Chronic Postsurgical Pain, Postoperative Cognitive Dysfunction and Resilience

NCT05614271 | Unknown

• 1 other identifier: 13598
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Incidence of postoperative cognitive dysfunction (binary outcome)

  defined as a \>=2 point decline in MoCA scores.

  6 and 12 months postoperative

Secondary Outcomes (5)

• 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

• Changes in the Rapid serial Visual Presentation (RVP) test

  4-6 weeks and 6 and 12 months

• 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

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• McMaster University: lead
• The McMaster Institute for Research on Aging (MIRA): collaborator
• Michael G. DeGroote Institute for Pain Research and Care (IPRC): collaborator

Study Sites (1)

McMaster University

Hamilton, Ontario, L8S 4L8, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood

MeSH Terms

Conditions

Postoperative Cognitive Complications; Pain, Postoperative; Patient Satisfaction

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Pain; Neurologic Manifestations; Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Maura Marcucci, MD

  McMaster University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maura Marcucci, MD

CONTACT

9055274322; marcum2@mcmaster.ca

Maram Khaled, MBBCh, MSc

CONTACT

9059220293; khalem3@mcmaster.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Health Research Methods, Evidence and Impact and Department of Medicine

Study Record Dates

• First Submitted: October 28, 2022
• First Posted: November 14, 2022
• Study Start: October 1, 2021
• Primary Completion: April 30, 2023
• Study Completion: July 31, 2024
• Last Updated: November 14, 2022

Record last verified: 2022-11

Locations

CA (1)