Clinical Trial

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

Not Yet Recruiting Phase 4
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Record status
This record was last updated October 1, 2024 (before its estimated September 20, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-08-22.
Trial Details
NCT Number NCT06570343
Lead Sponsor Seoul National University Hospital
Conditions Intraoperative Pain
Enrollment 186 participants
Start Date 2024-09-20
Primary Completion 2025-09-20 (estimated)
Study Completion 2025-12-25 (estimated)
Updated on ClinicalTrials.gov 2024-10-01