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

Primary Purpose

Labor Pain

Status
Unknown status
Phase
Phase 4
Locations
Singapore
Study Type
Interventional
Intervention
Remifentanil
Sponsored by
KK Women's and Children's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor Pain

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • KK Women's and Children's HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Remifentanil

Arm Description

Remifentanil Patient Controlled Analgesia

Outcomes

Primary Outcome Measures

Maternal desaturation

Secondary Outcome Measures

Maternal bradycardia
Apnoea/hypopnoea

Full Information

First Posted
December 30, 2015
Last Updated
February 5, 2017
Sponsor
KK Women's and Children's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02733835
Brief Title
VPIA Remifentanil for Labour Pain to Reduce Maternal Desaturation and Improve Analgesic Titration
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 2016 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
March 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
KK Women's and Children's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Remifentanil
Arm Type
Experimental
Arm Description
Remifentanil Patient Controlled Analgesia
Intervention Type
Drug
Intervention Name(s)
Remifentanil
Other Intervention Name(s)
Ultiva
Intervention Description
Vital signs-controlled, patient assisted intravenous analgesia using remifentanil
Primary Outcome Measure Information:
Title
Maternal desaturation
Time Frame
Duration of labour
Secondary Outcome Measure Information:
Title
Maternal bradycardia
Time Frame
Duration of labour, an expected average of 24 hours
Title
Apnoea/hypopnoea
Time Frame
Duration of labour, an expected average of 24 hours
Other Pre-specified Outcome Measures:
Title
Side effects: pruritus
Description
Pruritus
Time Frame
Duration of labour, an expected average of 24 hours
Title
Side effects: nausea vomiting
Description
Nausea/vomiting
Time Frame
Duration of labour, an expected average of 24 hours
Title
Side effects: sedation
Description
Sedation
Time Frame
Duration of labour, an expected average of 24 hours
Title
Maternal outcomes: duration of labour
Description
Duration of labour (minutes)
Time Frame
Duration of labour, an expected average of 24 hours
Title
Maternal outcomes: duration of second stage
Description
Duration of second stage (minutes)
Time Frame
At delivery, an expected average of 1 hour
Title
Maternal outcomes: pain score
Description
Maternal pain score (out of 10)
Time Frame
Duration of labour, an expected average of 24 hours
Title
Maternal outcomes: satisfaction score
Description
Maternal satisfaction score (%)
Time Frame
Duration of labour, an expected average of 24 hours
Title
Neonatal outcomes: birth weight
Description
Birth weight in grams
Time Frame
Immediately after birth
Title
Neonatal outcomes: APGAR
Description
APGAR scores
Time Frame
Immediately after birth
Title
Neonatal outcomes: cord blood pH
Description
Umbilical cord blood pH
Time Frame
Immediately after birth

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wan Ling Leong, MBBS FANZCA
Phone
+6563941081
Email
leong.wan.ling@singhealth.com.sg
First Name & Middle Initial & Last Name or Official Title & Degree
Ban Leong Sng, MBBS FANZCA
Phone
+6563941081
Email
sng.ban.leong@singhealth.com.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wan Ling Leong, MBBS FANZCA
Organizational Affiliation
KK Women's and Children's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
KK Women's and Children's Hospital
City
Singapore
ZIP/Postal Code
229899
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wan Ling Leong, MBBS FANZCA
Phone
+6563941081
Email
leong.wan.ling@singhealth.com.sg

12. IPD Sharing Statement

Plan to Share IPD
No

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

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