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

• Status: Recruiting
• Trial end date: 2022-03-31
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: KK Women's and Children's Hospital
• Treatments: Analgesics, Opioid; Anesthetics; Anesthetics, Local; Fentanyl; Ropivacaine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.