Improving pain management and recovery after cesarean delivery
Quality of Postoperative Analgesia and Functional Recovery After Elective Cesarean Delivery Adding Different Doses of Intrathecal Fentanyl to Spinal Anesthesia With Bupivacaine and Intrathecal Morphine. A Single Center, Randomized, Multiple Blinded, Controlled Trial
This study tests if adding fentanyl to spinal anesthesia helps women have less pain and recover better after a cesarean delivery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 63 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Ente Ospedaliero Cantonale, Bellinzona Academic / other |
| Locations | 1 site (Bellinzona) |
| Trial ID | NCT06355271 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of different doses of fentanyl combined with spinal anesthesia for patients undergoing elective cesarean deliveries. Participants will be randomly assigned to receive either a standard spinal anesthesia or one with an added dose of fentanyl. The study will monitor postoperative pain levels and functional recovery over a 24-hour period following surgery. The aim is to determine if the addition of fentanyl improves analgesia and recovery outcomes compared to the standard treatment.
Who should consider this trial
Good fit: Ideal candidates are adult women over 18 years old, scheduled for elective cesarean delivery, and in good health (ASA physical status I or II).
Not a fit: Patients who may not benefit include those with contraindications to spinal anesthesia, such as hemodynamic instability or infections at the surgery site.
Why it matters
Potential benefit: If successful, this study could lead to enhanced pain management and quicker recovery for patients after cesarean deliveries.
How similar studies have performed: Previous studies have shown promising results with the use of fentanyl in spinal anesthesia for postoperative pain management, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients over 18 year of age * height over 160 cm * American Society Anesthesiologists physical status I and II * term singleton parturients * scheduled for elective cesarean delivery during spinal anesthesia at Ospedale Regionale Bellinzona Valli Exclusion Criteria: * patients with inability to consent * patient refusal * contraindication to spinal anesthesia (eg, hemodynamic instability, infection at the surgery site, and neurologic defects such as transverse myelitis) * emergency cesarean delivery * preeclampsia/eclampsia * allergy to drugs used in the protocol
Where this trial is running
Bellinzona
- Ospedale Regionale di Bellinzona, San Giovanni — Bellinzona, Switzerland (Recruiting)
Study contacts
- Study coordinator: Roberto Dossi
- Email: roberto.dossi@eoc.ch
- Phone: 0918119341
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.