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

This study has been withdrawn prior to enrollment.
(Not able provide staff for recruting at present)
Sponsor:
Information provided by:
Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01160965
First received: July 7, 2010
Last updated: December 28, 2011
Last verified: December 2011
  Purpose

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 Intervention Phase
Caesarean Section
Drug: 0.5% levobupivacaine
Drug: 0.75% Ropivacaine
Phase 4

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

Resource links provided by NLM:


Further study details as provided by Guy's and St Thomas' NHS Foundation Trust:

Primary Outcome Measures:
  • Supplementation Rate [ Time Frame: During operation (approximately 1 hour ) ] [ Designated as safety issue: No ]
    The number of times the epidural anaesthetic requires intra-operative supplementation with more study solution or another drug for pain.


Secondary Outcome Measures:
  • Pre-operative supplementation [ Time Frame: 10-45mins (top-up to start of surgery) ] [ Designated as safety issue: No ]
    If further 5mls of study solution is required to achieve block height suitable for surgery to start.

  • Pain [ Time Frame: During operation (approximately 1 hour) ] [ Designated as safety issue: No ]
    Incidence of breakthrough pain and its intensity during the operative phase of the Caesarean section

  • Conversion Rate [ Time Frame: At any point between epidural top-up and end of operation (approximately 90mins from epidural top-up) ] [ Designated as safety issue: No ]
    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

  • Side effects [ Time Frame: At any point between top-up of epidural and end of operation (approximately 90mins from epidural top-up) ] [ Designated as safety issue: No ]
    Occurrence of any of nausea, vomiting, itching and shivering during the specified time period

  • Blood pressure supplementation rate [ Time Frame: At any point from top-up of epidural to end of operation (approximately 90mins from epidural top-up) ] [ Designated as safety issue: No ]
    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.

  • Patient Satisfaction [ Time Frame: Prior to leaving operating theatre (approximatelty 120 minutes from epidural top-up) ] [ Designated as safety issue: No ]
    Maternal satisfaction, asked to verbally score from 1-10 their satisfaction with the anaesthetic.

  • Motor block [ Time Frame: prior to top-up and prior to leaving theatre (approximatelty 120 minutes from epidural top-up). ] [ Designated as safety issue: No ]
    Scored using the Bromage scoring system asking patient to raise legs and noting how able they are to do this.

  • Fetal Wellbeing [ Time Frame: After delivery (approximately 5-10 minutes from start of surgery) ] [ Designated as safety issue: No ]
    Neonatal Apgar scores at 1 and 5 minutes after delivery. pH of umbilical blood following delivery

  • 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.


Enrollment: 0
Study Start Date: August 2012
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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. -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01160965

Locations
United Kingdom
St Thomas' Hospital
London, United Kingdom, SE1 7EH
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
Investigators
Study Director: geraldine e o'sullivan, MBBCh Guy's and St Thomas' NHS Foundation Trust
  More Information

Publications:
Responsible Party: Dr Geraldine O'Sullivan (Consultant Anaesthetist), Guy's & St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01160965     History of Changes
Other Study ID Numbers: Version1.0, 2010-021783-15
Study First Received: July 7, 2010
Last Updated: December 28, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Guy's and St Thomas' NHS Foundation Trust:
epidural top-up
emergency Caesarean section

Additional relevant MeSH terms:
Ropivacaine
Levobupivacaine
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 22, 2014