Effect of S-ketamine in Cesarean Section Combined Anesthesia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Maximum pain score (NRS socre) at 0-24 hours postoperatively
研究概览
简要总结
To compare the anti-hyperalgesia effect between S-ketamine with placebo for Maternal receiving elective Cesarean Section under Combined spinal and epidural analgesia.
Based on this study the investigators intend to verify the role and potential mechanism of S-ketamine combined anesthesia in alleviating hyperalgesia after cesarean section, prove that it can reduce hyperalgesia and postoperative pain. explore the role of S-ketamine in alleviating postoperative hyperalgesia in different PCA ways and explore the safety of S-ketamine in the perilactation
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •ASA status I-III
- •Age 20 to 45
- •37-42 weeks gestation
- •undergo elective cesarean section with subarachnoid anesthesia
- •participate in this study and sign informed consent
排除标准
- •Patients with contraindications for cesarean section
- •Patients with contraindications of combined spinal and epidural anesthesia
- •Patients with severe systemic disease
- •Alcoholism and long-term use of anti-inflammatory and analgesic drugs
- •Patients who were unable to cooperate or refused to participate in the trial
- •Patients with contraindications to esketamine and hydromorphone
研究组 & 干预措施
Group E1
S-ketamine was administered intravenously after delivery，patient controlled epidural analgesia（PCEA）was administered postoperatively PCEA formula：（10μg/ml hydromorphone+0.11% ropivacaine) 200ml
干预措施: S-ketamine (Drug)
Group E2
S-ketamine was administered intravenously after delivery，patient controlled intravenous analgesia（PCIA) was administered postoperatively PCIA formula：（100μg/ml hydromorphone) 100ml
干预措施: S-ketamine (Drug)
Group C1
placebo was administered intravenously after delivery，patient controlled epidural analgesia（PCEA) was administered postoperatively PCEA formula：（10μg/ml hydromorphone+0.11% ropivacaine) 200ml
干预措施: S-ketamine (Drug)
Group C2
placebo was administered intravenously after delivery，patient controlled intravenous analgesia（PCIA） was administered postoperatively PCIA formula：（100μg/ml hydromorphone) 100ml
干预措施: S-ketamine (Drug)
结局指标
主要结局
Maximum pain score (NRS socre) at 0-24 hours postoperatively
时间窗: From ending of the surgery to 24 hours postoperatively
NRS score: Pain was assessed on a scale of 0-10, with 0 being no pain and 10 being most painful
Pain score (NRS socre) at 0-6 hours postoperatively
时间窗: From ending of the surgery to 6 hours postoperatively
NRS score: Pain was assessed on a scale of 0-10, with 0 being no pain and 10 being most painful
Pain score (NRS socre) at 12-24 hours postoperatively
时间窗: From 12 hours postoperatively to 24 hours postoperatively
NRS score: Pain was assessed on a scale of 0-10, with 0 being no pain and 10 being most painful
Pain score (NRS socre) at 6-12 hours postoperatively
时间窗: From 6 hours postoperatively to 12 hours postoperatively
NRS score: Pain was assessed on a scale of 0-10, with 0 being no pain and 10 being most painful
次要结局
- The number of patient controlled analgesia pump pressed(0-48 hours postoperatively)
- Pressure pain threshold at 30min after surgery(Change from baseline to 30 minutes postoperatively)
- Patient controlled analgesia pump analgesic consumption(0-48 hours postoperatively)
- Pressure pain threshold at 24 hours after surgery(Change from baseline to 30 min postoperatively)
- Pressure pain tolerance at 30min hours after surgery(Change from baseline to 24 hours postoperatively)