Intrathecal versus epidural morphine for pain after cesarean delivery
Intrathecal Versus Epidural Morphine for Post-Cesarean Analgesia: A Randomized Controlled Trial
This test will compare a single intrathecal morphine shot versus epidural morphine for controlling pain in women having elective cesarean delivery.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Hospital Central do Funchal Academic / other |
| Locations | 1 site (Funchal, Madeira) |
| Trial ID | NCT07386353 on ClinicalTrials.gov |
What this trial studies
This unicentric randomized clinical trial will enroll pregnant women undergoing elective cesarean delivery at Hospital Central do Funchal. Participants will be randomly assigned to receive either 80 mcg intrathecal morphine at the end of surgery or epidural morphine given as a 2.5 mg bolus at the end of surgery with a second 2.5 mg bolus 24 hours later. The primary outcome is pain intensity during the first 24 postoperative hours, and secondary outcomes include pain at 48 hours, need for rescue analgesia, sedation, nausea/vomiting, pruritus, impact on mobilization and maternal satisfaction. Outcomes will be collected during the immediate postoperative period and up to 48 hours to compare analgesic effectiveness and side-effect profiles.
Who should consider this trial
Good fit: Ideal candidates are pregnant women over 18 scheduled for elective cesarean who can receive neuraxial anesthesia and provide informed consent.
Not a fit: Patients with opioid tolerance, contraindications to neuraxial anesthesia, significant renal impairment (GFR <60 mL/min), or ASA physical status >III are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If intrathecal morphine proves superior, patients could have better early post-cesarean pain control, reduced need for additional opioids, and easier newborn care.
How similar studies have performed: Previous studies are mixed—older trials favored epidural morphine while more recent evidence suggests intrathecal morphine may provide superior analgesia, but the data are limited and inconclusive.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Funchal, Madeira
- Hospital Central do Funchal — Funchal, Madeira, Portugal (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.