Clinical trial

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

Name

AM/CT001/2018

Description

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 arms

Trial start

2020-08-11

Estimated PCD

2024-12-31

Trial end

2025-08-31

Status

Recruiting

Phase

Early phase I

Treatment

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.

Arms:

Automated mandatory bolus (AMB) of variable-frequency (VAMB), Variable volume Automated Mandatory Bolus (VVAMB)

Other names:

Epidural delivery system

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.

Arms:

Automated mandatory bolus (AMB) of variable-frequency (VAMB), Variable volume Automated Mandatory Bolus (VVAMB)

Other names:

Amide local anaesthetic

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.

Arms:

Automated mandatory bolus (AMB) of variable-frequency (VAMB), Variable volume Automated Mandatory Bolus (VVAMB)

Other names:

Opioid

Size

216

Primary endpoint

Incidence of motor block in each group

During labour (1 day)

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 epidural analgesia (CSEA) according to protocol. Exclusion Criteria: * 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.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 216, 'type': 'ESTIMATED'}}

Updated at

2023-04-04

1 organization

1 product

1 drug

2 indications

Organization

KK Women's and Children's Hospital

Product

Indication

Indication

Drug