Clinical Trial

Pain Control and Side Effects in Cesarean Section Anesthesia: Comparison of Intrathecal Morphine and Fentanyl

Study acronym: FvMinSACS
Active, Not Recruiting
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Record status
This record was last updated August 27, 2025 (before its estimated October 2025 completion). Its status may not reflect the trial's current state.
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 analgesia. However, its postoperative analgesic duration is limited, but in contrast, morphine, a hydrophilic opioid, provides prolonged postoperative pain control but has a slower onset and a higher incidence of adverse effects, notably nausea and vomiting. This prospective, randomized, double-blind, parallel study enrolled 180 parturients scheduled for elective cesarean section, all receiving spinal anesthesia with hyperbaric bupivacaine (7.5-10 mg, adjusted to height) plus either intrathecal fentanyl 25 µg (F group) or intrathecal morphine 100 µg and fentanyl 25µg (M+F group). Primary outcomes include intraoperative and postoperative pain scores, systemic opioid consumption, and patient satisfaction, while secondary outcomes assess the incidence of opioid-related side effects.
Trial Details
NCT Number NCT07144410
Lead Sponsor University of Oradea
Collaborators: Oradea Pelican Clinic Hospital
Conditions Anaesthesia, Spinal
Enrollment 180 participants
Start Date 2025-08-01
Primary Completion 2025-10 (estimated)
Study Completion 2025-10 (estimated)
Updated on ClinicalTrials.gov 2025-08-27