NCT03663478已完成4 期
Ultrasound-guided Transmuscular Quadratus Lumborum Catheters for Elective Caesarean Section. A Double Blind, Randomise, Placebo Controlled Trial.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Time to first opioid
研究概览
简要总结
The aim of this study is to investigate whether it is possible to prolong time to first opioid with the TQL block by inserting catheters bilaterally, providing continuous analgesia, in patients undergoing elective CS. Our hypothesis is that it will be possible to significantly extend time to first opioid with the blockade by 66.6%, increasing it from a mean of 5.6 hours to a mean of 10 hours.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •18+ years of age.
- •Scheduled for elective Caesarean Section in spinal anaesthesia.
- •Have received thorough information, verbally and in written, and signed the "Informed Consent" form on participation in the trial.
排除标准
- •Inability to cooperate
- •Inability to understand Danish
- •Allergy to local anaesthetics or opioids
- •Excessive daily intake of opioids, according to the discretion of the investigator
- •Local infection at the site of injection or systemic infection
- •Difficult visualisation of muscular and fascial structures on ultrasound, necessary to correct blockade and catheter placement.
研究组 & 干预措施
Intervention
Active Comparator
Ropivacaine
干预措施: Ropivacaine (Drug)
Control
Placebo Comparator
Isotonic saline
干预措施: Saline (Drug)
结局指标
主要结局
Time to first opioid
时间窗: 24 hours postoperatively
The time from catheters placement to the administration of opioids
次要结局
- Pain intensity (NRS 0-10/10)(24 hours postoperatively)
- Total morphine consumption.(24 hours)
- Catheter displacement.(24 hours)
- Patient satisfaction with application of the catheters.(24 hours)
- The degree of morphine-related side effects (PONV, itching, fatigue, etc.).(24 hours)
- Time from operation to ambulation.(24 hours)
研究者
研究点 (1)
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