Analgesic Efficacy of Intrathecal Fentanyl-Morphine Combination Versus Morphine Alone for Intraoperative Pain During Elective Cesarean Delivery: a Randomized Clinical Trial
Overview
- Phase
- Phase 4
- Intervention
- Fentanyl-Morphine
- Conditions
- Intraoperative Pain
- Sponsor
- Seoul National University Hospital
- Enrollment
- 186
- Primary Endpoint
- Incidence of intraoperative pain
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
Brief 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.
Investigators
Jin-Tae Kim
Professor
Seoul National University Hospital
Eligibility Criteria
Inclusion Criteria
- •Parturients of gestational age \> 37 weeks, scheduled for cesarean section under spinal anesthesia
Exclusion Criteria
- •Contraindication to spinal anesthesia
- •Any sign of onset of labor
- •Emergency cesarean section
- •Body weight \< 40 kg or \> 120 kg
- •Height \< 140 cm or \> 190 cm
- •Severe underlying cardiovascular disease
- •Known fetal anomaly
- •Preeclampsia
- •History of hypersensitivity to fentanyl or morphine
- •Chronic opioid use
Arms & Interventions
Fentanyl-Morphine
Spinal anesthesia with heavy bupivacaine, fentanyl and morphine
Intervention: Fentanyl-Morphine
Morphine
Spinal anesthesia with heavy bupivacaine and morphine
Intervention: Morphine
Outcomes
Primary Outcomes
Incidence of intraoperative pain
Time Frame: From first skin incision to end of surgery
Incidence of intraoperative pain of NRS (numeric rating scale) score of 4 or higher
Secondary Outcomes
- Time of occurence of intraoperative pain(From first skin incision to end of surgery)
- Incidence of intraoperative rescue analgesic administration(From first skin incision to end of surgery)
- Incidence of postoperative hypotension(From end of surgery to 24 hours post-surgery)
- Incidence of postoperative shivering(From end of surgery to 24 hours post-surgery)
- 24-hour post-operative patient satisfaction(at 24 hours post-surgery)
- Total amount of intraoperative opioid rescue analgesic administration(From first skin incision to end of surgery)
- Total amount of intraoperative non-opioid rescue analgesic administration(From first skin incision to end of surgery)
- Intraoperative pain characteristics(From first skin incision to end of surgery)
- Conversion to general anesthesia(From first skin incision to end of surgery)
- Preoperative anxiety(On the day of surgery)
- Total amount of postoperative opioid analgesic administered(From end of surgery to 24 hours after end of surgery)
- Incidence of intraoperative nausea/vomiting(From induction to end of surgery)
- Incidence of postoperative nausea/vomiting(From end of surgery to 24h post-surgery)
- Incidence of intraoperative shivering(From induction to end of surgery)
- Incidence of intraoperative hypotension(From induction to end of surgery)
- Incidence of intraoperative pruritus(From induction to end of surgery)
- Incidence of postoperative pruritus(From end of surgery to 24h post-surgery)
- Immediate post-operative patient satisfaction(At the end of surgery)
- Obstetric Quality of Recovery-11K score(At 24 hours post-surgery)
- Time of first postoperative pain(From end of surgery to 24 hours post-surgery)
- Pain score at 8 hours post-surgery(at 8 hours post-surgery)
- Pain score at 16 hours post-surgery(at 16 hours post-surgery)
- Pain score at 24 hours post-surgery(at 24 hours post-surgery)
- Pain score at 2 hours post-surgery(at 2 hours post-surgery)