Development of Variable Volume Automated Mandatory Boluses for Patient-controlled Epidural Analgesia During Labour

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age21-50
SponsorKK Women's and Children's Hospital

About this trial

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 criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Epidural infusion pump
  • Ropivacaine
  • Fentanyl

Treatment groups

216 Participants
are divided into 2 treatment groups