Clinical trial NCT05739747: Validation of the Gendolcat Score for the Prognosis of Chronic Postoperative Pain in Cesarean Section
Official title: Validation of the Gendolcat Score for the Prognosis of Chronic Postoperative Pain in Cesarean Section.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Post Surgical Pain
Cesarean Section Complications
Chronic Pain
Lead sponsor: Consorci Sanitari de Terrassa
Sponsor class: OTHER
First posted: 2023-02-22
Enrollment: 371
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing elective cesarean section.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Gendolcat score
timeFrame: The Gendolcat score will be assessed on the day patients are included in the study
measure: Categoric Pain Scale
timeFrame: Done during physical examination will be performed 3 months after cesarean section.
measure: Numeric Pain Scale
timeFrame: Done during physical examination will be performed 3 months after cesarean section.
measure: Short Edition of the Brief Pain Inventory
timeFrame: Done during physical examination will be performed 3 months after cesarean section.
measure: DN4 Questionnaire
timeFrame: Done during physical examination will be performed 3 months after cesarean section.
Secondary outcomes:
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
Study officials:
References:
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