Intrathecal Versus Epidural Morphine for Post-Cesarean Analgesia

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHospital Central do Funchal

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Intrathecal Morphine

    Drug

    Postoperative analgesia with intrathecal morphine 80 mcg

  • Epidural Morphine

    Drug

    Postoperative analgesia with epidural morphine 2.5mg

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: Intrathecal morphineExperimental treatment 1 intervention
Group B: Epidural morphineExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
Evaluation at 24 hours after surgery

Secondary outcomes

1

Total rescue opioid consumption

Time frame
Evaluation at 24 hours and 48 hours after surgery
2

Adverse effects associated with analgesia

To evaluate adverse effects associated with intrathecal versus epidural morphine administration, namely sedation, nausea, vomiting, and pruritus.

Time frame
Evaluation at 24 hours and 48 hours after surgery
3

Patients satisfaction with analgesia

Evaluated using the satisfaction-related items of the PAIN OUT questionnaire, scored on a Numeric Rating Scale.

Time frame
Evaluation at 24 hours and 48 hours after surgery
4

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.

Time frame
Evaluation at 48 hours after surgery

Other outcomes

Sponsors and contacts

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