Clinical trial NCT06417528: Chronic Postsurgical Pain: Multivariate Prediction Model
Official title: Chronic Postsurgical Pain: Multivariate Prediction Model
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Post Surgical Pain
Post Operative Pain
Postoperative Pain, Chronic
Keywords: Pain
Chronic Pain
Postoperative Pain
Post Operative Pain
Post Surgical Pain
Multivariate Prediction Model
Prediction Model
Lead sponsor: Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva
Sponsor class: OTHER
First posted: 2024-05-16
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients undergoing any type of elective surgery

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.

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

Primary outcomes:
measure: Chronic Post Surgery Pain (CPSP)
timeFrame: 3 months
Secondary outcomes:
measure: Pre operative factors
timeFrame: 60 to 1 day before the scheduled procedure
measure: Perioperative factors - before surgery
timeFrame: The day of the scheduled surgery - before the surgery
measure: Perioperative factors - after surgery
timeFrame: Immediately after the surgery to 48 hours after the surgery
measure: Post operative factors
timeFrame: 3 months after surgery
Other outcomes:
measure: Development of the risk index
timeFrame: 6 months after the primary completion of the study
Locations:
city: Messina
country: Italy
facility: AOU G. Martino
Study officials:
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