Analgesic Efficacy of Intrathecal Fentanyl-Morphine Combination Versus Morphine Alone for Intraoperative Pain During Elective Cesarean Delivery: a Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 186
- 主要终点
- Incidence of intraoperative pain
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 99 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Parturients of gestational age > 37 weeks, scheduled for cesarean section under spinal anesthesia
排除标准
- •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
研究组 & 干预措施
Fentanyl-Morphine
Spinal anesthesia with heavy bupivacaine, fentanyl and morphine
干预措施: Fentanyl-Morphine (Drug)
Morphine
Spinal anesthesia with heavy bupivacaine and morphine
干预措施: Morphine (Drug)
结局指标
主要结局
Incidence of intraoperative pain
时间窗: From first skin incision to end of surgery
Incidence of intraoperative pain of NRS (numeric rating scale) score of 4 or higher
次要结局
- 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)
研究者
Jin-Tae Kim
Professor
Seoul National University Hospital