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Caesarean SectionPhase 4RoLeNCT01160965

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

A Phase 4 study testing 0.5% levobupivacaine and 0.75% Ropivacaine in people with Caesarean Section, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
Caesarean Section
What is being tested?
0.5% levobupivacaine and 0.75% Ropivacaine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited Kingdom
Study dates
Aug 2012to Aug 2014
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Any subject requiring a grade 2 or 3 EmCS on the Hospital Birth Centre, St Thomas' who has:
  • 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..
  • Singleton pregnancy.
  • Established labour, determined by the midwife responsible for the patient (usually by vaginal examination of the cervix).
  • Gestation >36 weeks
  • No complex past medical history according to the judgement of the investigator
Show all 10Show fewer
  • > 18 years of age
  • EmCS starts between the hours 0800 and 1800.
  • The ability to understand the patient information sheet and willing to provide informed consent.
  • Had a minimal total dose of 50mcg of fentanyl since insertion of epidural

Who cannot join

  • Pre-eclampsia / Eclampsia
  • Antepartum haemorrhage
  • Any congenital, structural or ischaemic heart disease.
  • Category 1 EmCS.
  • Participation in another therapeutic study in the last 12 weeks. -

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • St Thomas' Hospital

    London, SE1 7EH

Other trials in United Kingdom

About this study

Official title: 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.

Read the 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.

Being tested
0.5% levobupivacaine, 0.75% Ropivacaine
Keywords
epidural top-up, emergency Caesarean section

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 0.5% levobupivacaineDrug

    Also called 0.5% Chirocaine

    15mls of a 5mg/ml solution of the local anaesthetic levobupivacaine given via the epidural catheter.

  • 0.75% RopivacaineDrug

    15mls of a 7.5mg/ml solution of the local anaesthetic ropivacaine given via the epidural catheter.

Study groups in NCT01160965
Study groupRoleWhat they receive
0.5% levobupivacaineActive comparatorParticipants given 15mls of 0.5% levobupivacaine as the solution for their epidural top-up
Receives: Drug: 0.5% levobupivacaine
0.75% RpoivacaineActive comparatorParticipants given 15mls of 0.75% ropivacaine as the solution for their epidural top-up.
Receives: Drug: 0.75% Ropivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Supplementation Rate

    The number of times the epidural anaesthetic requires intra-operative supplementation with more study solution or another drug for pain.

    Measured: During operation (approximately 1 hour )

Secondary outcomes (9)

  1. Pre-operative supplementation

    If further 5mls of study solution is required to achieve block height suitable for surgery to start.

    Measured: 10-45mins (top-up to start of surgery)

  2. Pain

    Incidence of breakthrough pain and its intensity during the operative phase of the Caesarean section

    Measured: During operation (approximately 1 hour)

  3. 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

    Measured: At any point between epidural top-up and end of operation (approximately 90mins from epidural top-up)

  4. Side effects

    Occurrence of any of nausea, vomiting, itching and shivering during the specified time period

    Measured: At any point between top-up of epidural and end of operation (approximately 90mins from epidural top-up)

  5. 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.

    Measured: At any point from top-up of epidural to end of operation (approximately 90mins from epidural top-up)

  6. Patient Satisfaction

    Maternal satisfaction, asked to verbally score from 1-10 their satisfaction with the anaesthetic.

    Measured: Prior to leaving operating theatre (approximatelty 120 minutes from epidural top-up)

  7. Motor block

    Scored using the Bromage scoring system asking patient to raise legs and noting how able they are to do this.

    Measured: prior to top-up and prior to leaving theatre (approximatelty 120 minutes from epidural top-up).

  8. Fetal Wellbeing

    Neonatal Apgar scores at 1 and 5 minutes after delivery. pH of umbilical blood following delivery

    Measured: After delivery (approximately 5-10 minutes from start of surgery)

  9. 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.

    Measured: From administration of epidural top-up (approximately 10-45 minutes)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jul 2010 (estimated)
  2. Study startAug 2012
  3. Primary completionAug 2013 (estimated)
  4. Study completionAug 2014 (estimated)

Why it stopped: Not able provide staff for recruting at present

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01160965
Sponsor's protocol ID
Version1.0
Other IDs
2010-021783-15
Acronym
RoLe
Status last verified
Dec 2011
First submitted
7 Jul 2010
Last updated
29 Dec 2011
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 15488058

  • 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.

    PubMed 18853583

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing 0.5% levobupivacaine and 0.75% Ropivacaine in people with Caesarean Section, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 29 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Supplementation Rate (time frame: During operation (approximately 1 hour )). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01160965, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2011.

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