Development of Variable Volume Automated Mandatory Boluses for Patient-controlled Epidural Analgesia During Labour
Recruiting
Phase 3
Interventional Study
Labor Pain
Breakthrough Pain
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 21 – 50
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 216 (estimated)
- Sponsor
- KK Women's and Children's Hospital · Government
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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.
Trial Locations
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Eligibility 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 epi…
Contacts