Ignite Creation Date:
2024-05-06 @ 6:00 PM
Last Modification Date:
2024-10-26 @ 2:39 PM
Study NCT ID:
NCT05510947
Status:
COMPLETED
Last Update Posted:
2024-02-07
First Post:
2022-08-17
Brief Title:
Acute Postoperative Pain and Catastrophizing in Patients Undergoing Unicompartmental Knee Arthroplasty
Sponsor:
Copenhagen University Hospital Hvidovre
Organization:
Copenhagen University Hospital Hvidovre
Study Overview
Official Title:
Acute Postoperative Pain and Catastrophizing in Patients Undergoing Unicompartmental Knee Arthroplasty - A Prospective Observational Single-center Cohort Study
Status:
COMPLETED
Status Verified Date:
2024-02
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:
KATUKA
Brief Summary:
Advantages of unicompartmental knee arthroplasty UKA compared to total knee arthroplasty TKA include shorter hospital stays faster recovery fewer infections and readmission and lower costs It is well documented in TKA-surgery that high pain responders HPR evaluated using the Pain Catastrophizing Scale PCS have higher postoperative pain responses compared to low pain responders LPR These HPR-patients constitute a vulnerable high risk patient group and potentially benefit from targeted treatment Currently the distribution of HPR- and LPR-patients and their association with acute pain following UKA is not well investigated The knowledge that this research project generates is essential to determine how studies with analgesia interventions should be designed In the future this will contribute in targeting treatment for high risk patient groups to reduce pain and improve postoperative mobilization and ultimately decrease length of hospital stay in patients undergoing UKA By targeting treatment a potential overtreatment is also avoided
The aim of this study is to investigate the prevalence of high- and low-pain responders defined by a PCS score 20 and 20 respectively as well as the acute postoperative course of pain for these groups after unicompartmental knee arthroplasty
The aim of this study is to investigate the prevalence of high- and low-pain responders defined by a PCS score 20 and 20 respectively as well as the acute postoperative course of pain for these groups after unicompartmental knee arthroplasty
Detailed Description:
Background
Primary knee arthroplasty is a frequently performed procedure and is expected to increase in numbers over the next decade Advantages of unicompartmental knee arthroplasty UKA compared to total knee arthroplasty TKA include shorter hospital stays faster recovery fewer infections and readmissions and lower costs The length of hospital stay after UKA is variable but an increased length of hospitalization has been associated with more complications and higher readmission rates A recent study has shown that the main reasons for continued hospitalization beyond 24 hours after surgery are pain and lack of mobilization Strategies to decrease the length of stay after UKA should thus be aimed at improved analgesia and postoperative mobilization
There is a large interindividual variability in the postoperative pain response It is well documented in TKA-surgery that high pain responders HPR evaluated using the Pain Catastrophizing Scale PCS have higher postoperative pain responses compared to low pain responders LPR Recently it has been shown that HPR patients undergoing TKA benefit from a larger preoperative dose of glucocorticoid compared to a previously recommended dose Interestingly the same difference has not been found in LPR patients Nielsen et al IN PREPARATION clinicaltrialsgov ID NCT03758170 EudraCT 2018-002634-20 VEK H-18034756 These HPR patients constitute a vulnerable high-risk patient group and potentially benefit from targeted treatment
Currently the distribution of HPR- and LPR patients and their association with acute pain following UKA is not well investigated The generated knowledge from this research project is essential to determine how studies with analgesia interventions should be designed In the future this will contribute to targeting treatment for high-risk patient groups to reduce pain and improve postoperative mobilization and ultimately decrease the length of hospital stay in patients undergoing UKA By targeting treatment a potential overtreatment is also avoided
Aim
To investigate the prevalence of high- and low-pain responders defined by a PCS score 20 and 20 respectively as well as the acute postoperative course of pain for these groups after unicompartmental knee arthroplasty
Study location
The inclusion will take place at the Dept of Orthopaedic Surgery Arthroplasty unit at Hvidovre Hospital Capital Region of Denmark
Study plan
In the outpatient clinic the screening procedure will be performed among patients planned to UKA by the surgeons Patients will be asked if they may be contacted with the purpose of participating in a research project Patients will undergo a preliminary examination where as a standard procedure the patient will receive a PCS questionnaire Patients will be informed of the research project either in the outpatient clinic or by phone from an investigator
All patients will receive verbal and written information about the project All patients must give a signed informed consent on paper prior to inclusion to participate in the study
Data protection
All patient-related information will be treated confidentially and data will be pseudoanonymized Signed informed consent from participating patients will be stored at the Anesthesiologic Dept 542 Hvidovre Hospital in a locked cabinet All electronic data will be stored in REDCap
Collected variables
During the hospital stay data will be collected by contacting the patient at the Orthopaedic Dept and by accessing the electronic patient journal After discharge patients will be asked to fill out an electronic pain diary until 7 days after the operation
Primary knee arthroplasty is a frequently performed procedure and is expected to increase in numbers over the next decade Advantages of unicompartmental knee arthroplasty UKA compared to total knee arthroplasty TKA include shorter hospital stays faster recovery fewer infections and readmissions and lower costs The length of hospital stay after UKA is variable but an increased length of hospitalization has been associated with more complications and higher readmission rates A recent study has shown that the main reasons for continued hospitalization beyond 24 hours after surgery are pain and lack of mobilization Strategies to decrease the length of stay after UKA should thus be aimed at improved analgesia and postoperative mobilization
There is a large interindividual variability in the postoperative pain response It is well documented in TKA-surgery that high pain responders HPR evaluated using the Pain Catastrophizing Scale PCS have higher postoperative pain responses compared to low pain responders LPR Recently it has been shown that HPR patients undergoing TKA benefit from a larger preoperative dose of glucocorticoid compared to a previously recommended dose Interestingly the same difference has not been found in LPR patients Nielsen et al IN PREPARATION clinicaltrialsgov ID NCT03758170 EudraCT 2018-002634-20 VEK H-18034756 These HPR patients constitute a vulnerable high-risk patient group and potentially benefit from targeted treatment
Currently the distribution of HPR- and LPR patients and their association with acute pain following UKA is not well investigated The generated knowledge from this research project is essential to determine how studies with analgesia interventions should be designed In the future this will contribute to targeting treatment for high-risk patient groups to reduce pain and improve postoperative mobilization and ultimately decrease the length of hospital stay in patients undergoing UKA By targeting treatment a potential overtreatment is also avoided
Aim
To investigate the prevalence of high- and low-pain responders defined by a PCS score 20 and 20 respectively as well as the acute postoperative course of pain for these groups after unicompartmental knee arthroplasty
Study location
The inclusion will take place at the Dept of Orthopaedic Surgery Arthroplasty unit at Hvidovre Hospital Capital Region of Denmark
Study plan
In the outpatient clinic the screening procedure will be performed among patients planned to UKA by the surgeons Patients will be asked if they may be contacted with the purpose of participating in a research project Patients will undergo a preliminary examination where as a standard procedure the patient will receive a PCS questionnaire Patients will be informed of the research project either in the outpatient clinic or by phone from an investigator
All patients will receive verbal and written information about the project All patients must give a signed informed consent on paper prior to inclusion to participate in the study
Data protection
All patient-related information will be treated confidentially and data will be pseudoanonymized Signed informed consent from participating patients will be stored at the Anesthesiologic Dept 542 Hvidovre Hospital in a locked cabinet All electronic data will be stored in REDCap
Collected variables
During the hospital stay data will be collected by contacting the patient at the Orthopaedic Dept and by accessing the electronic patient journal After discharge patients will be asked to fill out an electronic pain diary until 7 days after the operation
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