A Case Series of VPIA Using Remifentanil for Labour and Delivery (VPIA)

A Case Series of Vital Signs-controlled, Patient Assisted Intravenous Analgesia (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.

Study Overview

• Status: Completed
• Conditions: Labor Pain
• Intervention / Treatment: Device: VPIA remifentanil

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.

• Study Type: Observational
• Enrollment (Actual): 29

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore
    • KK Women's & Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Term parturients presenting to the hospital delivery suite in labour

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
VPIA remifentanil; VPIA remifentanil labour analgesia	Device: VPIA remifentanil; Vital signs controlled patient assisted intravenous analgesia using remifentanil

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Other Outcome Measures

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

Collaborators and Investigators

• Sponsor: KK Women's and Children's Hospital
• Investigators: Principal Investigator: Wan Ling Leong, MBBS FANZCA, KK Women's & Children's Hospital

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: April 23, 2014
• First Submitted That Met QC Criteria: April 23, 2014
• First Posted (Estimate): April 24, 2014

Study Record Updates

• Last Update Posted (Estimate): February 7, 2017
• Last Update Submitted That Met QC Criteria: February 5, 2017
• Last Verified: September 1, 2015

More Information

Terms related to this study

• Keywords: Remifentanil; Labour analgesia
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Remifentanil
• Other Study ID Numbers: CIRB/2012/264/D

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No