A Case Series of VPIA Using Remifentanil for Labour and Delivery

Labor Pain Clinical Trial

— VPIA  

Official title:

A Case Series of Vital Signs-controlled, Patient Assisted Intravenous Analgesia (VPIA) Using Remifentanil for Labour and Delivery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02122705
• Other study ID #: CIRB/2012/264/D
• Status: Completed
• Phase: N/A
• First received: April 23, 2014
• Last updated: February 5, 2017
• Start date: May 2012
• Est. completion date: June 2016

Study information

• Verified date: September 2015
• Source: KK Women's and Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: June 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Labor Pain

Intervention

Device:
• VPIA remifentanil
Vital signs controlled patient assisted intravenous analgesia using remifentanil

Locations

Country	Name	City	State
Singapore	KK Women's & Children's Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
KK Women's and Children's Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Neonatal outcomes	Birth weight APGAR scores at 1 and 5 minutes umbilical cord blood pH	Duration of labour and one day post delivery
Primary	Pain score	Hourly maternal pain scores	Duration of labour
Secondary	Remifentanil drug consumption	Total and hourly remifentanil drug consumption.	Duration of labour
Secondary	Maternal side effects	Incidence of side effects : sedation, respiratory depression, oxygen desaturation, bradycardia, pruritus, nausea and vomiting	Duration of labour and 1st day post delivery
Secondary	Maternal outcomes	Mode of delivery Duration of second stage Overall satisfaction with labour analgesia	Duration of labour and one day post delivery