Clinical trial

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

Name

TRON

Description

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.

Trial arms

Trial start

2023-05-23

Estimated PCD

2024-02-28

Trial end

2024-02-28

Status

Recruiting

Treatment

Tramadol-ondansetron continuous infusion

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

Arms:

TRON (Tramadol-Ondansetron)

Ropivacaine via epidural catheter

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

Arms:

AL-EPI (Local anesthetics via epidural)

Size

312

Primary endpoint

Post-surgical recovery

Day 1

Eligibility criteria

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

Protocol

{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 312, 'type': 'ESTIMATED'}}

Updated at

2023-05-30

1 organization

2 products

9 indications

Organization

Hospital Universitario La Fe

Product

Tramadol-Ondansetron

Indication

Postoperative Pain

Indication