Clinical trial NCT05614271: Chronic Postsurgical Pain, Postoperative Cognitive Dysfunction and Resilience
Official title: A Prospective Cohort Study Exploring the Associations Between Chronic Postsurgical Pain and Postoperative Cognitive Dysfunction After Elective Knee or Hip Arthroplasty
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postoperative Cognitive Dysfunction
Chronic Post Operative Pain
Satisfaction, Patient
Coping Behavior
Keywords: Older adults
Total knee arthroplasty
Total hip arthroplasty
Postoperative cognitive dysfunction
chronic postsurgical pain
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: The McMaster Institute for Research on Aging (MIRA)
name: Michael G. DeGroote Institute for Pain Research and Care (IPRC)
First posted: 2022-11-14
Enrollment: 100
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients 50 years or older undergoing elective total knee arthroplasty (TKA) or total hip arthroplasty (THA) for osteoarthritis

Brief summary: "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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. aged 50 years or older,
2. scheduled for elective TKA or THA for osteoarthritis
3. able to provide informed consent.

Exclusion Criteria:

1. known history of dementia,
2. unavailability of tablet or computer with an internet connection for remote assessment,
3. 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
4. patient unable to understand spoken or written English.

Primary outcomes:
measure: Incidence of postoperative cognitive dysfunction (binary outcome)
timeFrame: 6 and 12 months postoperative
Secondary outcomes:
measure: Changes in the Mnemonic Similarity Test scores
timeFrame: 4-6 weeks and 6 and 12 months
measure: Changes in the Visual Paired Associates Learning (PAL) test
timeFrame: 4-6 weeks and 6 and 12 months
measure: Changes in the Rapid serial Visual Presentation (RVP) test
timeFrame: 4-6 weeks and 6 and 12 months
measure: Changes in the Stroop color word color interference task CWIT
timeFrame: 4-6 weeks and 6 and 12 months
measure: Changes in the N-back test
timeFrame: 4-6 weeks and 6 and 12 months
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: McMaster University
state: Ontario
Study officials:
affiliation: McMaster University
name: Maura Marcucci, MD
role: PRINCIPAL_INVESTIGATOR
References: