Ropivacaine 0.75% Versus Levobupivacaine 0.5% for Conversion of Labour Epidural (RoLe)
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|ClinicalTrials.gov Identifier: NCT01160965|
Recruitment Status : Withdrawn (Not able provide staff for recruting at present)
First Posted : July 13, 2010
Last Update Posted : December 29, 2011
|Condition or disease||Intervention/treatment||Phase|
|Caesarean Section||Drug: 0.5% levobupivacaine Drug: 0.75% Ropivacaine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|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|
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.
- 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.
- 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.
- Pain [ Time Frame: During operation (approximately 1 hour) ]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) ]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) ]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) ]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) ]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). ]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) ]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.
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 ClinicalTrials.gov identifier (NCT number): NCT01160965
|St Thomas' Hospital|
|London, United Kingdom, SE1 7EH|
|Study Director:||geraldine e o'sullivan, MBBCh||Guy's and St Thomas' NHS Foundation Trust|