NCT06417528

Chronic Postsurgical Pain: Multivariate Prediction Model

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,500 (estimated)
• Sponsor: Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Post Surgical Pain
• Post Operative Pain
• Postoperative Pain, Chronic

Interventions

Type	Name	Description
PROCEDURE	Chronic Post Surgery Pain (CPSP)	The outcome variable is the presence of CPSP assessed 3 months after surgery and defined as an average pain intensity of at least 3 on the NRS scale (11-point one-dimensional pain scale) in the last three days, and pain localized to the surgical field (or in the lesion area) projected into the innervation territory of a nerve located in this area or referred to a dermatome. Separate prediction models will be developed using data derived from surveys conducted at the relevant time points for the development of the risk index.

Timeline

• Start date: 2022-12-14
• Primary completion: 2024-12-14
• Completion: 2025-06-14
• First posted: 2024-05-16
• Last updated: 2024-05-16

Locations

1 site across 1 country: Italy