RecruitingPhase 3NCT04011150

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

Development of Variable Volume Automated Mandatory Boluses (VVAMB) for Patient-controlled Epidural Analgesia During Labour and Delivery

Sponsor

KK Women's and Children's Hospital

Enrollment

216 participants

Start Date

Aug 11, 2020

Study Type

INTERVENTIONAL

Conditions

Labor Pain Breakthrough Pain

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.

Eligibility

Sex: FEMALEMin Age: 21 YearsMax Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Epidural infusion pump, a drug called Fentanyl, and others for people with breakthrough pain and labor pain. The study is currently recruiting participants at 1 location. People eligible for this study include women aged 21 Years to 50 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEEpidural infusion pump

Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution.

DRUGRopivacaine

Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution.

DRUGFentanyl

Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution.