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

Last updated: October 8, 2024
Sponsor: KK Women's and Children's Hospital
Overall Status: Active - Recruiting

Phase

3

Condition

Acute Pain

Treatment

Epidural infusion pump

Fentanyl

Ropivacaine

Clinical Study ID

NCT04011150
AM/CT001/2018
  • Ages 21-50
  • Female

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.

Eligibility Criteria

Inclusion

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 epiduralanalgesia (CSEA) according to protocol.

Exclusion

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 onmedication) and uncontrolled medical (e.g. cardiac disease) complications;

  • Have contraindications to neuraxial blockade or have received parenteral opioidswithin last 2 hours;

  • Dural puncture/ suspected dural puncture at initiation of CSEA.

Study Design

Total Participants: 216
Treatment Group(s): 3
Primary Treatment: Epidural infusion pump
Phase: 3
Study Start date:
August 11, 2020
Estimated Completion Date:
August 31, 2026

Study 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 is also higher risk of motor blockade found in those receiving epidural analgesia, and these factors is associated with dysfunctional labour requiring obstetric intervention (instrumental delivery). Automated mandatory bolus (AMB) of variable-frequency (VAMB) has been shown to provide better pain relief as compared with conventional patient-controlled epidural analgesia (PCEA) with basal infusion, however its long lockout time per hour is associated with unsuccessful patient bolus requests, with similar motor block to conventional regimens.

The investigators therefore proposes to develop a novel epidural delivery regimen: Variable volume 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. This algorithm development including pilot and clinical trial will compare VVAMB with VAMB regimens, in reducing the incidence of motor block in 216 term women requesting for labour epidural analgesia.

Connect with a study center

  • KK Women's and Children's Hospital

    Singapore, 229899
    Singapore

    Active - Recruiting

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