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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05739747
Enrollment
371
Registered
2023-02-22
Start date
2023-04-01
Completion date
2025-02-28
Last updated
2023-07-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section Complications, Chronic Pain, Chronic Post Surgical Pain

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.

Interventions

OTHERQuestionnaire

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.

OTHERQuestionnaire 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.

OTHERPhysical 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.

Sponsors

Consorci Sanitari de Terrassa
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum

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.

Design outcomes

Primary

MeasureTime frameDescription
Gendolcat scoreThe Gendolcat score will be assessed on the day patients are included in the studyThe Gendolcat score assesses the likelihood of suffering chronic post-surgical pain
Categoric Pain ScaleDone 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.
Numeric Pain ScaleDone 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
Short Edition of the Brief Pain InventoryDone during physical examination will be performed 3 months after cesarean section.Rapidly assesses the severity of pain and its impact on functioning
DN4 QuestionnaireDone during physical examination will be performed 3 months after cesarean section.To estimate the probability of neuropathic pain

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026