Epidural Esketamine and Morphine for Postoperative Analgesia After Caesarean Delivery: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 119
- 试验地点
- 1
- 主要终点
- Postoperative pain score at rest
研究概览
简要总结
The aim of this study was to determine whether the addition of esketamine to morphine would improve postoperative analgesia after caesarean section.
Parturients who planned for a caesarean delivery using combined spinal-epidural anaesthesia with a request for postoperative anaesthesia were randomly divided into four groups (A, B, C and D). When the surgery was completed, the parturients in groups A, B, C and D were administered 2 mg morphine, 0.25mg/kg of esketamine, 0.25mg/kg of esketamine plus 2 mg morphine sulfate and 0.25mg/kg of esketamine plus 1 mg morphine through the epidural catheters, respectively. The postoperative pain at rest, pain with movement, the number of rescue analgesics and adverse effects were evaluated for 48 h after caesarean delivery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 32 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •nulliparous parturients who scheduled for elective caesarean delivery under spinal-epidural anaesthesia;
- •parturients who had requested postoperative analgesia;
- •parturients aged between 20-35 years old;
- •parturients who had a full-term pregnancy;
- •parturients who were identified as having a singleton pregnancy; and
- •parturients who were categorised as having an American Society of Anaesthesiologists (ASA) physical status
排除标准
- •parturients with severe internal, surgical or obstetric comorbidities (including spinal deformities, hypertension, placental abruption, cholestasis in pregnancy, asthma, heart disease and abnormal coagulation parameters)
- •parturients with a known allergy to the drugs used in this study
- •parturients with severe mental illness who could not comply with doctors' instructions
- •parturients with chronic pain syndrome, which is defined as pain that persists for a period longer than 3 months
研究组 & 干预措施
group D
The parturients in group D were administered 0.25mg/kg of esketamine in combination with 1 mg morphine sulfate.
干预措施: 0.25mg/kg of esketamine in combination with 1 mg morphine sulfate (Drug)
group A
The parturients in group A were administered 2 mg morphine sulfate through the epidural catheter.
干预措施: 2 mg morphine sulfate (Drug)
group B
The parturients in group B were administered 0.25mg/kg of esketamine.
干预措施: 0.25mg/kg esketamine (Drug)
group C
The parturients in group C were administered 0.25mg/kg of esketamine in combination with 2 mg morphine sulfate.
干预措施: 0.25mg/kg of esketamine in combination with 2 mg morphine sulfate (Drug)
结局指标
主要结局
Postoperative pain score at rest
时间窗: Forty-eight hours after caesarean delivery
The pain scores at rest were evaluated by the parturients themselves using a VAS based on a linear scale from 0 to 10, where 0 represented an absence of pain and 10 represented maximal pain.
Postoperative pain score with movement
时间窗: Forty-eight hours after caesarean delivery
The pain scores on movement were evaluated by the parturients themselves using a VAS based on a linear scale from 0 to 10, where 0 represented an absence of pain and 10 represented maximal pain.
number of rescue analgesics required
时间窗: within Forty-eight hours of surgery
The number of rescue analgesics required within 48 h of surgery was recorded
次要结局
- heart rate (HR)(Forty-eight hours after caesarean delivery)
- Blood oxygen saturation (SpO2)(Forty-eight hours after caesarean delivery)
- systolic blood pressure (SBP)(Forty-eight hours after caesarean delivery)
- diastolic blood pressure (DBP)(Forty-eight hours after caesarean delivery)
- Adverse events(within Forty-eight hours of surgery)