VPIA Remifentanil for Labour Pain to Reduce Maternal Desaturation and Improve Analgesic Titration

Novel Vital-sign Patient-assisted Intravenous Analgesia With Remifentanil for Labour Pain to Reduce Maternal Desaturation and Improve Analgesic Titration: a Prospective Cohort Study

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

Study Overview

• Status: Unknown
• Conditions: Labor Pain
• Intervention / Treatment: Drug: Remifentanil

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.

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Wan Ling Leong, MBBS FANZCA; Phone Number: +6563941081; Email: leong.wan.ling@singhealth.com.sg
• Study Contact Backup: Name: Ban Leong Sng, MBBS FANZCA; Phone Number: +6563941081; Email: sng.ban.leong@singhealth.com.sg

Study Locations

• Singapore
  • Singapore, Singapore, 229899
    • Recruiting
    • KK Women's and Children's Hospital
    • Contact: Wan Ling Leong, MBBS FANZCA; Phone Number: +6563941081; Email: leong.wan.ling@singhealth.com.sg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Remifentanil; Remifentanil Patient Controlled Analgesia	Drug: Remifentanil; Vital signs-controlled, patient assisted intravenous analgesia using remifentanil; Other Names: Ultiva

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Maternal desaturation	Duration of labour

Secondary Outcome Measures

Outcome 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Side effects: pruritus	Pruritus	Duration of labour, an expected average of 24 hours
Side effects: nausea vomiting	Nausea/vomiting	Duration of labour, an expected average of 24 hours
Side effects: sedation	Sedation	Duration of labour, an expected average of 24 hours
Maternal outcomes: duration of labour	Duration of labour (minutes)	Duration of labour, an expected average of 24 hours
Maternal outcomes: duration of second stage	Duration of second stage (minutes)	At delivery, an expected average of 1 hour
Maternal outcomes: pain score	Maternal pain score (out of 10)	Duration of labour, an expected average of 24 hours
Maternal outcomes: satisfaction score	Maternal satisfaction score (%)	Duration of labour, an expected average of 24 hours
Neonatal outcomes: birth weight	Birth weight in grams	Immediately after birth
Neonatal outcomes: APGAR	APGAR scores	Immediately after birth
Neonatal outcomes: cord blood pH	Umbilical cord blood pH	Immediately after birth

Collaborators and Investigators

• Sponsor: KK Women's and Children's Hospital
• Investigators: Principal Investigator: Wan Ling Leong, MBBS FANZCA, KK Women's and Children's Hospital

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): March 1, 2018

Study Registration Dates

• First Submitted: December 30, 2015
• First Submitted That Met QC Criteria: April 5, 2016
• First Posted (Estimate): April 12, 2016

Study Record Updates

• Last Update Posted (Estimate): February 7, 2017
• Last Update Submitted That Met QC Criteria: February 5, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Analgesics, Opioid; Narcotics; Remifentanil
• Other Study ID Numbers: CIRB/2015/2352

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO