Chronic Postsurgical Pain: Multivariate Prediction Model (CPoP)

May 11, 2024 updated by: Luigi Cardia, Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Luigi Cardia, MD; PhD
  • Phone Number: +39 340 6946866
  • Email: lcardia@unime.it

Study Contact Backup

Study Locations

  • Italy
      • Messina, Italy
        • Recruiting
        • AOU G. Martino
        • Contact:
          • Luigi Cardia, MD: PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Adult patients undergoing any type of elective surgery

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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)

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pre operative factors
Time Frame: 60 to 1 day before the scheduled procedure

  • Age

    • 18-35
    • 36-55
    • ≥55

  • Sex

    • Female
    • Male

  • BMI

    • ≤18.5 - 24.9
    • 25 - 29.9
    • ≥30
  • Alcohol or substances of abuse (Y/N) (specify the substance)
  • Previous experience of pain NRS ≥5 for 7 days (Y/N)
  • Presence of chronic pathologies (Y/N) (if yes, provide the list of medications)
  • Pharmacological treatments including supplements or nutraceuticals (continuous in the last 3 months) (Y/N) (if yes, provide the list of drugs)
  • Chronic pain (NRS ≥3 for ≥3 months) (Y/N)
  • Neuropathic pain (Y/N) (assessment using Douleur Neuropathique en 4 questions DN-4 questionnaire)
  • Pain catastrophizing (Y/N) (assessment via Pain Catastrophizing Scale PCS questionnaire)
  • Anxiety (Y/N) (assessment using General Anxiety Disorder-7 GAD-7 questionnaire)
  • Depression (Y/N) (assessment using Beck Depression Inventory BDI-II questionnaire)
  • Presence of pain in the last three days (NRS ≥3 mean pain intensity in the 24 hours) (Y/N)
60 to 1 day before the scheduled procedure
Perioperative factors - before surgery
Time Frame: The day of the scheduled surgery - before the surgery

  • Site of surgery

    • Head
    • Vertebral column
    • Arms/legs
    • Chest
    • Abdomen
    • Genitourinary system

  • Surgical technique

    • Open surgery
    • Minimally invasive surgery
    • Robotic surgery
  • ERAS (enhanced recovery after surgery) protocol (Y/N)

  • Anesthesiologic technique

    • General Anesthesia
    • Spinal Anesthesia
    • Epidural Anesthesia
    • Peripheral nerve block
  • Preventive/protective analgesia (Y/N)
  • Premedication (Y/N)
  • OFA opioid-free anesthesia protocol (Y/N)
  • Postoperative analgesic prescription (Y/N)
The day of the scheduled surgery - before the surgery
Perioperative factors - after surgery
Time Frame: Immediately after the surgery to 48 hours after the surgery
  • Pain NRS score ≥3 at the end of the surgery (Y/N)
  • Presence of pain (NRS ≥5 - average value in the 24 hours) in the region of the operation at rest or during movement after surgery (Y/N)

  • Analgesic prescription after surgery

    • ≤12 hours of coverage
    • 13-24 hours of coverage
    • ≥ 24 hours of coverage
  • Postoperative surgical complications (Y/N)
  • Postoperative infectious complications (Y/N)
  • Mobilization after surgery ≤6 hours? (Y/N)
Immediately after the surgery to 48 hours after the surgery
Post operative factors
Time Frame: 3 months after surgery
  • Pain assessment: average pain intensity assessed using a standard NRS scale (the cutoff score will be set at ≥3 mean pain intensity over the last three days ) (Y/N).
  • Diagnosis of CPSP (the pain is localized in the surgical field or in the area of the lesion, projected into the innervation territory of a nerve located in this area, or referred to a dermatome) (Y/N)
  • Surgical complications (Y/N)
  • Infectious complications related to surgery (Y/N)
  • Malignancy (Y/N)
  • Neuropathic pain (Y/N) (assessed using Douleur Neuropathique in 4 questions DN-4 questionnaire)
3 months after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Development of the risk index
Time Frame: 6 months after the primary completion of the study
  • Primary version of the risk index, made up of items derived from a systematic bibliographic search (compilation of the item pool).
  • Authors will analyze the associations between each of these indices and the probability of CPSP 3 months after surgery (dichotomous variable), evaluated using logistic regression models.
  • Items that were found to be significant in the bivariate analyses will then be analyzed multivariately (logistic regression models).
  • Authors will safeguard the results of the multivariate analyses by calculating the area under the ROC curve of the model, and then, the cut-off score for a high risk of developing CPSP will be identified with an optimal compromise between sensitivity and specificity.
  • The items that will generate significant predictive factors in the logistic regression analyses will be collected into an index. For each value of this index, the Authors will calculate the proportion of patients who reported CPSP at 3 months after surgery.
6 months after the primary completion of the study

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Societa Italiana Anestesia Analgesia Rianimazione e Terapia Intensiva

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 14, 2022

Primary Completion (Estimated)

December 14, 2024

Study Completion (Estimated)

June 14, 2025

Study Registration Dates

First Submitted

March 19, 2024

First Submitted That Met QC Criteria

May 11, 2024

First Posted (Actual)

May 16, 2024

Study Record Updates

Last Update Posted (Actual)

May 16, 2024

Last Update Submitted That Met QC Criteria

May 11, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CPoP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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