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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age19-99
SponsorSeoul National University Hospital

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Fentanyl-Morphine

    Drug

    Intrathecal injection of bupivacaine, fentanyl and morphine

  • Morphine

    Drug

    Intrathecal injection of bupivacaine and morphine

Treatment groups

186 Participants
are divided into 2 treatment groups
Group A: Fentanyl-MorphineExperimental treatment 1 intervention
Group B: MorphineActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Incidence of intraoperative pain

Incidence of intraoperative pain of NRS (numeric rating scale) score of 4 or higher

Time frame
From first skin incision to end of surgery

Secondary outcomes

1

Time of occurence of intraoperative pain

Time of occurence of intraoperative pain of NRS (numeric rating scale) score of 4 or higher

Time frame
From first skin incision to end of surgery
2

Incidence of intraoperative rescue analgesic administration

Incidence of intraoperative rescue analgesic administration

Time frame
From first skin incision to end of surgery
3

Total amount of intraoperative opioid rescue analgesic administration

Total amount of intraoperative opioid rescue analgesic administration (morphine mg equivalent)

Time frame
From first skin incision to end of surgery
4

Total amount of intraoperative non-opioid rescue analgesic administration

Total amount of intraoperative non-opioid rescue analgesic administration (mg)

Time frame
From first skin incision to end of surgery

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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