Analgesic Efficacy of Intrathecal Fentanyl-Morphine Combination Versus Morphine Alone for Intraoperative Pain During Elective Cesarean Delivery
NCT Number: NCT06570343
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE4
Conditions: Intraoperative Pain
Interventions: DRUG: Fentanyl-Morphine|DRUG: Morphine
Sponsor: Seoul National University Hospital
Sex: FEMALE
Age: ADULT, OLDER_ADULT
Enrollment: 186
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2024-09-20
Completion Date: 2025-12-25

Summary:
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.

Primary Outcome Measures: Incidence of intraoperative pain, Incidence of intraoperative pain of NRS (numeric rating scale) score of 4 or higher, From first skin incision to end of surgery
Secondary Outcome Measures: Time of occurence of intraoperative pain, Time of occurence of intraoperative pain of NRS (numeric rating scale) score of 4 or higher, From first skin incision to end of surgery|Incidence of intraoperative rescue analgesic administration, Incidence of intraoperative rescue analgesic administration, 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), 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), From first skin incision to end of surgery|Intraoperative pain characteristics, Intraoperative pain characteristics, From first skin incision to end of surgery|Conversion to general anesthesia, Conversion to general anesthesia, From first skin incision to end of surgery|Preoperative anxiety, Preoperative anxiety (APAIS, Amsterdam Preoperative Anxiety and Information Score), On the day before surgery|Preoperative anxiety, Preoperative anxiety (APAIS, Amsterdam Preoperative Anxiety and Information Score), On the day of surgery|Total amount of postoperative opioid analgesic administered, Total amount of postoperative opioid analgesic administered (morphine mg equivalent), From end of surgery to 24 hours after end of surgery|Obstetric Quality of Recovery-11K score, Obstetric Quality of Recovery-11K score, At 24h post-surgery|Time of first postoperative pain, Time of first postoperative pain, From end of surgery to 24h post-surgery|Pain score at 2h post-surgery, Pain score at 2h post-surgery (NRS, numeric rating scale pain score, 0: no pain; 10: worst imaginable pain), at 2h post-surgery|Pain score at 8h post-surgery, Pain score at 8h post-surgery (NRS, numeric rating scale pain score, 0: no pain; 10: worst imaginable pain), at 8h post-surgery|Pain score at 16h post-surgery, Pain score at 16h post-surgery (NRS, numeric rating scale pain score, 0: no pain; 10: worst imaginable pain), at 16h post-surgery|Pain score at 24h post-surgery, Pain score at 24h post-surgery (NRS, numeric rating scale pain score, 0: no pain; 10: worst imaginable pain), at 24h post-surgery|Incidence of intraoperative nausea/vomiting, Incidence of intraoperative nausea/vomiting, From induction to end of surgery|Incidence of postoperative nausea/vomiting, Incidence of postoperative nausea/vomiting, From end of surgery to 24h post-surgery|Incidence of intraoperative shivering, Incidence of intraoperative shivering, From induction to end of surgery|Incidence of postoperative shivering, Incidence of postoperative shivering, From end of surgery to 24h post-surgery|Incidence of intraoperative hypotension, Incidence of intraoperative hypotension (MBP\<65 mmHg), From induction to end of surgery|Incidence of postoperative hypotension, Incidence of postoperative hypotension (MBP\<65 mmHg), From end of surgery to 24h post-surgery|Incidence of intraoperative pruritus, Incidence of intraoperative pruritus, From induction to end of surgery|Incidence of postoperative pruritus, Incidence of postoperative pruritus, From end of surgery to 24h post-surgery|Immediate post-operative patient satisfaction, Immediate post-operative patient satisfaction on intraoperative analgesia, At the end of surgery|24h post-operative patient satisfaction, 24h post-operative patient satisfaction on postoperative analgesia, at 24h post-surgery