Ropivacaine 0.75% Versus Levobupivacaine 0.5% for Conversion of Labour Epidural

• Status: Withdrawn
• Trial end date: 2014-08-01
• Target enrollment: 0
• Participant gender: Female

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 emergency Caesarean section. This is a technique commonly known as an epidural top-up. The investigators set out to disprove the hypothesis that there is no difference between the 2 local anaesthetics in the time of onset and number of times epidural top-up needs supplementing during surgery.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Treatments: Bupivacaine; Levobupivacaine; Pharmaceutical Solutions; Ropivacaine

Criteria

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. The ability to understand the patient information sheet and willing to provide informed consent.

9. Had a minimal total dose of 50mcg of fentanyl since insertion of epidural

Exclusion Criteria:

1. Pre-eclampsia / Eclampsia

2. Antepartum haemorrhage

3. Any congenital, structural or ischaemic heart disease.

4. Category 1 EmCS.

5. Participation in another therapeutic study in the last 12 weeks. -