An interventional study of fentanyl and morphine in Cesarean Section, sponsored by Seoul National University Hospital. Completed at 1 site in Korea, Republic of. Open to female participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2022-02-24.
Sponsored by Seoul National University Hospital · Not applicable, Interventional, and Treatment
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.
Seoul National University Hospital is the lead sponsor of 1,860 studies on the registry; 275 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will receive spinal anesthesia with 0.5% bupivacaine 9 mg + fentanyl 10 mcg. Following the completion of surgery, ultrasound-guided bilateral transversus abdominis plane block will be done with 0.375% ropivacaine 15 ml per each side.
Drug: fentanyl · Procedure: Transversus abdominis plane block
Patients will receive spinal anesthesia with 0.5% bupivacaine 9 mg + morphine 75 mcg. Following the completion of surgery, sham block will be done using normal saline.
Drug: morphine · Procedure: Sham block
Fentanyl 10 mcg will be injected intrathecally during spinal anesthesia.
Morphine 75 mcg will be injected intrathecally during spinal anesthesia.
Also known as: Morphine sulfate
Ultrasound-guided bilateral transversus abdominis plane block will be done. 0.375% ropivacaine 15 ml per side will be injected.
Ultrasound-guided bilateral transversus abdominis plane sham block will be done. Normal saline 15 ml per side will be injected.
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
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
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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Seoul National University Hospital