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

December 28, 2011 updated by: Guy's and St Thomas' NHS Foundation Trust

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

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
During operation (approximately 1 hour )

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
10-45mins (top-up to start of surgery)
Pain
Time Frame: During operation (approximately 1 hour)
Incidence of breakthrough pain and its intensity during the operative phase of the Caesarean section
During operation (approximately 1 hour)
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
At any point between epidural top-up and end of operation (approximately 90mins from epidural top-up)
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
At any point between top-up of epidural and end of operation (approximately 90mins 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)
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
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.
Prior to leaving operating theatre (approximatelty 120 minutes from epidural top-up)
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.
prior to top-up and prior to leaving theatre (approximatelty 120 minutes from epidural top-up).
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
After delivery (approximately 5-10 minutes from start of surgery)
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.
From administration of epidural top-up (approximately 10-45 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guy's and St Thomas' NHS Foundation Trust

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: geraldine e o'sullivan, MBBCh, Guy's and St Thomas' NHS Foundation Trust

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2012

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2013

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 7, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2010

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 29, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 28, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • version1.0
  • 2010-021783-15 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Caesarean Section

Clinical Trials on 0.5% levobupivacaine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings