A Phase 4 interventional study of Fentanyl-Morphine and Morphine in Intraoperative Pain, sponsored by Seoul National University Hospital. Not yet recruiting. Open to female participants aged 19 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-01.
Sponsored by Seoul National University Hospital · Phase 4, Interventional, and Prevention
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.
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:
Spinal anesthesia with heavy bupivacaine, fentanyl and morphine
Drug: Fentanyl-Morphine
Spinal anesthesia with heavy bupivacaine and morphine
Drug: Morphine
Intrathecal injection of bupivacaine, fentanyl and morphine
Intrathecal injection of bupivacaine and morphine
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
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
Incidence of intraoperative rescue analgesic administration
Incidence of intraoperative rescue analgesic administration
Time frame: From first skin incision to end of surgery
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
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
Intraoperative pain characteristics
Intraoperative pain characteristics
Time frame: From first skin incision to end of surgery
Conversion to general anesthesia
Conversion to general anesthesia
Time frame: From first skin incision to end of surgery
Preoperative anxiety
Preoperative anxiety (APAIS, Amsterdam Preoperative Anxiety and Information Score)
Time frame: On the day before surgery
Preoperative anxiety
Preoperative anxiety (APAIS, Amsterdam Preoperative Anxiety and Information Score)
Time frame: On the day of surgery
Total amount of postoperative opioid analgesic administered
Total amount of postoperative opioid analgesic administered (morphine mg equivalent)
Time frame: From end of surgery to 24 hours after end of surgery
Incidence of intraoperative nausea/vomiting
Incidence of intraoperative nausea/vomiting
Time frame: From induction to end of surgery
Incidence of postoperative nausea/vomiting
Incidence of postoperative nausea/vomiting
Time frame: From end of surgery to 24h post-surgery
Incidence of intraoperative shivering
Incidence of intraoperative shivering
Time frame: From induction to end of surgery
Incidence of intraoperative hypotension
Incidence of intraoperative hypotension (MBP\<65 mmHg)
Time frame: From induction to end of surgery
Incidence of intraoperative pruritus
Incidence of intraoperative pruritus
Time frame: From induction to end of surgery
Incidence of postoperative pruritus
Incidence of postoperative pruritus
Time frame: From end of surgery to 24h post-surgery
Immediate post-operative patient satisfaction
Immediate post-operative patient satisfaction on intraoperative analgesia
Time frame: At the end of surgery
Obstetric Quality of Recovery-11K score
Obstetric Quality of Recovery-11K score
Time frame: At 24 hours post-surgery
Time of first postoperative pain
Time of first postoperative pain
Time frame: From end of surgery to 24 hours post-surgery
Pain score at 8 hours post-surgery
Pain score at 8 hours post-surgery (NRS, numeric rating scale pain score, 0: no pain; 10: worst imaginable pain)
Time frame: at 8 hours post-surgery
Pain score at 16 hours post-surgery
Pain score at 16 hours post-surgery (NRS, numeric rating scale pain score, 0: no pain; 10: worst imaginable pain)
Time frame: at 16 hours post-surgery
Pain score at 24 hours post-surgery
Pain score at 24 hours post-surgery (NRS, numeric rating scale pain score, 0: no pain; 10: worst imaginable pain)
Time frame: at 24 hours post-surgery
Pain score at 2 hours post-surgery
Pain score at 2 hours post-surgery (NRS, numeric rating scale pain score, 0: no pain; 10: worst imaginable pain)
Time frame: at 2 hours post-surgery
Incidence of postoperative hypotension
Incidence of postoperative hypotension (MBP\<65 mmHg)
Time frame: From end of surgery to 24 hours post-surgery
Incidence of postoperative shivering
Incidence of postoperative shivering
Time frame: From end of surgery to 24 hours post-surgery
24-hour post-operative patient satisfaction
24-hour post-operative patient satisfaction on postoperative analgesia
Time frame: at 24 hours post-surgery
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
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Seoul National University Hospital