A Prospective Cohort Study Exploring the Associations Between Chronic Postsurgical Pain and Postoperative Cognitive Dysfunction After Elective Knee or Hip Arthroplasty
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of postoperative cognitive dysfunction (binary outcome)
研究概览
简要总结
"Brain damage" and "memory loss" are main concerns of people undergoing surgery. In fact, many older people undergoing different types of non-cardiac surgeries (including orthopedic surgeries) present a significant decline in their cognition (i.e. the way people use their brain to think, take action, make decision, and remember) 1 year after surgery. This is called postoperative cognitive dysfunction (POCD), and is significantly more frequent (as many as 30% of patients aged 65 or older) than what we would expect in non-surgical patients with similar age and comorbidities. Causes and mechanisms of POCD are poorly understood. Pain after surgery is also very frequent and can persist for a long time (i.e. persistent postsurgical pain, PPSP), requiring chronic medications including narcotics. Knee surgery is more often offered as a treatment in older patients with osteoarthritis, who often come to surgery after a long history of pain and impaired mobility, and who often experience PPSP. The investigators proposed to conduct a study in 200 people 55 years old or older (expected age range 55-85) who are undergoing their elective knee surgery, to evaluate the association between PPSP (and its treatment) and POCD. How cognition can interfere with resilience (coping strategies and expectations), which are also thought to influence the persistence of pain, satisfaction, and functional recovery after surgery, will also be explored. Patients will be enrolled before their surgery and followed over time, to collect data on their social and clinical characteristics, measure copying/expectations before and after surgery, and assess pain and pain medications, satisfaction and functional recovery, and cognitive performance. The study will also explore hypotheses of possible mechanisms underlying the association between PPSP and POCD, and will include interviews with a subset of the participants to explore lived experiences of pain, mobility and aging, including resilience, expectations and satisfaction with surgery.
详细描述
The specific study objectives are to: 1- explore the association of CPSP, pain management (opioid use), and patient satisfaction, with postoperative cognitive dysfunction (POCD), measured both as change in the Montreal Cognitive Assessment (MoCA), and through a neuropsychological test battery, 2- explore whether postoperative cognitive changes are associated with changes in neurogenesis correlates and in neurotrophic factors levels, and whether this association is mediated by changes in pain, mobility, and satisfaction, and 3- explore the association between coping strategies/expectations as measured by the Somatic Preoccupation and Coping (SPOC) questionnaire and cognitive function, and in particular the relationship between changes in SPOC and cognitive changes from preoperative to 4-6 weeks after surgery.
Investigators will recruit 150 patients, 50 years or older scheduled for knee or hip arthroplasty 1-2 weeks before surgery (baseline) and collect information about their socio-demographics data, comorbidities, frailty, anxiety, pain, and pain medications. The SPOC questionnaire is administered at baseline and repeated at 4-6 weeks after surgery. CPSP (presence and severity) and satisfaction with surgery are measured at 3, 6, and 12 months. Cognitive / neuropsychological assessments will be administered at baseline, and 4-6 weeks, 6 months, and 12 months after surgery. Blood samples for serum and RNA expression analysis of biomarkers will be longitudinally collected with the same timeline.
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
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged 50 years or older,
- •scheduled for elective TKA or THA for osteoarthritis
- •able to provide informed consent.
排除标准
- •known history of dementia,
- •unavailability of tablet or computer with an internet connection for remote assessment,
- •patient unable to interact with a tablet or computer due to language, visual, or hearing impairment, or any severely limited mobility of the upper limb joints, OR
- •patient unable to understand spoken or written English.
结局指标
主要结局
Incidence of postoperative cognitive dysfunction (binary outcome)
时间窗: 6 and 12 months postoperative
defined as a \>=2 point decline in MoCA scores.
次要结局
- Changes in the Stroop color word color interference task CWIT(4-6 weeks and 6 and 12 months)
- Changes in the N-back test(4-6 weeks and 6 and 12 months)
- Changes in the Rapid serial Visual Presentation (RVP) test(4-6 weeks and 6 and 12 months)
- Changes in the Mnemonic Similarity Test scores(4-6 weeks and 6 and 12 months)
- Changes in the Visual Paired Associates Learning (PAL) test(4-6 weeks and 6 and 12 months)
研究者
Maura Marcucci
Assistant Professor, Department of Health Research Methods, Evidence and Impact and Department of Medicine
McMaster University