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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT01160965
• Date of registration: 07/07/2010
• Prospective Registration: Yes
• Primary sponsor: Guy's and St Thomas' NHS Foundation Trust
• Public title: Ropivacaine 0.75% Versus Levobupivacaine 0.5% for Conversion of Labour Epidural RoLe
• Scientific title: Ropivacaine 0.75% Versus Levobupivacaine 0.5% for Conversion of Labour Epidural to Surgical Anaesthesia for Emergency Caesarean Section.
• Date of first enrolment: August 2012
• Target sample size: 0
• Recruitment status: Withdrawn
• URL: http://clinicaltrials.gov/show/NCT01160965
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

United Kingdom

Contacts

• Name: geraldine e o'sullivan, MBBCh
• Affiliation: Guy's and St Thomas' NHS Foundation Trust

Key inclusion & exclusion 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. -



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Caesarean Section

Intervention(s)

Drug: 0.5% levobupivacaine

Drug: 0.75% Ropivacaine

Primary Outcome(s)

Supplementation Rate [Time Frame: During operation (approximately 1 hour )]

Secondary Outcome(s)

Pre-operative supplementation [Time Frame: 10-45mins (top-up to start of surgery)]

Side effects [Time Frame: At any point between top-up of epidural and end of operation (approximately 90mins from epidural top-up)]

Conversion Rate [Time Frame: At any point between epidural top-up and end of operation (approximately 90mins from epidural top-up)]

Motor block [Time Frame: prior to top-up and prior to leaving theatre (approximatelty 120 minutes from epidural top-up).]

Blood pressure supplementation rate [Time Frame: At any point from top-up of epidural to end of operation (approximately 90mins from epidural top-up)]

Onset Time [Time Frame: From administration of epidural top-up (approximately 10-45 minutes)]

Patient Satisfaction [Time Frame: Prior to leaving operating theatre (approximatelty 120 minutes from epidural top-up)]

Pain [Time Frame: During operation (approximately 1 hour)]

Fetal Wellbeing [Time Frame: After delivery (approximately 5-10 minutes from start of surgery)]

Secondary ID(s)

2010-021783-15

Version1.0

Source(s) of Monetary Support

Please refer to primary and secondary sponsors