Labor PainVPIANCT02122705
A Case Series of VPIA Using Remifentanil for Labour and Delivery
An observational study of Labor Pain, run by KK Women's and Children's Hospital at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Labor Pain
- What is being tested?
- VPIA remifentanil
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 29 participants
- Where
- 1 siteSingapore
- Study dates
- May 2012to Jun 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Term parturients presenting to the hospital delivery suite in labour
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Case Series of Vital Signs-controlled, Patient Assisted Intravenous Analgesia (VPIA) Using Remifentanil for Labour and Delivery
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.
Read the detailed 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.
- Conditions
- Labor Pain
- Being tested
- VPIA remifentanil
- Keywords
- Remifentanil, Labour analgesia
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VPIA remifentanilDevice
Vital signs controlled patient assisted intravenous analgesia using remifentanil
| Study group | Role | What they receive |
|---|---|---|
| VPIA remifentanil | VPIA remifentanil labour analgesia Receives: Device: VPIA remifentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score
Hourly maternal pain scores
Measured: Duration of labour
Secondary outcomes (3)
Remifentanil drug consumption
Total and hourly remifentanil drug consumption.
Measured: Duration of labour
Maternal side effects
Incidence of side effects : sedation, respiratory depression, oxygen desaturation, bradycardia, pruritus, nausea and vomiting
Measured: Duration of labour and 1st day post delivery
Maternal outcomes
Mode of delivery Duration of second stage Overall satisfaction with labour analgesia
Measured: Duration of labour and one day post delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2014 (estimated)
- Study startMay 2012
- Primary completionJan 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies of the same condition, open and under way.
- More trials run by KK Women's and Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- KK Women's and Children's Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Wan Ling Leong, MBBS FANZCA, Principal investigator, KK Women's & Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02122705
- Sponsor's protocol ID
- CIRB/2012/264/D
- Acronym
- VPIA
- Status last verified
- Sep 2015
- First submitted
- 23 Apr 2014
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case Series of Vital Signs-controlled, Patient Assisted Intravenous Analgesia (VPIA) Using Remifentanil for Labour and Delivery
- ClinicalTrials.gov ID
- NCT02122705
- Acronym / sponsor ID
- VPIA / CIRB/2012/264/D
- Conditions
- Labor Pain
- Keywords
- Remifentanil, Labour analgesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- KK Women's and Children's HospitalOther government
- Study start
- May 2012
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 24 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VPIA remifentanil | – | Device: VPIA remifentanilVPIA remifentanil labour analgesia |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Term parturients presenting to the hospital delivery suite in labour
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VPIA remifentanilVital signs controlled patient assisted intravenous analgesia using remifentanil | Device | VPIA remifentanil |
Primary outcome
Pain score
Time frame: Duration of labour
Hourly maternal pain scores
3 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wan Ling Leong, MBBS FANZCA principal investigator
KK Women's & Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Labor Pain, run by KK Women's and Children's Hospital at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score (time frame: Duration of labour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2017.