Status:
ACTIVE_NOT_RECRUITING
Pain Control and Side Effects in Cesarean Section Anesthesia: Comparison of Intrathecal Morphine and Fentanyl
Lead Sponsor:
University of Oradea
Collaborating Sponsors:
Oradea Pelican Clinic Hospital
Conditions:
Anaesthesia, Spinal
Eligibility:
FEMALE
18-50 years
Brief Summary
Intrathecal opioids are frequently combined with local anesthetics to optimize spinal anesthesia for cesarean delivery. Fentanyl, a lipophilic opioid, offers rapid onset and enhanced intraoperative an...
Detailed Description
Eligible patients will be allocated in a 1:1 ratio into one of two groups: Group F (Fentanyl): Hyperbaric bupivacaine 0.5% combined with fentanyl 25 µg. Group M+F (Morphine + Fentanyl): Hyperbaric bu...
Eligibility Criteria
Inclusion
- American Society of Anesthesiologists (ASA) physical status class I-II.
- Absence of significant past medical conditions.
- No documented hypersensitivity to any study drug.
- No history of chronic pain syndromes or regular analgesic consumption.
- No anxiety or depressive disorders diagnosis.
- Body weight ≥ 50 kg.
- Scheduled for elective cesarean delivery.
- Single fetus.
Exclusion
- Patient refusal.
- Contraindication of spinal anaesthesia.
- Conversion from a natural delivery with or without an epidural anaesthesia started.
- History of substance abuse or drug dependence.
- Presence of acute or chronic fetal distress.
- Preeclampsia.
- Allergic reaction occurring after enrollment.
- Refusal to receive protocol-specified analgesics or medications.
- Requirement for surgical re-intervention within 72 hours postoperatively.
- Previous administration of opioids or other central nervous system depressants prior to intervention.
Key Trial Info
Start Date :
August 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT07144410
Start Date
August 1 2025
End Date
October 1 2025
Last Update
August 27 2025
Active Locations (1)
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1
University of Oradea, Pelican Clinic Hospital
Oradea, Bihor County, Romania, 410505