Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06417528
Status:
RECRUITING
Last Update Posted:
2024-05-16
First Post:
2024-03-19
Brief Title:
Chronic Postsurgical Pain Multivariate Prediction Model
Sponsor:
Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva
Organization:
Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva
Study Overview
Official Title:
Chronic Postsurgical Pain Multivariate Prediction Model
Status:
RECRUITING
Status Verified Date:
2024-05
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:
CPoP
Brief Summary:
The goal of this observational study is to identify the risk factors of Chronic Postoperative pain or Chronic Post Surgery Pain - CPSP three months after surgery and subsequently the development of a risk index to identify high-risk patients considering the multifactorial etiology of CPOP in adult patients undergoing any type of elective surgery
Detailed Description:
The study aims to identify the risk factors of CPSP three months after surgery and subsequently develop a risk index to identify high-risk patients considering the multifactorial etiology of CPSP
A comprehensive entry pool was derived from a systematic literature search Data collection will record parameters at four different time points preoperative assessment 60 to 1 day before the scheduled procedure evaluation of the perioperative period postoperative period from the third month after the operation
The outcome variable is the presence of CPSP assessed 3 months postoperatively and defined as a mean pain intensity of at least 3 on the NRS one-dimensional pain scale from 0 to 10 over the past three days and pain localized to the field surgical or to the area of the lesion projected into the innervation territory of a nerve located in this area or referred to a dermatome
Four separate forecasting models will be developed using data derived from surveys carried out at relevant time points for the development of the risk index
A comprehensive entry pool was derived from a systematic literature search Data collection will record parameters at four different time points preoperative assessment 60 to 1 day before the scheduled procedure evaluation of the perioperative period postoperative period from the third month after the operation
The outcome variable is the presence of CPSP assessed 3 months postoperatively and defined as a mean pain intensity of at least 3 on the NRS one-dimensional pain scale from 0 to 10 over the past three days and pain localized to the field surgical or to the area of the lesion projected into the innervation territory of a nerve located in this area or referred to a dermatome
Four separate forecasting models will be developed using data derived from surveys carried out at relevant time points for the development of the risk index
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