Skip to main content
OpenTrials
Completed

NCT Number: NCT02122705

A Case Series of VPIA Using Remifentanil for Labour and Delivery

This study is a prospective case series aiming to evaluate a new VPIA remifentanil algorithm which would benefit labouring mothers who are unable or unwilling to receive epidural analgesia.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–45 year

Sex eligibility

Female

Study type

Observational

Primary location

KK Women's & Children's Hospital

Singapore

About this study

This study proposes a novel Vital signs-controlled, patient-assisted intravenous analgesia (VPIA) regimen that will enhance the efficacy, safety and personalization of remifentanil therapy for labouring women. This system will study the parturient's pattern of analgesic use in 15 min epochs and titrate the demand doses and basal infusion rate to maintain a plasma level of remifentanil that is appropriate for the degree of pain felt.

The system incorporates vital signs (pulse oximetry and heart rate values) into the algorithm which would temporarily stop the pumps and step down doses accordingly when predefined critical values are reached.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients who choose to use parenteral opioid for pain relief with informed consent
  • Patients who refuse labour epidural analgesia
  • Patients with contraindication to epidural analgesia (eg. Thrombocytopaenia, previous thoraco-lumbar spinal instrumentation)

Exclusion criteria

  • Patients who are unable to understand instructions given regarding the use of patient controlled analgesia (PCA) or unable to self administer PCA boluses
  • Patients with difficulty in communication due to language differences
  • Patients with known hypersensitivity to remifentanil or any component of its formulation or to other fentanyl analogs
  • Patients with severe respiratory disease
  • Patients with history of drug dependence of recreational drug abuse
  • Patients with unmanaged foetal bradycardia

Treatment and study plan

VPIA remifentanil

Device

Vital signs controlled patient assisted intravenous analgesia using remifentanil

Primary outcomes

  1. Pain score

    Time frame: Duration of labour

    Hourly maternal pain scores

Secondary outcomes

  1. Remifentanil drug consumption

    Time frame: Duration of labour

    Total and hourly remifentanil drug consumption.

  2. Maternal side effects

    Time frame: Duration of labour and 1st day post delivery

    Incidence of side effects : sedation, respiratory depression, oxygen desaturation, bradycardia, pruritus, nausea and vomiting

  3. Maternal outcomes

    Time frame: Duration of labour and one day post delivery

    Mode of delivery Duration of second stage Overall satisfaction with labour analgesia

Other outcomes

  1. Neonatal outcomes

    Time frame: Duration of labour and one day post delivery

    Birth weight APGAR scores at 1 and 5 minutes umbilical cord blood pH

Sponsors and collaborators

Lead sponsor

KK Women's and Children's Hospital

Other Gov

Registry information

Official study title

A Case Series of Vital Signs-controlled, Patient Assisted Intravenous Analgesia (VPIA) Using Remifentanil for Labour and Delivery

Acronym: VPIA

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Apr 24, 2014
Registry last updated
Feb 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.