Chronic Postsurgical Pain: Multivariate Prediction Model
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Post Surgical Pain
- Sponsor
- Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva
- Enrollment
- 1500
- Locations
- 1
- Primary Endpoint
- Chronic Post Surgery Pain (CPSP)
- Status
- Recruiting
- Last Updated
- last year
Overview
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.
Investigators
Luigi Cardia
Principal Investigator
Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva
Eligibility Criteria
Inclusion Criteria
- •Adult Patients
- •Patients undergoing any type of elective surgery
Exclusion Criteria
- •Patients with sensory impairments
- •Patients unable to communicate
- •Patients with cognitive impairments
- •Patients with insufficent knowledge of the language
Outcomes
Primary Outcomes
Chronic Post Surgery Pain (CPSP)
Time Frame: 3 months
Presence of CPSP assessed 3 months after surgery and defined as an average pain intensity of at least 3 points on the NRS scale (one-dimensional pain scale - from 0 to 10 points) 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.
Secondary Outcomes
- Pre operative factors(60 to 1 day before the scheduled procedure)
- Perioperative factors - before surgery(The day of the scheduled surgery - before the surgery)
- Post operative factors(3 months after surgery)
- Perioperative factors - after surgery(Immediately after the surgery to 48 hours after the surgery)