Comparison of Two Analgesic Strategies After Scheduled Caesarean : Block of the Lumbar Region With Ropivacaine Versus Intrathecal Morphine
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Cumulative quantity of morphine received postoperatively via pump
研究概览
简要总结
To demonstrate the superiority of square lumbar block to ropivacaine compared to intrathecal morphine in the efficacy of postoperative analgesia following scheduled caesarean.
详细描述
Interventional, comparative, randomized, controlled study versus reference therapeutic strategy, in 2 parallel groups, double-blind (patient and evaluator), single-center, aiming to demonstrate the superiority of ropivacaine in square lumbar block versus intrathecal morphine, on the efficacy of post-operative analgesia, following a scheduled caesarean.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
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
- •Patient to undergo a scheduled caesarean under spinal anesthesia, for the birth of a term baby with a Pfannenstiel-type incision;
- •Patient in good health ;
- •Patient able to understand the information related to the study, read the information leaflet and agree to sign the consent form.
排除标准
- •Pregnancy less than 37 weeks with amenorrhea;
- •Multiple pregnancy;
- •Fetal pathology known at the time of inclusion;
- •Body mass index> 45 kg / m²;
- •History of scoliosis or spine surgery;
- •History of chronic pain associated with taking opiates, neuropathic pain, neurological pathology;
- •Preoperative anemia (blood hemoglobin <9 g / dL);
- •Hypersensitivity to ropivacaine or other local anesthetics with amide bond;
- •Hypersensitivity to morphine or opioids;
研究组 & 干预措施
ropivacaine in quadratum lumburum block 2
Ropivacaine will be administrated in perineural in quadratum lumburum block 2 after the caesarian.
干预措施: Rachianesthesia (Drug)
ropivacaine in quadratum lumburum block 2
Ropivacaine will be administrated in perineural in quadratum lumburum block 2 after the caesarian.
干预措施: Morphine (Drug)
Intrathecal morphine
Morphine will be administrated in intrathecal
干预措施: Rachianesthesia (Drug)
Intrathecal morphine
Morphine will be administrated in intrathecal
干预措施: Sodium Chloride Injection (Drug)
Intrathecal morphine
Morphine will be administrated in intrathecal
干预措施: Morphine (Drug)
结局指标
主要结局
Cumulative quantity of morphine received postoperatively via pump
时间窗: 1 day
The main objective of the study is to demonstrate the superiority of square lumbar block to ropivacaine (quadratum lumburum block 2 - QLB2) in comparison to intrathecal morphine in the efficacy of postoperative analgesia following a scheduled Caesarean.
次要结局
- Cumulative quantity of morphine received postoperatively via pump(2 days)
- Characteristics of postoperative pain using a visual analogic scale(2 days)
- Side effects of the two analgesic strategies(2 days)