NCT07386353 Intrathecal Versus Epidural Morphine for Post-Cesarean Analgesia
| NCT ID | NCT07386353 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Hospital Central do Funchal |
| Condition | Analgesia Obstetrical |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-05-20 |
| Primary Completion | 2026-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 120 participants in total. It began in 2024-05-20 with a primary completion date of 2026-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Cesarean section is one of the most commonly performed surgical procedures worldwide, making effective management of acute postoperative pain a key issue in obstetric anesthesiology. Post-cesarean analgesia should promote rapid maternal recovery, support newborn care, and consider the pharmacological implications for breastfeeding. According to recent PROSPECT® guidelines from ESRA, neuraxial opioids play a central role in post-cesarean analgesia and are at least as effective as other techniques, such as continuous local anesthetic infusion. However, the optimal route of opioid administration remains unclear. While earlier studies favored epidural morphine, more recent evidence suggests that intrathecal morphine may provide superior analgesia. Due to limited and conflicting data, no definitive conclusion can be drawn. Given that epidural morphine remains standard practice at Hospital Central do Funchal, a randomized clinical trial is proposed to compare the analgesic efficacy of intrathecal versus epidural morphine after elective cesarean section.
Eligibility Criteria
Inclusion Criteria: * Pregnant women scheduled for elective cesarean section; * Age \> 18 years; * Willingness to participate in the study, as demonstrated by signed informed consent. Exclusion Criteria: * American Society of Anesthesiologists (ASA) physical status classification \> III; * Chronic kidney disease with a glomerular filtration rate \< 60 mL/min; * Relevant drug allergies (particularly to protocol medications); * Opioid tolerance; * Contraindication to neuraxial anesthetic techniques.
Frequently Asked Questions
Who can join the NCT07386353 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Analgesia Obstetrical. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07386353 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT07386353 currently recruiting?
Yes, NCT07386353 is actively recruiting participants. Visit ClinicalTrials.gov or contact Hospital Central do Funchal to inquire about joining.
Where is the NCT07386353 trial being conducted?
This trial is being conducted at Funchal, Portugal.
Who is sponsoring the NCT07386353 clinical trial?
NCT07386353 is sponsored by Hospital Central do Funchal. The trial plans to enroll 120 participants.