Status:
WITHDRAWN
Ropivacaine 0.75% Versus Levobupivacaine 0.5% for Conversion of Labour Epidural
Lead Sponsor:
Guy's and St Thomas' NHS Foundation Trust
Conditions:
Caesarean Section
Eligibility:
FEMALE
18-50 years
Phase:
PHASE4
Brief Summary
The aim of this trial is to compare the local anaesthetic ropivacaine to local anaesthetic levobupivacaine in converting the standard patient controlled labour epidural to provide anaesthesia for an e...
Detailed Description
In a randomised controlled trial involving 45 patients the speed of onset of the effects of 20mls of 0.75% ropivacaine was found to be similar to that of 20mls of 0.5% bupivacaine1. However it was als...
Eligibility Criteria
Inclusion
- Any subject requiring a grade 2 or 3 EmCS on the Hospital Birth Centre, St Thomas' who has:
- 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..
- Singleton pregnancy.
- Established labour, determined by the midwife responsible for the patient (usually by vaginal examination of the cervix).
- Gestation \>36 weeks
- No complex past medical history according to the judgement of the investigator
- \> 18 years of age
- EmCS starts between the hours 0800 and 1800.
- The ability to understand the patient information sheet and willing to provide informed consent.
- Had a minimal total dose of 50mcg of fentanyl since insertion of epidural
Exclusion
- Pre-eclampsia / Eclampsia
- Antepartum haemorrhage
- Any congenital, structural or ischaemic heart disease.
- Category 1 EmCS.
- Participation in another therapeutic study in the last 12 weeks. -
Key Trial Info
Start Date :
August 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01160965
Start Date
August 1 2012
End Date
August 1 2014
Last Update
December 29 2011
Active Locations (1)
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1
St Thomas' Hospital
London, United Kingdom, SE1 7EH