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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VPIA remifentanil | VPIA remifentanil labour analgesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VPIA remifentanil | Device | Vital signs controlled patient assisted intravenous analgesia using remifentanil |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain score | Hourly maternal pain scores | Duration of labour |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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Term parturients presenting to the hospital delivery suite in labour
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| Name | Affiliation | Role |
|---|---|---|
| Wan Ling Leong, MBBS FANZCA | KK Women's & Children's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| KK Women's & Children's Hospital | Singapore | Singapore | Singapore |
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| ID | Term |
|---|---|
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 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 |