About this trial
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
This trial accepts healthy volunteersQualifiers
Pregnant women scheduled for elective cesarean section;
Age > 18 years;
Willingness to participate in the study, as demonstrated by signed informed consent.
Disqualifiers
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;
Trial design
Parallel
Treatments tested in this trial
Intrathecal Morphine
DrugPostoperative analgesia with intrathecal morphine 80 mcg
Epidural Morphine
DrugPostoperative analgesia with epidural morphine 2.5mg
Treatment groups
Trial outcomes
Primary outcomes
Postoperative pain control
Comparison between intrathecal morphine versus epidural morphine analgesia assessed using the Numeric Rating Scale (NRS) as part of the PAIN OUT questionnaire.
Secondary outcomes
Total rescue opioid consumption
Adverse effects associated with analgesia
To evaluate adverse effects associated with intrathecal versus epidural morphine administration, namely sedation, nausea, vomiting, and pruritus.
Patients satisfaction with analgesia
Evaluated using the satisfaction-related items of the PAIN OUT questionnaire, scored on a Numeric Rating Scale.
Postoperative pain control
Comparison between intrathecal morphine versus epidural morphine analgesia assessed using the Numeric Rating Scale (NRS) as part of the PAIN OUT questionnaire.
Sponsors and contacts
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