Development of Variable Volume Automated Mandatory Boluses for Patient-controlled Epidural Analgesia During Labour
Development of Variable Volume Automated Mandatory Boluses (VVAMB) for Patient-controlled Epidural Analgesia During Labour and Delivery
KK Women's and Children's Hospital
216 participants
Aug 11, 2020
INTERVENTIONAL
Conditions
Summary
A novel epidural delivery regimen was developed: Variable volume automated mandatory bolus (AMB) (VVAMB) will advance individualisation of labour epidural analgesia, by which a larger volume of bolus may contribute to better spread of the local anaesthetics within brief period and thereby reduces the chances of motor blockade that could reduce instrumental deliveries.
Eligibility
Inclusion Criteria4
- Healthy (American Society of Anesthesiologists (ASA) physical status 1 and 2) primiparous parturient at term (≥36 weeks gestation);
- Singleton fetus;
- In early labor stage (cervical dilation ≤5cm);
- Request labor epidural analgesia and able to administer combined spinal epidural analgesia (CSEA) according to protocol.
Exclusion Criteria4
- Non-cephalic fetal presentation;
- Obstetric (e.g. pre-eclampsia, premature rupture of amniotic membranes for more than 48 hours, gestational diabetes on insulin, pregnancy-induced hypertension on medication) and uncontrolled medical (e.g. cardiac disease) complications;
- Have contraindications to neuraxial blockade or have received parenteral opioids within last 2 hours;
- Dural puncture/ suspected dural puncture at initiation of CSEA.
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Interventions
Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution.
Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution.
Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution.
Locations(1)
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NCT04011150