NCT06570343

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

Analgesic Efficacy of Intrathecal Fentanyl-Morphine Combination Versus Morphine Alone for Intraoperative Pain During Elective Cesarean Delivery: a Randomized Clinical Trial

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 186 (estimated)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: Female
• Age: 19 Years – 99 Years
• Healthy volunteers: Accepted

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.

Conditions

• Intraoperative Pain

Interventions

Type	Name	Description
DRUG	Fentanyl-Morphine	Intrathecal injection of bupivacaine, fentanyl and morphine
DRUG	Morphine	Intrathecal injection of bupivacaine and morphine

Timeline

• Start date: 2024-09-20
• Primary completion: 2025-09-20
• Completion: 2025-12-25
• First posted: 2024-08-26
• Last updated: 2024-10-01