A Case Series of VPIA Using Remifentanil for Labour and Delivery

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Labor Pain

Intervention / Treatment
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* Device: VPIA remifentanil


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| VPIA remifentanil<br>VPIA remifentanil labour analgesia | Device: VPIA remifentanil<br>* Vital signs controlled patient assisted intravenous analgesia using remifentanil<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Remifentanil, Labour analgesia