A Case Series of VPIA Using Remifentanil for Labour and Delivery

Completed

• Conditions: Labor Pain
• Interventions: Device: VPIA remifentanil

• Registration Number: NCT02122705
• Lead Sponsor: KK Women's and Children's Hospital

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.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2014-04-23
• Study First Submitted QC: 2014-04-23
• Study First Posted: 2014-04-24
• Status Verified: 2015-09
• Primary Completion: 2016-01
• Study Completion: 2016-06
• Last Update Submitted: 2017-02-05
• Last Update Posted: 2017-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 29

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
VPIA remifentanil	VPIA remifentanil	VPIA remifentanil labour analgesia

Primary Outcome Measures

Name	Time	Method
Pain score	Duration of labour	Hourly maternal pain scores

Secondary Outcome Measures

Name	Time	Method
Maternal outcomes	Duration of labour and one day post delivery	Mode of delivery Duration of second stage Overall satisfaction with labour analgesia
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
Remifentanil drug consumption	Duration of labour	Total and hourly remifentanil drug consumption.

Trial Locations

Locations (1)

KK Women's & Children's Hospital; 🇸🇬 Singapore, Singapore