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The Effect of Intravenous Infusion of Tramadol-ondansetron on Recovery After Caesarean Section. A Prospective, Observational and Non-inferiority Study Against Epidural Analgesia.
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.
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).
Age
18 - 50 years
Sex
FEMALE
Healthy Volunteers
Yes
Hospital Universitario La Fe
Valencia, Spain
Start Date
May 23, 2023
Primary Completion Date
October 1, 2024
Completion Date
October 1, 2024
Last Updated
February 21, 2025
312
ACTUAL participants
Tramadol-ondansetron continuous infusion
DRUG
Ropivacaine via epidural catheter
DRUG
Lead Sponsor
Hospital Universitario La Fe
NCT07482709
NCT07041736
Data Source & Attribution
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View ClinicalTrials.gov Terms and ConditionsNCT06357546