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Clinical Trials/NCT05739747
NCT05739747RecruitingNot Applicable

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

Consorci Sanitari de Terrassa1 site in 1 country371 target enrollmentStarted: April 1, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Sponsor
Enrollment
371
Locations
1
Primary Endpoint
Short Edition of the Brief Pain Inventory

Study Overview

Brief Summary

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 Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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.

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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

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

DN4 Questionnaire

Time Frame: Done during physical examination will be performed 3 months after cesarean section.

To estimate the probability of neuropathic pain

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

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Consorci Sanitari de Terrassa
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Carles Espinos Ramírez

M.D.

Consorci Sanitari de Terrassa

Study Sites (1)

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