Analgesic Efficacy of Intrathecal Fentanyl-Morphine Combination Versus Morphine Alone for Intraoperative Pain During Elective Cesarean Delivery
Phase 4
Not yet recruiting
- Conditions
- Intraoperative Pain
- Registration Number
- NCT06570343
- Lead Sponsor
- Seoul National University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not yet recruiting
- Sex
- Female
- Target Recruitment
- 186
Inclusion Criteria
Inclusion Criteria:<br><br> - Parturients of gestational age > 37 weeks, scheduled for cesarean section under<br> spinal anesthesia<br><br>Exclusion Criteria:<br><br> - Contraindication to spinal anesthesia<br><br> - Any sign of onset of labor<br><br> - Emergency cesarean section<br><br> - Body weight < 40 kg or > 120 kg<br><br> - Height < 140 cm or > 190 cm<br><br> - Severe underlying cardiovascular disease<br><br> - Known fetal anomaly<br><br> - Preeclampsia<br><br> - History of hypersensitivity to fentanyl or morphine<br><br> - Chronic opioid use
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of intraoperative pain
- Secondary Outcome Measures
Name Time Method Time of occurence of intraoperative pain;Incidence of intraoperative rescue analgesic administration;Total amount of intraoperative opioid rescue analgesic administration;Total amount of intraoperative non-opioid rescue analgesic administration;Intraoperative pain characteristics;Conversion to general anesthesia;Preoperative anxiety;Preoperative anxiety;Total amount of postoperative opioid analgesic administered;Obstetric Quality of Recovery-11K score;Time of first postoperative pain;Pain score at 2h post-surgery;Pain score at 8h post-surgery;Pain score at 16h post-surgery;Pain score at 24h post-surgery;Incidence of intraoperative nausea/vomiting;Incidence of postoperative nausea/vomiting;Incidence of intraoperative shivering;Incidence of postoperative shivering;Incidence of intraoperative hypotension;Incidence of postoperative hypotension;Incidence of intraoperative pruritus;Incidence of postoperative pruritus;Immediate post-operative patient satisfaction;24h post-operative patient satisfaction