Clinical trial NCT02733835: VPIA Remifentanil for Labour Pain to Reduce Maternal Desaturation and Improve Analgesic Titration
Official title: Novel Vital-sign Patient-assisted Intravenous Analgesia With Remifentanil for Labour Pain to Reduce Maternal Desaturation and Improve Analgesic Titration: a Prospective Cohort Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Labor Pain
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
First posted: 2016-04-12
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is a prospective cohort study aiming to evaluate an improved VPIA remifentanil algorithm which would benefit labouring mothers who are unable or unwilling to receive epidural analgesia

Detailed description: This study trials a new Vital signs-controlled patient-assisted intravenous analgesia (VPIA) regimen using a purpose-built pump that aims to enhance the efficacy, safety and personalization of remifentanil therapy for labouring women. The system studies the parturient's pattern of analgesic use in 15 minute epochs and titrates 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 pump and step down doses accordingly when predefined critical values are reached.

Eligibility criteria: Inclusion Criteria:

* Patients who choose to use parenteral opioid for pain relief with informed consent
* Patients who refuse labour epidural analgesia or with contraindication to epidural analgesia (eg. thrombocytopaenia, previous thoraco-lumbar spinal instrumentation)
* Gestational age of \>= 36 weeks

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 analogue
* Patients with severe respiratory disease
* Patients with history of drug dependence of recreational drug abuse
* Patients with unmanaged foetal bradycardia

Primary outcomes:
measure: Maternal desaturation
timeFrame: Duration of labour
Secondary outcomes:
measure: Maternal bradycardia
timeFrame: Duration of labour, an expected average of 24 hours
measure: Apnoea/hypopnoea
timeFrame: Duration of labour, an expected average of 24 hours
Other outcomes:
measure: Side effects: pruritus
timeFrame: Duration of labour, an expected average of 24 hours
measure: Side effects: nausea vomiting
timeFrame: Duration of labour, an expected average of 24 hours
measure: Side effects: sedation
timeFrame: Duration of labour, an expected average of 24 hours
measure: Maternal outcomes: duration of labour
timeFrame: Duration of labour, an expected average of 24 hours
measure: Maternal outcomes: duration of second stage
timeFrame: At delivery, an expected average of 1 hour
measure: Maternal outcomes: pain score
timeFrame: Duration of labour, an expected average of 24 hours
measure: Maternal outcomes: satisfaction score
timeFrame: Duration of labour, an expected average of 24 hours
measure: Neonatal outcomes: birth weight
timeFrame: Immediately after birth
measure: Neonatal outcomes: APGAR
timeFrame: Immediately after birth
measure: Neonatal outcomes: cord blood pH
timeFrame: Immediately after birth
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: KK Women's and Children's Hospital
name: Wan Ling Leong, MBBS FANZCA
role: PRINCIPAL_INVESTIGATOR
References: