Validation of the Gendolcat Score for the Prognosis of Chronic Postoperative Pain in Cesarean Section

July 23, 2023 updated by: Carles Espinos Ramírez, Consorci Sanitari de Terrassa

Validation of the Gendolcat Score for the Prognosis of Chronic Postoperative Pain in Cesarean Section.

Chronic post-surgical pain is a problem that has historically been underestimated. Over the last few years there has been a search for strategies to both predict and prevent its occurrence in patients undergoing surgery. The Gendolcat index is the only predictive model that uses only objective pre-surgical variables to assess the risk of suffering chronic post-surgical pain. However, it is only validated for the following surgeries: thoracotomy, hysterectomy and open inguinal hernia. Our aim is to test whether the Gendolcat model is also valid for cesarean section.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

371

Contacts and Locations

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

Study Locations

  • Spain
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
        • Recruiting
        • Hospital Universitari Germans Trias i Pujol
        • Contact:

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing elective cesarean section.

Description

Inclusion Criteria:

  • Patients who underwent elective caesarean section.
  • Patients who have previously signed the informed consent form.

Exclusion Criteria

  • Urgent cesarean section.
  • Patients with severe psychiatric pathology.
  • Patients who require a different surgical approach than usual.
  • Patients who refuse to take part in the study and/or to sign the informed consent form.

informed consent.

- Patients with a high language barrier.

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
Women undergoing cesarean section
This study is designed with a single cohort of women who will undergo a scheduled cesarean section
Other: Questionnaire

All patients should complete the following questionnaires:

On the day of surgery:

  • Patient registration.
  • Complete medical history.
  • Gendolcat scale (including the Spanish version of the SF-12 scale).
  • Spanish version of the catastrophizing scale.
Other: Questionnaire
The investigators should complete a questionnaire during the surgical procedure specifying the anesthetic technique used, drugs and doses used and record any incident during the surgical procedure
Other: Questionnaire
The investigators should complete a questionnaire 24 hours after surgery to assess the possible presence of postoperative pain as well as the intensity and need for rescue analgesia.
Other: Questionnaire via telephone call
At 3 months, patients will be called and a structured questionnaire will be completed to assess the presence of chronic postoperative pain.
Other: Physical examination
Those women who, after the telephone call, are considered to have chronic post-surgical pain will undergo a physical examination to confirm it. The type of pain and its intensity will also be evaluated. The impact on their daily physical activity and quality of life will be evaluated by means of a questionnaire.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gendolcat score
Time Frame: The Gendolcat score will be assessed on the day patients are included in the study
The Gendolcat score assesses the likelihood of suffering chronic post-surgical pain
The Gendolcat score will be assessed on the day patients are included in the study
Categoric Pain Scale
Time Frame: Done during physical examination will be performed 3 months after cesarean section.
These pain scales give people a simple way to rate their pain intensity using a verbal or visual descriptor of their pain.
Done during physical examination will be performed 3 months after cesarean section.
Numeric Pain Scale
Time Frame: Done during physical examination will be performed 3 months after cesarean section.
Patients are asked to circle the number between 0 and 10, 0 and 20 or 0 and 100 that fits best to their pain intensity
Done during physical examination will be performed 3 months after cesarean section.
Short Edition of the Brief Pain Inventory
Time Frame: Done during physical examination will be performed 3 months after cesarean section.
Rapidly assesses the severity of pain and its impact on functioning
Done during physical examination will be performed 3 months after cesarean section.
DN4 Questionnaire
Time Frame: Done during physical examination will be performed 3 months after cesarean section.
To estimate the probability of neuropathic pain
Done during physical examination will be performed 3 months after cesarean section.

Collaborators and Investigators

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

Sponsor

Consorci Sanitari de Terrassa

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)

April 1, 2023

Primary Completion (Estimated)

February 1, 2024

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

February 5, 2023

First Submitted That Met QC Criteria

February 13, 2023

First Posted (Actual)

February 22, 2023

Study Record Updates

Last Update Posted (Actual)

July 25, 2023

Last Update Submitted That Met QC Criteria

July 23, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02-23-270-003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Clinical Trials on Chronic Pain

Clinical Trials on Questionnaire

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Uganda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe