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

NCT04011150 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 216

Last updated 2024-10-09

No results posted yet for this study

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.

Conditions

  • Labor Pain
  • Breakthrough Pain

Interventions

DEVICE

Epidural 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.

DRUG

Ropivacaine

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

DRUG

Fentanyl

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

Sponsors & Collaborators

  • KK Women's and Children's Hospital

    lead OTHER_GOV

Principal Investigators

  • Wan Ling Leong, FANZCA · KK Women's and Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-11
Primary Completion
2025-12-31
Completion
2026-08-31

Countries

  • Singapore

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04011150 on ClinicalTrials.gov