NCT05879536

The Effect of Intravenous Infusion of Tramadol-ondansetron on Recovery After Caesarean Section.

The Effect of Intravenous Infusion of Tramadol-ondansetron on Recovery After Caesarean Section. A Prospective, Observational and Non-inferiority Study Against Epidural Analgesia.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 312 (actual)
• Sponsor: Hospital Universitario La Fe · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed 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).

Conditions

• Post Operative Pain
• Cesarean Section
• Tramadol
• Postoperative Recovery
• Quality of Recovery
• Ondansetron
• QoR-15
• ObsQor-10
• Postcesarean Recovery

Interventions

Type	Name	Description
DRUG	Tramadol-ondansetron continuous infusion	Analgesia strategy determined by routine use according to protocols, without investigator intervention.
DRUG	Ropivacaine via epidural catheter	Analgesia strategy determined by routine use according to protocols, without investigator intervention.

Timeline

• Start date: 2023-05-23
• Primary completion: 2024-10-01
• Completion: 2024-10-01
• First posted: 2023-05-30
• Last updated: 2025-02-21

Locations

1 site across 1 country: Spain