Levobupivacaine Continuous Wound Infiltration and Optimal Standard Analgesia Versus Optimal Standard Analgesia Alone After Cesarean Section.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Postoperative morphine consumption
研究概览
简要总结
The purpose of this study is to determine wether wound infiltration brings additional analgesia effect after cesarean section with optimal standard postoperative analgesia
详细描述
Continuous wound infiltration with local anaesthetic has been shown as a safe and opioid-sparing analgesic method after caesarean section with minimal standard analgesia. We aim to evaluate if this benefit remains when an optimal analgesia is used.
Primary outcome is morphine consumption. Secondary outcomes is pain scores, maternal recovery including breastfeeding, side effects of morphine, nurse workload and maternal satisfaction.
Patients scheduled for caesarean delivery will be eligible for the study.
Patients with emergency caesarean delivery, contraindication to analgesic drugs, hemostasis disorder, ongoing infection, diabetes treated with insulin or chronic opioid use will be excluded from the study.
One group will receive standard analgesia including celecoxib and intravenous morphine for 24 hours with Patient Controlled Analgesia pump. The other group will receive the same standard analgesia with additional levobupivacaine initial bolus followed by a continuous subfascial infiltration of 1.25 mg/ml at 5 ml/h for 48 hours through a multiperforated catheter connected to an elastomeric pump.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Scheduled cesarean section
排除标准
- •Emergency cesarean section
- •Contraindication to opioids, paracetamol, or local anaesthetic
- •Ongoing infection
- •Coagulation disorders
- •Diabetes treated with insulin
- •Chronic opioid use
结局指标
主要结局
Postoperative morphine consumption
时间窗: 24 first hours after cesarean section
Quantity of morphine injected by the patient controlled analgesia pump
次要结局
- Technical problems related to the catheter(During the 48 first hours after skin closure)
- Pain at rest(4, 8, 12, 16, 20, 24, 36, 48 and 78 hours after skin closure, entrance and exit from the recovery room)
- Pain at mobilization(4, 8, 12, 16, 20, 24, 36, 48 and 78 hours after skin closure, entrance and exit from the recovery room)
- Early walking(in the 72 first hours after skin closure)
- Resumption of gastrointestinal function(First 72 hours after skin closure)
- Treatment tolerance(First 72 hours after skin closure)
- Maternal satisfaction(2 days after skin closure)
- Health staff workload(For the 48 first hours after skin closure)
- Wound infections(the first 10 days after skin closure)
- Local anaesthetic systemic toxicity(During the first 48 hours after skin closure)
- Discomfort due to material(At catheter retrieval)
- Comfort with Breast Feeding(For the the 48 first hours after skin closure)
- All cause morbidity(For the first 10 days after skin closure)
研究者
Claude JOLLY
MD
Poissy-Saint Germain Hospital