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

May 26, 2023 updated by: Oscar Diaz-Cambronero, Hospital Universitario La Fe

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

312

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
      • Valencia, Spain
        • Recruiting
        • Hospital Universitario La Fe
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Analgesia strategy determined by routine use according to protocols, without investigator intervention.
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
Analgesia strategy determined by routine use according to protocols, without investigator intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post-surgical recovery
Time Frame: Day 1
QoR-15 score at 24 hours after cesarean section
Day 1

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Universitario La Fe

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 23, 2023

Primary Completion (Estimated)

February 28, 2024

Study Completion (Estimated)

February 28, 2024

Study Registration Dates

First Submitted

April 4, 2023

First Submitted That Met QC Criteria

May 26, 2023

First Posted (Actual)

May 30, 2023

Study Record Updates

Last Update Posted (Actual)

May 30, 2023

Last Update Submitted That Met QC Criteria

May 26, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TRON

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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