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Recruiting Phase 4 NCT07386353

Intrathecal Versus Epidural Morphine for Post-Cesarean Analgesia

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Trial Parameters

Condition Analgesia Obstetrical
Sponsor Hospital Central do Funchal
Study Type INTERVENTIONAL
Phase Phase 4
Enrollment 120
Sex FEMALE
Min Age 18 Years
Max Age N/A
Start Date 2024-05-20
Completion 2026-07-31
Interventions
Intrathecal MorphineEpidural Morphine

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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.

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