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

2014-07-23 21:08:28 | BioPortfolio

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.

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Caesarean Section

Intervention

0.5% levobupivacaine, 0.75% Ropivacaine

Location

St Thomas' Hospital
London
United Kingdom
SE1 7EH

Status

Not yet recruiting

Source

Guy's and St Thomas' NHS Foundation Trust

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:08:28-0400

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Medical and Biotech [MESH] Definitions

Abnormal increase in RESPIRATORY RATE in the newborn. It is self-limiting and attributed to the delayed fetal lung fluid clearance often in CAESAREAN SECTION delivery.

Surgical removal of a section of the iris.

Extraction of the FETUS by means of abdominal HYSTEROTOMY.

The anteriorly located rigid section of the PALATE.

The part of a limb or tail following amputation that is proximal to the amputated section.

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