Comparing 0.125% and 0.0625% bupivacaine + 2mcg/ml fentanyl for maintenance of epidural labour analgesia on Delivery Unit at National Women's Hospital, Auckland - A feasibility study.
Feasibility study comparing 0.125% and 0.0625% bupivacaine + 2mcg/ml fentanyl for maintenance of labour epidural analgesia to ensure a switch to lower concentrations of local anaesthetic is non-inferior in labouring women on Delivery Unit at National Women's Hospital, Auckland.
Auckland District Health Board
200 participants
Dec 1, 2016
Interventional
Conditions
Summary
This is an interventional trial with the aim of determining the feasibility of changing to a lower concentration of local anaesthetic within our population of parturients choosing epidural analgesia for labour. There is well established evidence for the use of lower concentration local anaesthetic mixtures, and 0.0625% has been successfully used in our and other centres. A reduction in the concentration of local anaesthetic for labour epidural analgesia has both maternal and fetal benefits, including lower total local anaesthetic consumption during labour, improved mobility and increased likelihood of spontaneous vaginal delivery. As a result, the multidisciplinary team at National Women's Hospital, are keen to explore the feasibility of changing from the currently used "standard mix" 0.125% bupivacaine + 2mcg/ml fentanyl to exclusive use of a lower local anaesthetic concentration. This feasibility study will allocate women to undergo maintenance of epidural analgesia for labour using one of the two currently used mixtures of epidural drugs: 0.125% bupivacaine + 2mcg/ml fentanyl or 0.0625% bupivacaine, each with 2mcg/ml fentanyl, depending on the month of study. Epidural insertion, testing and loading will commence as per the inserting anaesthetist's normal practice. The epidural in each study arm will then be maintained with the relevant study concentration of local anaesthetic via PCEA. Outcome measures will include satisfaction with labour analgesia, requirement for additional top-ups or other staff interventions, total local anaesthetic dosages administered, duration of labour. mode of delivery, adequacy of analgesia for delivery, extent of motor blockade during labour and rates of urinary catheterisation.
Eligibility
Exclusion Criteria3
- Women undergoing epidural insertion out of hours
- Women thought likely to deliver within the forthcoming 2 hours
- Women whose lead maternity carer (LMC) is not in agreement for epidural maintenance with a patient-controlled pump
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Interventions
The purpose of this trial is to confirm that a change from the currently used epidural mix of local anaesthetic for labour analgesia in our institution to a lower concentration is non-inferior for maintenance of labour epidural analgesia and confirms the benefits seen in other institutions using these lower concentrations. We will investigate the use of two different concentrations of epidural local anaesthetic: Group 1 (first cohort) - 0.125% Bupivacaine mixed with 2mcg/ml fentanyl Group 2 (second cohort) - 0.0625% bupivacaine mixed with 2mcg/ml fentanyl. The drug mixture of bupivacaine and fentanyl for each group will be administered by patient controlled epidural analgesia (PCEA) that delivers a fixed volume of the drug mixture with a subsequent lockout where further drugs cannot be administered. The concentration being studied will be given for maintenance of their epidural for the whole of their labour from the time the epidural is established to delivery of the baby. Patient demands will be allowed up to 4 times per hour with one additional midwife-administered bolus possible per hour, and the total dose will be recorded from the pump at the end of the labour, along with the duration of the epidural. All parturients requesting epidural analgesia (other than those patients anticipated to fulfil the exclusion criteria) will be approached to participate in this study. Only one concentration of epidural drug will be administered per epidural, starting from when the epidural is initially sited and patient comfortable, until birth. The epidural pumps deliver their drugs on patient demand, with a 5 minute lockout and maximum 5 doses administered per hour; the 0.125% concentration is a 5 ml bolus, with the 0.0625% concentration a 7ml bolus. Additional rescue boluses of 10mls 0.125% bupivacaine with 2mcg/ml fentanyl are also available, administered by the anaesthetist, should the patient's epidural pain relief prove inadequate, as frequently as the anaesthetist deems necessary up to the maximum safe local anaesthetic dose for the patient (2mg/kg Bupivacaine every 4 hours). Duration of epidural and total dose administered are used to monitor drug consumption.
Locations(1)
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ACTRN12616001108404