Ropivacaine 0.75% Versus Levobupivacaine 0.5% for Conversion of Labour Epidural (RoLe)

Ropivacaine 0.75% Versus Levobupivacaine 0.5% for Conversion of Labour Epidural to Surgical Anaesthesia for Emergency Caesarean Section.

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.

Study Overview

• Status: Withdrawn
• Conditions: Caesarean Section
• Intervention / Treatment: Drug: 0.5% levobupivacaine; Drug: 0.75% Ropivacaine

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 also found to be more efficacious at preventing 'breakthrough' pain and therefore had a lower intra-operative supplementation rate. Unfortunately the study was probably not powered adequately to confirm this finding. Bupivacaine has now largely been replaced in the this field by the less cardio-toxic stereoisomer levobupivacaine. A trial comparing 0.75% ropivacaine to 0.5% levobupivacaine and a lignocaine/adrenaline/fentanyl mixture was conducted in Singapore in 20082. It did not show a clinical difference between any of the agents. Whether the population studied is comparable to that in the UK is doubtful and it was not adequately powered to detect a difference in intra-operative supplementation rate. Local experience has shown ropivacaine 0.75% to provide a block with a rapid onset that has little requirement for supplementation intra-operatively. The need to supplement a local anaesthetic block during surgery means that the mother is experiencing a degree of pain that is unacceptable and we view this as a major consideration in choice of local anaesthetic for an epidural top-up. Whilst speed of onset is important, in that it influences the decision to delivery time of the baby, the evaluation of intraoperative supplementation will be a major focus of this trial.

• Study Type: Interventional
• Phase: Phase 4

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 7EH
    • St Thomas' Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 46 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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. -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 0.5% levobupivacaine; Participants given 15mls of 0.5% levobupivacaine as the solution for their epidural top-up	Drug: 0.5% levobupivacaine; 15mls of a 5mg/ml solution of the local anaesthetic levobupivacaine given via the epidural catheter.; Other Names: 0.5% Chirocaine
Active Comparator: 0.75% Rpoivacaine; Participants given 15mls of 0.75% ropivacaine as the solution for their epidural top-up.	Drug: 0.75% Ropivacaine; 15mls of a 7.5mg/ml solution of the local anaesthetic ropivacaine given via the epidural catheter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Supplementation Rate	The number of times the epidural anaesthetic requires intra-operative supplementation with more study solution or another drug for pain.	During operation (approximately 1 hour )

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre-operative supplementation	If further 5mls of study solution is required to achieve block height suitable for surgery to start.	10-45mins (top-up to start of surgery)
Pain	Incidence of breakthrough pain and its intensity during the operative phase of the Caesarean section	During operation (approximately 1 hour)
Conversion Rate	If the epidural anaesthetic needs to be converted to spinal anaesthetic or general anaesthetic as it is not adequate for conduction of a Caesarean section	At any point between epidural top-up and end of operation (approximately 90mins from epidural top-up)
Side effects	Occurrence of any of nausea, vomiting, itching and shivering during the specified time period	At any point between top-up of epidural and end of operation (approximately 90mins from epidural top-up)
Blood pressure supplementation rate	Use of the vasopressor phenylephrine and Hartmannn's solution to be given if mean arterial BP drops greater than 30% below baseline or systolic BP of <100mg Hg.	At any point from top-up of epidural to end of operation (approximately 90mins from epidural top-up)
Patient Satisfaction	Maternal satisfaction, asked to verbally score from 1-10 their satisfaction with the anaesthetic.	Prior to leaving operating theatre (approximatelty 120 minutes from epidural top-up)
Motor block	Scored using the Bromage scoring system asking patient to raise legs and noting how able they are to do this.	prior to top-up and prior to leaving theatre (approximatelty 120 minutes from epidural top-up).
Fetal Wellbeing	Neonatal Apgar scores at 1 and 5 minutes after delivery. pH of umbilical blood following delivery	After delivery (approximately 5-10 minutes from start of surgery)
Onset Time	The time elapsed between administration of the top-up and onset of anaesthesia suitable for surgery to proceed. Defined as a loss of sensation to cold to T4 dermatomal level.	From administration of epidural top-up (approximately 10-45 minutes)

Collaborators and Investigators

• Sponsor: Guy's and St Thomas' NHS Foundation Trust
• Investigators: Study Director: geraldine e o'sullivan, MBBCh, Guy's and St Thomas' NHS Foundation Trust

Publications and helpful links

General Publications

• Sanders RD, Mallory S, Lucas DN, Chan T, Yeo S, Yentis SM. Extending low-dose epidural analgesia for emergency Caesarean section using ropivacaine 0.75%. Anaesthesia. 2004 Oct;59(10):988-92. doi: 10.1111/j.1365-2044.2004.03753.x.
• Sng BL, Pay LL, Sia AT. Comparison of 2% lignocaine with adrenaline and fentanyl, 0.75% ropivacaine and 0.5% levobupivacaine for extension of epidural analgesia for urgent caesarean section after low dose epidural infusion during labour. Anaesth Intensive Care. 2008 Sep;36(5):659-64. doi: 10.1177/0310057X0803600505.

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Anticipated): August 1, 2013
• Study Completion (Anticipated): August 1, 2014

Study Registration Dates

• First Submitted: July 7, 2010
• First Submitted That Met QC Criteria: July 12, 2010
• First Posted (Estimate): July 13, 2010

Study Record Updates

• Last Update Posted (Estimate): December 29, 2011
• Last Update Submitted That Met QC Criteria: December 28, 2011
• Last Verified: December 1, 2011

More Information

Terms related to this study

• Keywords: epidural top-up; emergency Caesarean section
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine; Levobupivacaine
• Other Study ID Numbers: version1.0; 2010-021783-15 (EudraCT Number)