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

Completed

• Conditions: Post Operative Pain; Cesarean Section; Tramadol; Postoperative Recovery; Quality of Recovery; Ondansetron; QoR-15; Postcesarean Recovery; ObsQor-10
• Interventions: Drug: Tramadol-ondansetron continuous infusion; Drug: Ropivacaine via epidural catheter

• Registration Number: NCT05879536
• Lead Sponsor: Hospital Universitario La Fe

Brief 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).

Study Timeline

• Study First Submitted: 2023-04-04
• Study Start: 2023-05-23
• Study First Submitted QC: 2023-05-26
• Study First Posted: 2023-05-30
• Primary Completion: 2024-10-01
• Study Completion: 2024-10-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 312

Inclusion Criteria

• Woman over 18 years old undergoing caesarean section
• She agrees to participate voluntarily.
• She is already receiving any of the analgesic strategies studied.

Exclusion Criteria

• Receiving an analgesic medication other than the one mentioned as "routine multimodal analgesia" (either as regular medication or for acute post-surgical pain)
• Medical history that determines the baseline data of the scales and data that we collect ( pain or previous disabilities; addiction to drugs, alcohol or drugs; another disease that worsens the quality of life)
• Medical history that conditions the pharmacological effect (allergy, intolerance or atypical reaction to any of the drugs involved in its treatment or possible cross-reactions )
• Contraindication for neuraxial techniques (patient refusal, difficulty in understanding or communication, localized infection, increased intracranial pressure, or other medical criteria)
• Two or more previous caesarean sections
• Difficulty in understanding or communication
• Mother care will not be available to the newborn in the postpartum period for any reason

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
TRON (Tramadol-Ondansetron)	Tramadol-ondansetron continuous infusion	Women who receive an infusion of tramadol-ondansetron from the end of the cesarean section and for the following 24 h. The infusion (TRON) is composed of 300 mg of tramadol and 12 mg of ondansetron dissolved in 250 ml of 0.9% saline, which is routinely programmed at 11 ml/h until the content is exhausted (approximately 23 hours).
AL-EPI (Local anesthetics via epidural)	Ropivacaine via epidural catheter	Women who maintain the epidural catheter as the main measure of analgesia for 24 h. The epidural catheter after caesarean section is programmed with a 0.2% ropivacaine PCA (Patient controlled analgesia) pump at 7 ml/h with 7 ml on-demand boluses, with block every 20 min.

Primary Outcome Measures

Name	Time	Method
Post-surgical recovery	Day 1	QoR-15 score at 24 hours after cesarean section

Secondary Outcome Measures

Name	Time	Method
Analgesia for acute pain	Day 2	Pain score evolution on the sequential Visual Analogue Scale at 48 hours, measured every 4 hours.
Quality of recovery using ObsQoR10 - Spanish version	Day 1	ObsQor-10 score at 24 hours.
Adverse effects	Day 2	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.
Post-surgical recovery	Day 2	QoR-15 score at 48 hours after cesarean section
Chronic Pain	Day 90	Chronic pain measured by numerical rating scale at 90 days of TRON versus AL-EPI.

Trial Locations

Locations (1)

Hospital Universitario La Fe; 🇪🇸 Valencia, Spain