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Clinical Trial Summary

It will be a prospective observational cohort study. The investigators will compare post-cesarean section recovery in patients receiving intravenous infusion of tramadol-ondansetron versus epidural catheter with infusion of local anesthetics.


Clinical Trial Description

The primary outcome is to assess the non-inferiority in terms of post-cesarean section recovery of the intravenous perfusion of tramadol + ondansetron compared to the perfusion of local anesthetics through an epidural catheter. This will be a prospective observational cohort study, with a total N of 312 patients who underwent a cesarean section. 156 who maintain the epidural catheter as the main measure of analgesia for 24 h, and 156 who receive an infusion of tramadol-ondansetron from the end of the cesarean section and for the following 24 h. The following data will be collected at 24 and 48 hours: need for unscheduled pharmacological reinforcement, adverse effects, QoR (Quality of Recovery) score 15, ObsQor-10 (Obstetric Quality of Recovery) score, and Visual Analogue Pain Scale (VAS) every 4 hours for 48 hours. The incidence of chronic pain 90 days after cesarean section will be assessed using the Numerical Pain Rating Scale (NRS). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05879536
Study type Observational
Source Hospital Universitario La Fe
Contact Jose Daniel Jimenez Santana, Resident
Phone +34629826331
Email jimenez_josedanielsan@gva.es
Status Recruiting
Phase
Start date May 23, 2023
Completion date February 28, 2024

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