscopy (TKA)
- •Knee Osteoarthritis
- •Planned discharge to home
排除标准
- •Unicompartmental Total Knee Arthroscopy (TKA)
- •Revision Total Knee Arthroscopy (TKA)
- •Knee flexion contracture > 15°
- •Axial deformity > 15°
- •Previous or current chronic narcotic use for pain > 3 months
- •Previous or current substance abuse
- •Any chronic pain condition
- •Any dementia or cognitive disorder
- •Discharge to Skilled Nursing Facility
- •Rheumatoid arthritis
- •Potential difficulty completing daily pain scores and medication use
- •Previous NorthShore genotyping
- •Currently taking CYP2D6 inhibitors (list in appendix)
- •Currently taking CYP2D6 inducers (list in appendix)
结局指标
主要结局
Determine how variation in a pharmacogenomics panel affects a patient's perception of pain.
时间窗: 30 days
The variation in genetics will be investigated using a standard 20 gene clinical pharmacogenomics panel. Three of these genes (CYP2D6, OPRM1, and COMT) have effects on opioid metabolism, opioid transport, pain perception, and opioid receptors. The results of the pharmacogenomics panel in relation to pain as assessed by the VAS (Visual Analog Scale) numeric pain scale completed by each subject for maximum pain experienced with activity, average pain, and lowest level of pain over the previous 24 hours. The VAS is a self-reported score which measures pain on a 0-10 scale with 10 being the most amount of pain possible and 0 being no pain.
Determine how variation in a pharmacogenomics panel affects the amount of opioids needed to control a patient's pain.
时间窗: 30 days
The results of the pharmacogenomics panel in relation to the amount of opioids needed to control post-operative pain for the first month following surgery will be assessed via a daily medication log completed by patients where they record the specific medication and dose taken in the previous 24 hour period each day of the month following surgery. This will be converted to morphine milligram equivalents (MME) and expressed as the total MME used in the first post-operative month.
次要结局
- Secondary outcome will be measuring changes in the VR-12 (Veterans Rand Item Health Survey).(1 year)
- Secondary outcome will be measuring changes in the PROMIS-43.(1 year)
- Secondary outcome will be measuring changes in ROM (range of motion) as determined by the physician.(1 year)
- A secondary outcome will be measuring changes in the KOOS Jr (Knee injury and Osteoarthritis Outcome Score- Junior).(1 year)
研究者
Richard Wixson
Physician, FPA
NorthShore University HealthSystem