Is Continuous Wound Infusion With Ropivacaine Better Than Intrathecal Morphine for Post-caesarean Analgesia? A Prospective, Randomized, Controlled, Double Blinded Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 192
- 试验地点
- 1
- 主要终点
- Duration of Effective Analgesia
研究概览
简要总结
The aim of this study is to compare effective analgesia with continuous wound infiltration of ropivacaine through multi-holed catheter or with morphine 100 mcg added intrathecally to spinal anesthesia, after elective Caesarean delivery.
详细描述
Double blind, 3 groups
- Control group: Rachi 0,1 ml saline, Infusion 300ml saline
- Group rachi-morphine: 0,1ml =100µg morphine/300ml saline
- Group KT: 0,1 ml saline/300 ml naropin 0.2%
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years and more, ASA 1 or ASA 2, pregnant with at least 34 weeks of gestational age, admitted for a planned caesarian with a Pfannenstiel incision and having signed the informed consent form.
排除标准
- •Refusal of the patient or contra-indication to locoregional anesthesia
- •Allergy to the products used
- •Sleep apnea syndrome and/or obesity (BMI > 35)
- •Size inferior to 155cm
- •existence of a language barrier
研究组 & 干预措施
ropivacaine infiltration
ropivacaine 2 mg/ml bolus 15 ml continuous 10 ml/h wound infusion and intrathecal saline
干预措施: ropivacaine infiltration (Drug)
rachi morphine
100 µg intrathecal morphine and saline infiltration
干预措施: intrathecal morphine (Drug)
placebo
intrathecal saline and saline infiltration
干预措施: placebo (Drug)
结局指标
主要结局
Duration of Effective Analgesia
时间窗: 30 hours after spinal injection T0
T0 until first request of morphine PCAIV
Morphine Consumption
时间窗: 30 hours after spinal injection T0
Morphine consumption with PCAIV
次要结局
- Incidence of Morphine Side Effects: Nausea, Vomiting, Pruritus.(30 hours after spinal injection)
研究者
Dr Madeleine Wilwerth
Primary Investigator
Brugmann University Hospital