This trial is active, not recruiting.

Condition labor pain
Treatment vpia remifentanil
Sponsor KK Women's and Children's Hospital
Start date May 2012
End date June 2016
Trial size 29 participants
Trial identifier NCT02122705, CIRB/2012/264/D


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective
VPIA remifentanil labour analgesia
vpia remifentanil
Vital signs controlled patient assisted intravenous analgesia using remifentanil

Primary Outcomes

Pain score
time frame: Duration of labour

Secondary Outcomes

Remifentanil drug consumption
time frame: Duration of labour
Maternal side effects
time frame: Duration of labour and 1st day post delivery
Maternal outcomes
time frame: Duration of labour and one day post delivery

Eligibility Criteria

Female participants from 18 years up to 45 years old.

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

Additional Information

Official title A Case Series of Vital Signs-controlled, Patient Assisted Intravenous Analgesia (VPIA) Using Remifentanil for Labour and Delivery
Principal investigator Wan Ling Leong, MBBS FANZCA
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2015.
Information provided to ClinicalTrials.gov by KK Women's and Children's Hospital.