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

Seoul National University

Status and phase: Not yet enrolling; Phase 4

Conditions: Intraoperative Pain

Treatments: Drug: Fentanyl-Morphine; Drug: Morphine

Study type: Interventional

Funder types: Other

Identifiers

NCT06570343

2407-091-1553

Details and patient eligibility

About

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.

Enrollment: 186 estimated patients

Sex: Female

Ages: 19 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Parturients of gestational age > 37 weeks, scheduled for cesarean section under spinal anesthesia

Exclusion criteria

• Contraindication to spinal anesthesia
• Any sign of onset of labor
• Emergency cesarean section
• Body weight < 40 kg or > 120 kg
• Height < 140 cm or > 190 cm
• Severe underlying cardiovascular disease
• Known fetal anomaly
• Preeclampsia
• History of hypersensitivity to fentanyl or morphine
• Chronic opioid use

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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186 participants in 2 patient groups

Fentanyl-Morphine

Experimental group

Description:

Spinal anesthesia with heavy bupivacaine, fentanyl and morphine

Treatment:

Drug: Fentanyl-Morphine

Morphine

Active Comparator group

Description:

Spinal anesthesia with heavy bupivacaine and morphine

Treatment:

Drug: Morphine