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Phase 3
Age: 21Years - 50Years
FEMALE
ID04011150

Study of Variable Volume Automated Mandatory Boluses for Patient-Controlled Epidural Pain Relief During Labour and Delivery

Led by KK Women's and Children's Hospital · Updated on 2024-10-09

216

Participants Needed

1

Research Sites

34 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating a new method of delivering epidural analgesia during labour to improve pain relief and reduce motor block, which can lead to fewer instrumental deliveries. The study focuses on term, healthy first-time mothers with singleton pregnancies in early labour. The trial compares a novel variable volume automated mandatory bolus VVAMB regimen against a variable-frequency automated mandatory bolus VAMB to better individualize pain management. Participants receive epidural analgesia using an infusion pump delivering a combination of ropivacaine and fentanyl. One group receives the VVAMB program, which uses higher doses at lower frequency, allowing patients to control additional pain relief via a button. The other group uses the VAMB program with lower doses at higher frequency and similar patient control. The study includes a randomized, double-blind design comparing these two regimens. During labour, researchers will monitor pain relief effectiveness, incidence of motor block, and need for instrumental delivery. They will also assess breakthrough pain episodes and newborn health using the APGAR score right after delivery. The study involves close monitoring of participants during labour, with data collected on pain control and motor function. Participation spans the labour period, with outcomes assessed primarily on the day of delivery.

CONDITIONS

Brief Title

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

Research Team

B

Ban Leong Sng, FANZCA

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