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UnknownNCT05739747

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
Phase
Study type
Observational
Enrollment
371 (estimated)
Sponsor
Consorci Sanitari de Terrassa · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers

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.

Conditions

Interventions

TypeNameDescription
OTHERQuestionnaireAll 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.
OTHERQuestionnaireThe 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
OTHERQuestionnaireThe 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.
OTHERQuestionnaire via telephone callAt 3 months, patients will be called and a structured questionnaire will be completed to assess the presence of chronic postoperative pain.
OTHERPhysical examinationThose 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.

Timeline

Start date
2023-04-01
Primary completion
2024-02-01
Completion
2025-02-01
First posted
2023-02-22
Last updated
2023-07-25

Locations

1 site across 1 country: Spain

Source: ClinicalTrials.gov record NCT05739747. Inclusion in this directory is not an endorsement.