Ropivacaine 0.75% versus Levobupivacaine 0.5% for conversion of labour epidural to surgical anaesthesia for emergency Caesarean section. (RoLe Trial) - RoLe Study

Guys and St Thomas' NHS Foundation Trust0 个研究点目标入组 150 人开始时间: 2010年12月14日最近更新: 2012年10月2日

适应症

试验速览

暂无简介。

•Any subject requiring a grade 2 or 3 EmCS on the Hospital Birth Centre, St Thomas’ who has:
•1.Labour analgesia provided by the standard patient controlled epidural (solution containing 0.1% levobupivacaine and 2mcg/ml fentanyl). That is providing analgesia via the patient controlled epidural analgesia infusion pump without the need for multiple extra boluses of epidural local anaesthetic and or opiates from the anaesthetist on the labour ward..
•2.Singleton pregnancy.
•3.Established labour, determined by the midwife responsible for the patient (usually by vaginal examination of the cervix).
•4.Gestation >36 weeks
•5.No complex past medical history according to the judgement of the investigator
•6.> 18 years of age
•7.EmCS starts between the hours 0800 and 1800.
•8.Had a minimum total dose of 50mcg of fentanyl via the epidural since its insertion.
•9.The ability to understand the patient information sheet and willing to provide informed consent.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Any of the following conditions or situations would preclude involvement in the trial:
•1.Pre-eclampsia / Eclampsia
•2.Antepartum haemorrhage
•3.Any congenital, valvular or ischaemic heart disease.
•4.Category 1 EmCS.
•5.Participation in another therapeutic study in the last 12 weeks.

发起方

Guys and St Thomas' NHS Foundation Trust