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Completed

NCT Number: NCT05879536

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

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.

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tramadol-ondansetron continuous infusion

Drug

Analgesia strategy determined by routine use according to protocols, without investigator intervention.

Ropivacaine via epidural catheter

Drug

Analgesia strategy determined by routine use according to protocols, without investigator intervention.

Primary outcomes

  1. Post-surgical recovery

    Time frame: Day 1

    QoR-15 score at 24 hours after cesarean section

Secondary outcomes

  1. Analgesia for acute pain

    Time frame: Day 1

    Pain score evolution on the sequential Visual Analogue Scale at 24 hours, measured every 4 hours.

  2. Adverse effects

    Time frame: Day 1

    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.

  3. Quality of recovery using ObsQoR10 - Spanish version

    Time frame: Day 1

    ObsQor-10 score at 24 hours.

  4. Post-surgical recovery

    Time frame: Day 2

    QoR-15 score at 48 hours after cesarean section

  5. Adverse effects

    Time frame: 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.

  6. Analgesia for acute pain

    Time frame: Day 2

    Pain score evolution on the sequential Visual Analogue Scale at 48 hours, measured every 4 hours.

  7. Chronic Pain

    Time frame: Day 90

    Chronic pain measured by numerical rating scale at 90 days of TRON versus AL-EPI.

Sponsors and collaborators

Lead sponsor

Hospital Universitario La Fe

Other

Registry information

Official study title

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

Acronym: TRON

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 30, 2023
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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