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

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

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

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

Intervention / Treatment
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* Drug: Tramadol-ondansetron continuous infusion
* Drug: Ropivacaine via epidural catheter


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TRON (Tramadol-Ondansetron)<br>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<br>* Analgesia strategy determined by routine use according to protocols, without investigator intervention.<br>|
| AL-EPI (Local anesthetics via epidural)<br>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<br>* Analgesia strategy determined by routine use according to protocols, without investigator intervention.<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tramadol, cesarean section, postcesarean section, Qor-15, ObsQor-10, postcesarean recovery