Ignite Creation Date:
2024-05-06 @ 6:18 PM
Last Modification Date:
2024-10-26 @ 2:45 PM
Study NCT ID:
NCT05614271
Status:
RECRUITING
Last Update Posted:
2022-11-14
First Post:
2022-10-28
Brief Title:
Chronic Postsurgical Pain Postoperative Cognitive Dysfunction and Resilience
Sponsor:
McMaster University
Organization:
McMaster University
Study Overview
Official Title:
A Prospective Cohort Study Exploring the Associations Between Chronic Postsurgical Pain and Postoperative Cognitive Dysfunction After Elective Knee or Hip Arthroplasty
Status:
RECRUITING
Status Verified Date:
2022-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ArthroCaP
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 ie 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 ie 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 copyingexpectations 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 strategiesexpectations 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None