Optimal spinal morphine dose for pain after cesarean delivery
Determination of the Optimal Dose of Intrathecal Morphine for Postoperative Analgesia After Cesarean Section Using the Up-and-Down Sequential Allocation Method
This will test different doses of morphine given into the spinal fluid to find the best dose for reducing pain after an elective cesarean in adult women.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | Female |
| Sponsor | University of Ioannina Academic / other |
| Locations | 1 site (Ioannina, Epirus) |
| Trial ID | NCT07023497 on ClinicalTrials.gov |
What this trial studies
Adult women having elective, term, singleton cesarean deliveries who meet strict inclusion criteria will receive intrathecal morphine added to their spinal anesthesia at varying doses. Pain intensity, need for additional analgesics, and opioid-related side effects (for example respiratory depression, nausea, pruritus, and constipation) will be recorded in the immediate postoperative period. Participants with chronic pain, recent opioid use, urgent cesarean delivery, or contraindications to spinal anesthesia are excluded. The study is conducted at the University Hospital of Ioannina and focuses on balancing effective analgesia with minimal side effects.
Who should consider this trial
Good fit: Ideal candidates are adult, term parturients with a singleton pregnancy scheduled for elective cesarean delivery who are ASA II and have no history of chronic pain or opioid use.
Not a fit: Patients who are under 18, in labor, having an urgent cesarean, with chronic opioid use, serious cardiac/hepatic/renal disease, allergy to morphine, or other contraindications to spinal anesthesia are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the study could identify a dose of intrathecal morphine that provides better post-cesarean pain control with fewer opioid side effects.
How similar studies have performed: Previous studies show intrathecal morphine reliably improves post-cesarean analgesia, but the optimal dose to maximize benefit while minimizing side effects remains incompletely defined.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * term parturient * single pregnancy * elective cesarean delivery * adult parturient * ASA II Exclusion Criteria: * participants under the age of 18 * extreme somatometric characteristics * lack of patient consent * absolute contraindications for spinal anesthesia * urgent cesarean section * presence of known fetal anomalies * onset of labor prior to administration of the block * history of chronic pain * use of opioids (systemic or otherwise) for any reason (e.g., chronic malignant pain) * communication difficulties (e.g., language barriers, cognitive impairments) * allergy or hypersensitivity to morphine * severe arrhythmia or other serious cardiovascular conditions * severe hepatic or renal insufficiency
Where this trial is running
Ioannina, Epirus
- University Hospital of Ioannina — Ioannina, Epirus, Greece (Recruiting)
Study contacts
- Study coordinator: Agathi Karakosta
- Email: akarakosta@uoi.gr
- Phone: +306948066243
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.