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

NCT05879536 | Completed

• 1 other identifier: TRON
• Study Type: observational
• Target: 312
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

tramadol; cesarean section; postcesarean section; Qor-15; ObsQor-10; postcesarean recovery

Outcome Measures

Primary Outcomes (1)

• Post-surgical recovery

  QoR-15 score at 24 hours after cesarean section

  Day 1

Secondary Outcomes (7)

• Analgesia for acute pain

  Day 1

• Adverse effects

  Day 1

• Quality of recovery using ObsQoR10 - Spanish version

  Day 1

• Post-surgical recovery

  Day 2

• Adverse effects

  Day 2

Study Arms (2)

TRON (Tramadol-Ondansetron)

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).

Drug: Tramadol-ondansetron continuous infusion

AL-EPI (Local anesthetics via epidural)

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.

Drug: Ropivacaine via epidural catheter

Interventions

Tramadol-ondansetron continuous infusion DRUG

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

TRON (Tramadol-Ondansetron)

Ropivacaine via epidural catheter DRUG

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

AL-EPI (Local anesthetics via epidural)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The target population of this study would correspond to women who underwent a caesarean section (therefore, of childbearing age) in the first 48 hours of their puerperium, who underwent surgery at the HUiP La Fe. Among these, the patients who, following the practice usual clinical presentation in a standard cesarean section at the study center, receive a TRON or an infusion through the epidural catheter with ropivacaine.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Universitario La Fe: lead

Study Sites (1)

Hospital Universitario La Fe

Valencia, Spain

Location

Related Publications (28)

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MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator. Head of the perioperative medicine group. Coordinator of the Clinical Medicine Unit

Study Record Dates

• First Submitted: April 4, 2023
• First Posted: May 30, 2023
• Study Start: May 23, 2023
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: February 21, 2025

Record last verified: 2025-02

Locations

ES (1)