A Case Series of VPIA Using Remifentanil for Labour and Delivery

KK Women's and Children's Hospital29 enrolled

Overview

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.

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

Conditions

Labor Pain

Interventions

VPIA remifentanilDEVICE

Vital signs controlled patient assisted intravenous analgesia using remifentanil

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 Years

Medical Language ↔ Plain English

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

Locations (1)

KK Women's & Children's Hospital

Singapore, Singapore, Singapore

Outcomes

Primary Outcomes

Pain score

Hourly maternal pain scores

Time frame: Duration of labour

Secondary Outcomes

Remifentanil drug consumption

Total and hourly remifentanil drug consumption.

Time frame: Duration of labour

Maternal side effects

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

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

Maternal outcomes

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

Time frame: Duration of labour and one day post delivery

Data from ClinicalTrials.gov

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