Chronic Pain Clinical Trial
Official title:
Validation of the Gendolcat Score for the Prognosis of Chronic Postoperative Pain in Cesarean Section.
NCT number | NCT05739747 |
Other study ID # | 02-23-270-003 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | April 1, 2023 |
Est. completion date | February 2025 |
Verified date | July 2023 |
Source | Consorci Sanitari de Terrassa |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Recruiting |
Enrollment | 371 |
Est. completion date | February 2025 |
Est. primary completion date | February 2024 |
Accepts healthy volunteers | |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitari Germans Trias i Pujol | Badalona | Barcelona |
Lead Sponsor | Collaborator |
---|---|
Consorci Sanitari de Terrassa |
Spain,
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* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Gendolcat score | 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 | |
Primary | Categoric Pain Scale | 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. | |
Primary | Numeric Pain Scale | 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. | |
Primary | Short Edition of the Brief Pain Inventory | Rapidly assesses the severity of pain and its impact on functioning | Done during physical examination will be performed 3 months after cesarean section. | |
Primary | DN4 Questionnaire | To estimate the probability of neuropathic pain | Done during physical examination will be performed 3 months after cesarean section. |
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