Intrathecal Versus Epidural Morphine for Post-Cesarean Analgesia: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Postoperative pain control
研究概览
简要总结
Cesarean section is one of the most commonly performed surgical procedures worldwide, making effective management of acute postoperative pain a key issue in obstetric anesthesiology. Post-cesarean analgesia should promote rapid maternal recovery, support newborn care, and consider the pharmacological implications for breastfeeding.
According to recent PROSPECT® guidelines from ESRA, neuraxial opioids play a central role in post-cesarean analgesia and are at least as effective as other techniques, such as continuous local anesthetic infusion. However, the optimal route of opioid administration remains unclear. While earlier studies favored epidural morphine, more recent evidence suggests that intrathecal morphine may provide superior analgesia. Due to limited and conflicting data, no definitive conclusion can be drawn. Given that epidural morphine remains standard practice at Hospital Central do Funchal, a randomized clinical trial is proposed to compare the analgesic efficacy of intrathecal versus epidural morphine after elective cesarean section.
详细描述
This unicentric randomized clinical trial aims to determine whether intrathecal morphine provides superior postoperative analgesia compared with epidural morphine during the first 24 hours following cesarean section. The study population will consist of pregnant women undergoing elective cesarean delivery at Hospital Central do Funchal.
Participants will be randomly assigned to one of two groups. One group will receive postoperative analgesia with intrathecal morphine (80 mcg). The second group will receive epidural morphine, administered as a 2.5 mg bolus at the end of surgery, followed by an additional 2.5 mg bolus 24 hours postoperatively.
The primary outcome will be the assessment of pain during the first 24 postoperative hours. Secondary outcomes will include pain assessment during the first 48 hours, the need for rescue analgesia, levels of sedation, incidence of nausea and vomiting, pruritus, the impact of pain on mobilization and other activities, and overall maternal satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Pregnant women scheduled for elective cesarean section;
- •Age > 18 years;
- •Willingness to participate in the study, as demonstrated by signed informed consent.
排除标准
- •American Society of Anesthesiologists (ASA) physical status classification > III;
- •Chronic kidney disease with a glomerular filtration rate < 60 mL/min;
- •Relevant drug allergies (particularly to protocol medications);
- •Opioid tolerance;
- •Contraindication to neuraxial anesthetic techniques.
研究组 & 干预措施
Intrathecal morphine
Postoperative analgesia with intrathecal morphine 80 mcg
干预措施: Intrathecal Morphine (Drug)
Epidural morphine
Postoperative analgesia with epidural morphine 2.5mg
干预措施: Epidural Morphine (Drug)
结局指标
主要结局
Postoperative pain control
时间窗: Evaluation at 24 hours after surgery
Comparison between intrathecal morphine versus epidural morphine analgesia assessed using the Numeric Rating Scale (NRS) as part of the PAIN OUT questionnaire.
次要结局
- Total rescue opioid consumption(Evaluation at 24 hours and 48 hours after surgery)
- Adverse effects associated with analgesia(Evaluation at 24 hours and 48 hours after surgery)
- Patients satisfaction with analgesia(Evaluation at 24 hours and 48 hours after surgery)
- Postoperative pain control(Evaluation at 48 hours after surgery)
研究者
Joao Salgado Costa
Anesthesiology Resident
Hospital Central do Funchal