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Chronic Postsurgical Pain: Multivariate Prediction Model (CPoP)

S

Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva

Status

Enrolling

Conditions

Postoperative Pain, Chronic
Post Surgical Pain
Post Operative Pain

Treatments

Procedure: Chronic Post Surgery Pain (CPSP)

Study type

Observational

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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.

Enrollment

1,500 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

1,500 participants in 1 patient group

Surgery Patients
Description:
Data collection will record parameters of patients undergoing surgery at four different times: preoperative assessment (60 to 1 day before the scheduled procedure); evaluation of the perioperative period; and postoperative period (from the third month following surgery).
Treatment:
Procedure: Chronic Post Surgery Pain (CPSP)

Trial documents
1

Trial contacts and locations

1

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Central trial contact

Alberto Noto, MD; PhD; Luigi Cardia, MD; PhD

Data sourced from clinicaltrials.gov

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