An observational study in Chronic Post Surgical Pain, Cesarean Section Complications and Chronic Pain, sponsored by Consorci Sanitari de Terrassa. Recruiting at 1 site in Spain. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-07-25.
Sponsored by Consorci Sanitari de Terrassa · Observational
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.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's planned enrollment of 371 is above the median of 102 across 608 observational studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Consorci Sanitari de Terrassa is the lead sponsor of 41 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients undergoing elective cesarean section.
Exclusion Criteria
informed consent.
This study is designed with a single cohort of women who will undergo a scheduled cesarean section
Other: Questionnaire · Other: Questionnaire via telephone call · Other: Physical examination
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.
The 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
The 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.
At 3 months, patients will be called and a structured questionnaire will be completed to assess the presence of chronic postoperative pain.
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.
Gendolcat score
The Gendolcat score assesses the likelihood of suffering chronic post-surgical pain
Time frame: The Gendolcat score will be assessed on the day patients are included in the study
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.
Time frame: Done during physical examination will be performed 3 months after cesarean section.
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
Time frame: Done during physical examination will be performed 3 months after cesarean section.
Short Edition of the Brief Pain Inventory
Rapidly assesses the severity of pain and its impact on functioning
Time frame: Done during physical examination will be performed 3 months after cesarean section.
DN4 Questionnaire
To estimate the probability of neuropathic pain
Time frame: Done during physical examination will be performed 3 months after cesarean section.
Plan to share: No
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Consorci Sanitari de Terrassa