This noninferiority study aims to determine whether transversus abdominis plane (TAP) block with intrathecal fentanyl could provide a noninferior analgesia compared with intrathecal morphine after cesarean delivery under spinal anesthesia.
Healthy mothers scheduled to undergo elective cesarean delivery under spinal anesthesia will be randomly allocated to receive either TAP block plus intrathecal fentanyl (Group TF) or intrathecal morphine (Group M). Primary outcome is pain score with movement at postoperative 24 hours.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
Fentanyl 10 mcg will be injected intrathecally during spinal anesthesia.
Morphine 75 mcg will be injected intrathecally during spinal anesthesia.
Ultrasound-guided bilateral transversus abdominis plane block will be done. 0.375% ropivacaine 15 ml per side will be injected.
Jin-Tae Kim
Seoul, South Korea
Pain score with movement at 24 hours after delivery
Pain score with movement at 24hr after delivery, using 11-point Numeric rating scale (0, no pain; 10, the worst pain imaginable)
Time frame: at 24 hours after delivery
Intravenous fentanyl consumption
cumulative fentanyl consumption via intravenous patient-controlled analgesia
Time frame: at 6, 12, 18, 24, 48 hours after delivery
Pain score at rest
Pain score at rest using 11-point Numeric rating scale (0, no pain; 10, the worst pain imaginable)
Time frame: at 6, 12, 18, 24, 48 hours after delivery
Pain score with movement
Pain score with movement using 11-point Numeric rating scale (0, no pain; 10, the worst pain imaginable)
Time frame: at 6, 12, 18, 48 hours after delivery
time to first opioid request
time to first intravenous fentanyl administration from delivery
Time frame: during hospital stay, an average of 3 days
number of patients requiring rescue analgesics
number of patients requiring rescue analgesics
Time frame: During the first 48 hour-period after delivery
Incidence of nausea
Proportion of patients who experienced nausea
Time frame: During the first 48 hour-period after delivery
Incidence of vomiting
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Ultrasound-guided bilateral transversus abdominis plane sham block will be done. Normal saline 15 ml per side will be injected.
Proportion of patients who experienced vomiting
Time frame: During the first 48 hour-period after delivery
Incidence of pruritus
Proportion of patients who experienced pruritus
Time frame: During the first 48 hour-period after delivery
Incidence of sedation
Proportion of patients who experienced sedation
Time frame: During the first 48 hour-period after delivery
Incidence of respiratory depression
Proportion of patients who experienced respiratory depression
Time frame: During the first 48 hour-period after delivery
Nausea severity
Nausea severity using 4-point scale with 0=none, 1=mild, 2=moderate, or 3=severe
Time frame: During the first 48 hour-period after delivery
Pruritus severity
Pruritus severity using 4-point scale with 0=none, 1=mild, 2=moderate, or 3=severe
Time frame: During the first 48 hour-period after delivery
Patient satisfaction for overall postoperative managements using 11-point scale (0=totally unsatisfied; 10=totally satisfied)
Patient satisfaction score for overall postoperative pain managements using 11-point scale (0=totally unsatisfied; 10=totally satisfied)
Time frame: During the first 48 hour-period after delivery
Hospital length of stay
Hospital length of stay (day)
Time frame: From admission to hospital discharge, an average of 3 days
Apgar Score
Apgar Score of fetus
Time frame: at 1 minute, at 5 minutes
Umbilical arterial pH
Umbilical arterial pH
Time frame: immediately after delivery
Umbilical arterial PO2
Umbilical arterial PO2
Time frame: immediately after delivery
Umbilical arterial PCO2
Umbilical arterial PCO2
Time frame: immediately after delivery