A Case Series of Vital Signs-controlled, Patient Assisted Intravenous Analgesia (VPIA) Using Remifentanil for Labour and Delivery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 29
- Locations
- 1
- Primary Endpoint
- Pain score
Study Overview
Brief Summary
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
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 Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Pain score
Time Frame: Duration of labour
Hourly maternal pain scores
Secondary Outcomes
- Maternal outcomes(Duration of labour and one day post delivery)
- Maternal side effects(Duration of labour and 1st day post delivery)
- Remifentanil drug consumption(Duration of labour)