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

Labor Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02733835
• Other study ID #: CIRB/2015/2352
• Status: Recruiting
• Phase: Phase 4
• First received: December 30, 2015
• Last updated: February 5, 2017
• Start date: December 2016
• Est. completion date: March 2018

Study information

• Verified date: January 2017
• Source: KK Women's and Children's Hospital
• Contact: Wan Ling Leong, MBBS FANZCA
• Phone: +6563941081
• Email: leong.wan.ling[@]singhealth.com.sg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: March 2018
• Est. primary completion date: December 2017
• 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 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

Related Conditions & MeSH terms

• Labor Pain

Intervention

Drug:
• Remifentanil
Vital signs-controlled, patient assisted intravenous analgesia using remifentanil

Locations

Country	Name	City	State
Singapore	KK Women's and 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	Side effects: pruritus	Pruritus	Duration of labour, an expected average of 24 hours
Other	Side effects: nausea vomiting	Nausea/vomiting	Duration of labour, an expected average of 24 hours
Other	Side effects: sedation	Sedation	Duration of labour, an expected average of 24 hours
Other	Maternal outcomes: duration of labour	Duration of labour (minutes)	Duration of labour, an expected average of 24 hours
Other	Maternal outcomes: duration of second stage	Duration of second stage (minutes)	At delivery, an expected average of 1 hour
Other	Maternal outcomes: pain score	Maternal pain score (out of 10)	Duration of labour, an expected average of 24 hours
Other	Maternal outcomes: satisfaction score	Maternal satisfaction score (%)	Duration of labour, an expected average of 24 hours
Other	Neonatal outcomes: birth weight	Birth weight in grams	Immediately after birth
Other	Neonatal outcomes: APGAR	APGAR scores	Immediately after birth
Other	Neonatal outcomes: cord blood pH	Umbilical cord blood pH	Immediately after birth
Primary	Maternal desaturation		Duration of labour
Secondary	Maternal bradycardia		Duration of labour, an expected average of 24 hours
Secondary	Apnoea/hypopnoea		Duration of labour, an expected average of 24 hours