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).
Study Type
OBSERVATIONAL
Enrollment
312
Analgesia strategy determined by routine use according to protocols, without investigator intervention.
Analgesia strategy determined by routine use according to protocols, without investigator intervention.
Hospital Universitario La Fe
Valencia, Spain
Post-surgical recovery
QoR-15 score at 24 hours after cesarean section
Time frame: Day 1
Analgesia for acute pain
Pain score evolution on the sequential Visual Analogue Scale at 24 hours, measured every 4 hours.
Time frame: Day 1
Adverse effects
Presence or absence of the next adverse effects: Pruritus; tremors; urinary retention or need for a bladder catheter; Constipation or abdominal distension; limitation of mobility; delayed initiation of breastfeeding if desired (due to analgesia); need for blood extraction for control analysis.
Time frame: Day 1
Quality of recovery using ObsQoR10 - Spanish version
ObsQor-10 score at 24 hours.
Time frame: Day 1
Post-surgical recovery
QoR-15 score at 48 hours after cesarean section
Time frame: Day 2
Adverse effects
Presence or absence of the next adverse effects: Pruritus; tremors; urinary retention or need for a bladder catheter; Constipation or abdominal distension; limitation of mobility; delayed initiation of breastfeeding if desired (due to analgesia); need for blood extraction for control analysis.
Time frame: Day 2
Analgesia for acute pain
Pain score evolution on the sequential Visual Analogue Scale at 48 hours, measured every 4 hours.
Time frame: Day 2
Chronic Pain
Chronic pain measured by numerical rating scale at 90 days of TRON versus AL-EPI.
Time frame: Day 90
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