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

Recruiting now · Phase 3

Conditions studied: Labor Pain, Breakthrough Pain

In brief

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.

Key facts

Study ID

NCT04011150

Run by

KK Women's and Children's Hospital

People needed

216

Starts

2020-08-11

Expected to finish

2026-08-31

Last updated by the study team

2024-10-09

Who can join

Age: 21 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• KK Women's and Children's Hospital — Singapore, Singapore (enrolling)

Full record on ClinicalTrials.gov

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