Status:
RECRUITING
Development of Variable Volume Automated Mandatory Boluses for Patient-controlled Epidural Analgesia During Labour
Lead Sponsor:
KK Women's and Children's Hospital
Conditions:
Labor Pain
Breakthrough Pain
Eligibility:
FEMALE
21-50 years
Phase:
PHASE3
Brief 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 ...
Detailed Description
Epidural analgesia is the gold standard of pain relief for labour pain. Despite this, up to 50% of parturients continue to experience pain leading to suffering and increased caregiver workload. There ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
August 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 31 2026
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT04011150
Start Date
August 11 2020
End Date
August 31 2026
Last Update
October 9 2024
Active Locations (1)
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1
KK Women's and Children's Hospital
Singapore, Singapore, 229899