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

Sponsor

Hospital Universitario La Fe (Other)

Overall Status

Recruiting

CT.gov ID

NCT05879536

Collaborator

(none)

312

Enrollment

Location

9.2

Anticipated Duration (Months)

33.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Post Operative Pain Cesarean Section Tramadol Postoperative Recovery Quality of Recovery Ondansetron QoR-15 ObsQor-10 Postcesarean Recovery	Drug: Tramadol-ondansetron continuous infusion Drug: Ropivacaine via epidural catheter

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 Design

Study Type:

Observational

Anticipated Enrollment :

312 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 23, 2023

Anticipated Primary Completion Date :

Feb 28, 2024

Anticipated Study Completion Date :

Feb 28, 2024

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

Post-surgical recovery [Day 1]
QoR-15 score at 24 hours after cesarean section

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 50 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Universitario La Fe	Valencia		Spain

Sponsors and Collaborators

Hospital Universitario La Fe

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Oscar Diaz-Cambronero, Principal Investigator. Head of the perioperative medicine group. Coordinator of the Clinical Medicine Unit, Hospital Universitario La Fe

ClinicalTrials.gov Identifier:

NCT05879536

Other Study ID Numbers:

TRON

First Posted:

May 30, 2023

Last Update Posted:

May 30, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Oscar Diaz-Cambronero, Principal Investigator. Head of the perioperative medicine group. Coordinator of the Clinical Medicine Unit, Hospital Universitario La Fe

postcesarean recovery

Additional relevant MeSH terms:

Study Results

No Results Posted as of May 30, 2023