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

• Conditions: Conversion of labour epidural to surgical anaesthesia for emergency Caesarean section; MedDRA version: 12.1Level: LLTClassification code 10006924Term: Caesarean section; MedDRA version: 12.1Level: LLTClassification code 10054375Term: Epidural anesthesia

• Registration Number: EUCTR2010-021783-15-GB
• Lead Sponsor: Guys and St Thomas' NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-14
• Last Update Posted: 2 October 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 150

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified