Labor Pain
Conditions
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.
Interventions
DRUGRemifentanil
Vital signs-controlled, patient assisted intravenous analgesia using remifentanil
Sponsors
KK Women's and Children's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Maternal desaturation | Duration of labour |
Secondary
| Measure | Time frame |
|---|---|
| Maternal bradycardia | Duration of labour, an expected average of 24 hours |
| Apnoea/hypopnoea | Duration of labour, an expected average of 24 hours |
Other
| Measure | Time frame | Description |
|---|---|---|
| Maternal outcomes: duration of labour | Duration of labour, an expected average of 24 hours | Duration of labour (minutes) |
| Maternal outcomes: duration of second stage | At delivery, an expected average of 1 hour | Duration of second stage (minutes) |
| Maternal outcomes: pain score | Duration of labour, an expected average of 24 hours | Maternal pain score (out of 10) |
| Side effects: pruritus | Duration of labour, an expected average of 24 hours | Pruritus |
| Neonatal outcomes: birth weight | Immediately after birth | Birth weight in grams |
| Neonatal outcomes: APGAR | Immediately after birth | APGAR scores |
| Neonatal outcomes: cord blood pH | Immediately after birth | Umbilical cord blood pH |
| Maternal outcomes: satisfaction score | Duration of labour, an expected average of 24 hours | Maternal satisfaction score (%) |
| Side effects: nausea vomiting | Duration of labour, an expected average of 24 hours | Nausea/vomiting |
| Side effects: sedation | Duration of labour, an expected average of 24 hours | Sedation |
Countries
Singapore
Contacts
Primary ContactWan Ling Leong, MBBS FANZCA
Backup ContactBan Leong Sng, MBBS FANZCA
Outcome results
None listed