Chronic Postsurgical Pain: Multivariate Prediction Model

NCT06417528 | Recruiting

• 1 other identifier: CPoP
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Chronic Post Surgery Pain (CPSP)

  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.

  3 months

Secondary Outcomes (4)

• Pre operative factors

  60 to 1 day before the scheduled procedure

• Perioperative factors - before surgery

  The day of the scheduled surgery - before the surgery

• Perioperative factors - after surgery

  Immediately after the surgery to 48 hours after the surgery

• Post operative factors

  3 months after surgery

Other Outcomes (1)

• Development of the risk index

  6 months after the primary completion of the study

Study Arms (1)

Surgery Patients

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).

Procedure: Chronic Post Surgery Pain (CPSP)

Interventions

Chronic Post Surgery Pain (CPSP) PROCEDURE

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.

Surgery Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients undergoing any type of elective surgery

You may qualify if:

• Adult Patients
• Patients undergoing any type of elective surgery

You may not qualify if:

• Patients with sensory impairments
• Patients unable to communicate
• Patients with cognitive impairments
• Patients with insufficent knowledge of the language

Sponsors & Collaborators

• Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva: lead

Study Sites (1)

AOU G. Martino

Messina, Italy

RECRUITING

Related Publications (33)

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MeSH Terms

Conditions

Pain, Postoperative; Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Luigi Cardia, MD; PhD

CONTACT

+39 340 6946866; lcardia@unime.it

Alberto Noto, MD; PhD

CONTACT

alberto.noto@unime.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 19, 2024
• First Posted: May 16, 2024
• Study Start: December 14, 2022
• Primary Completion: December 14, 2024
• Study Completion: June 14, 2025
• Last Updated: May 16, 2024

Record last verified: 2024-05

Locations

IT (1)