About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Parturients of gestational age > 37 weeks, scheduled for cesarean section under spinal anesthesia
Disqualifiers
Contraindication to spinal anesthesia
Any sign of onset of labor
Emergency cesarean section
Body weight < 40 kg or > 120 kg
Trial design
Parallel
Treatments tested in this trial
Fentanyl-Morphine
DrugIntrathecal injection of bupivacaine, fentanyl and morphine
Morphine
DrugIntrathecal injection of bupivacaine and morphine
Treatment groups
Trial outcomes
Primary outcomes
Incidence of intraoperative pain
Incidence of intraoperative pain of NRS (numeric rating scale) score of 4 or higher
Secondary outcomes
Time of occurence of intraoperative pain
Time of occurence of intraoperative pain of NRS (numeric rating scale) score of 4 or higher
Incidence of intraoperative rescue analgesic administration
Incidence of intraoperative rescue analgesic administration
Total amount of intraoperative opioid rescue analgesic administration
Total amount of intraoperative opioid rescue analgesic administration (morphine mg equivalent)
Total amount of intraoperative non-opioid rescue analgesic administration
Total amount of intraoperative non-opioid rescue analgesic administration (mg)
Locations
Sponsors and contacts
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