RoLe Study (Version 1)

• Research type

  Research Study

• Full title

  Ropivacaine 0.75% versus Levobupivacaine 0.5% for conversion of labour epidural to surgical anaesthesia for emergency Caesarean section. (RoLe Trial)

• IRAS ID

  56862

• Contact name

  Geraldine O-Sullivan

• Sponsor organisation

  Guy's & St Thomas' NHS Foundation Trust

• Eudract number

  2010-021783-15

• ISRCTN Number

  isrctn

• Research summary

  Study to evaluate which of 0.5% levobupivaciane or 0.75% ropivacaine is the better local anaesthetic to use when topping up a labour epidural to provide anaesthesia suitable for an emergency Caesarean section. Over 25,000 emergency caesarean sections are performed using epidural top-ups each year in the UK, yet there remains considerable debate as to which local anaesthetic should used. Ropivacaine has in one previous trial looked promising, but it did not have enough Participants to demonstrate a difference and wasn't compared to the now more commonly used levobupivacaine. When looking at the best characteristics of an epidural top-up solution then the speed at which it provides surgical anaesthesia and a low occurrence of pain during the operative phase of caesarean section are usually considered as the primary endpoints. In this trial we will compare the two local anaesthetics in respect to these qualities to determine which is superior. The trial will include women with an epidural In-situ that progress to requiring an emergency caesarean section for delivery of their baby. It will be conducted in the birth centre, St. Thomas' Hospital and recruitment will last until 100 women have been randomised to treatment. In conducting the trial the Participants treatment will be identical to that usually carried out for any emergency caesarean section in this situation.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  10/H0709/59

• Date of REC Opinion

  2 Nov 2010

• REC opinion

  Further Information Favourable Opinion