drugset
drugset / Trial / NCT06570343

Analgesic Efficacy of Intrathecal Fentanyl-Morphine Combination Versus Morphine Alone for Intraoperative Pain During Elective Cesarean Delivery

NCT06570343 ↗

Phase 4 Not yet recruiting 186 enrolled Seoul National University Hospital
RandomizedParallel-groupTriple-blindPrevention

Summary

Pregnant women scheduled for elective cesarean sections under spinal anesthesia are randomly assigned to two groups: 1) the Fentanyl-Morphine (FM) group, and 2) the Morphine (M) group. In addition to 11.5 mg of bupivacaine, the FM group receives 15 μg of fentanyl and 50 μg of morphine intrathecally, while the M group receives 50 μg of morphine intrathecally. The incidence of intraoperative pain with a Numerical Rating Scale (NRS) score of 4 or higher is compared between the two groups to evaluate the analgesic effects of combined intrathecal fentanyl-morphine therapy versus morphine alone.

Timeline

Start
2024-09-20
Primary completion
2025-09-20
Completion
2025-12-25

Drugs

EvaluationDrugModalityDoseRoute
Subject Fentanyl Other / unclassified 15 ug Intrathecal
Comparator Morphine Other / unclassified 50 ug Intrathecal
Background Bupivacaine Other / unclassified 11.5 mg Intrathecal

Indications

No indication recorded.