A Case Series of VPIA Using Remifentanil for Labour and Delivery

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02122705

Acronym

VPIA

Enrollment

Registered

2014-04-24

Start date

2012-05-31

Completion date

2016-06-30

Last updated

2017-02-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor Pain

Keywords

Remifentanil, Labour analgesia

Brief summary

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.

Detailed description

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.

Interventions

DEVICEVPIA remifentanil

Vital signs controlled patient assisted intravenous analgesia using remifentanil

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 45 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Pain score	Duration of labour	Hourly maternal pain scores

Secondary

Measure	Time frame	Description
Remifentanil drug consumption	Duration of labour	Total and hourly remifentanil drug consumption.
Maternal side effects	Duration of labour and 1st day post delivery	Incidence of side effects : sedation, respiratory depression, oxygen desaturation, bradycardia, pruritus, nausea and vomiting
Maternal outcomes	Duration of labour and one day post delivery	Mode of delivery Duration of second stage Overall satisfaction with labour analgesia

Other

Measure	Time frame	Description
Neonatal outcomes	Duration of labour and one day post delivery	Birth weight APGAR scores at 1 and 5 minutes umbilical cord blood pH

Countries

Singapore

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026