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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01160965
Recruitment Status : Withdrawn (Not able provide staff for recruting at present)
First Posted : July 13, 2010
Last Update Posted : December 29, 2011
Information provided by:
Guy's and St Thomas' NHS Foundation Trust

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 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.

Condition or disease Intervention/treatment Phase
Caesarean Section Drug: 0.5% levobupivacaine Drug: 0.75% Ropivacaine Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ropivacaine 0.75% Versus Levobupivacaine 0.5% for Conversion of Labour Epidural to Surgical Anaesthesia for Emergency Caesarean Section.
Study Start Date : August 2012
Estimated Primary Completion Date : August 2013
Estimated Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

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 Name: 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.

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

Secondary Outcome Measures :
  1. Pre-operative supplementation [ Time Frame: 10-45mins (top-up to start of surgery) ]
    If further 5mls of study solution is required to achieve block height suitable for surgery to start.

  2. Pain [ Time Frame: During operation (approximately 1 hour) ]
    Incidence of breakthrough pain and its intensity during the operative phase of the Caesarean section

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

  4. Side effects [ Time Frame: At any point between top-up of epidural and end of operation (approximately 90mins from epidural top-up) ]
    Occurrence of any of nausea, vomiting, itching and shivering during the specified time period

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

  6. Patient Satisfaction [ Time Frame: Prior to leaving operating theatre (approximatelty 120 minutes from epidural top-up) ]
    Maternal satisfaction, asked to verbally score from 1-10 their satisfaction with the anaesthetic.

  7. Motor block [ Time Frame: prior to top-up and prior to leaving theatre (approximatelty 120 minutes from epidural top-up). ]
    Scored using the Bromage scoring system asking patient to raise legs and noting how able they are to do this.

  8. Fetal Wellbeing [ Time Frame: After delivery (approximately 5-10 minutes from start of surgery) ]
    Neonatal Apgar scores at 1 and 5 minutes after delivery. pH of umbilical blood following delivery

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

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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. -

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01160965

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United Kingdom
St Thomas' Hospital
London, United Kingdom, SE1 7EH
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
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Study Director: geraldine e o'sullivan, MBBCh Guy's and St Thomas' NHS Foundation Trust
Publications of Results:
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Responsible Party: Dr Geraldine O'Sullivan (Consultant Anaesthetist), Guy's & St Thomas' NHS Foundation Trust Identifier: NCT01160965    
Other Study ID Numbers: Version1.0
2010-021783-15 ( EudraCT Number )
First Posted: July 13, 2010    Key Record Dates
Last Update Posted: December 29, 2011
Last Verified: December 2011
Keywords provided by Guy's and St Thomas' NHS Foundation Trust:
epidural top-up
emergency Caesarean section
Additional relevant MeSH terms:
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Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents