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AzTrials

Labor PainNCT03871530

A Novel Approach to Optimize Programmed Intermittent Epidural Bolus (PIEB) Delivery for Labour Analgesia

A study testing Coordinate A, Coordinate B and Coordinate C in people with Labor Pain, run by IWK Health Centre at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Programmed intermittent epidural bolus (PIEB) for labour analgesia allows an epidural pump to be programmed to deliver small amounts of the local anesthetic and opioid solution at regularly timed intervals. However, little evidence is available to guide optimal settings for PIEB. 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?
Coordinate A, Coordinate B and Coordinate C
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
1 siteCanada
Study dates
29 Apr 2019to 30 Jun 2022
Phase
Interventional
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

Who may be able to join

  • Nulliparous,
  • English speaking
  • 18-45 years
  • single gestation ≥ 37 weeks
  • vertex presentation
  • American Society of Anesthesiologists (ASA) Physical Status II (mild and controlled systemic disease and/or pregnancy)
  • requesting an epidural for labour analgesia
  • cervical dilation ≤ 7 cm at the time of initiation of epidural analgesia.

Who cannot join

  • Preeclampsia or HELLP syndrome
  • maternal cardiac disease
  • severe or uncontrolled maternal systemic disease
  • contraindication to neuraxial analgesia (i.e. coagulopathy, infection, neuropathy)
  • abnormal spinal anatomy (i.e. severe scoliosis, spina bifida, spinal instrumentation)
  • chronic analgesic use
Show all 10Show fewer
  • a physical or psychiatric condition which may impair cooperation
  • known fetal anomalies/intrauterine fetal demise
  • height < 5'0"
  • Body Mass Index > 45 kg/m2

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • IWK Health Centre

    Halifax, Nova Scotia, B3K 6R8

Other trials in Canada

About this study

Programmed intermittent epidural bolus (PIEB) for labour analgesia allows an epidural pump to be programmed to deliver small amounts of the local anesthetic and opioid solution at regularly timed intervals. However, little evidence is available to guide optimal settings for PIEB. The gaps in evidence include: (1) programmed timing for the first PIEB bolus (referred to as the "NEXT bolus") (2) determination of PIEB bolus volume (3) the interval for subsequent doses (PIEB interval). Response Surface Methodology will be utilized to best estimate the optimal PIEB settings (NEXT bolus interval, PIEB interval time, PIEB volume) by using the following clinical primary outcome measures: maternal satisfaction score, need for a clinician administered rescue bolus, and the ratio of PCEA boluses requested/delivered.

Conditions
Labor Pain
Being tested
Coordinate A, Coordinate B, Coordinate C, Coordinate D, Coordinate E
Keywords
Analgesia, Epidural, Labor, Obstetric Analgesia, Obstetrical
Medical subject headings
Labor Pain, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Coordinate AOther

    PIEB "Next Bolus": 45 minutes, PIEB Interval: 50 minutes, and PIEB volume: 5 mL

  • Coordinate BOther

    PIEB "Next Bolus": 45 minutes, PIEB Interval: 40 minutes, and PIEB volume: 6.5 mL

  • Coordinate COther

    PIEB "Next Bolus": 45 minutes, PIEB Interval: 50 minutes, and PIEB volume: 8 mL

  • Coordinate DOther

    PIEB "Next Bolus": 45 minutes, PIEB Interval: 60 minutes, and PIEB volume: 6.5 mL

  • Coordinate EOther

    PIEB "Next Bolus": 30 minutes, PIEB Interval: 40 minutes, and PIEB volume: 5 mL

  • Coordinate FOther

    PIEB "Next Bolus": 30 minutes, PIEB Interval: 40 minutes, and PIEB volume: 8 mL

  • Coordinate GOther

    PIEB "Next Bolus": 30 minutes, PIEB Interval: 60 minutes, and PIEB volume: 8 mL

  • Coordinate HOther

    PIEB "Next Bolus": 30 minutes, PIEB Interval: 60 minutes, and PIEB volume: 5 mL

  • Coordinate IOther

    PIEB "Next Bolus": 15 minutes, PIEB Interval: 50 minutes, and PIEB volume: 5 mL

  • Coordinate JOther

    PIEB "Next Bolus": 15 minutes, PIEB Interval: 40 minutes, and PIEB volume: 6.5 mL

  • Coordinate KOther

    PIEB "Next Bolus": 15 minutes, PIEB Interval: 50 minutes, and PIEB volume: 8 mL

  • Coordinate LOther

    PIEB "Next Bolus": 15 minutes, PIEB Interval: 60 minutes, and PIEB volume: 6.5 mL

  • Coordinate MOther

    PIEB "Next Bolus": 30 minutes, PIEB Interval: 50 minutes, and PIEB volume: 6.5 mL

  • Coordinate NOther

    PIEB "Next Bolus": 30 minutes, PIEB Interval: 50 minutes, and PIEB volume: 6.5 mL

Study groups in NCT03871530
Study groupRoleWhat they receive
Coordinate AExperimentalPIEB "Next Bolus": 45 minutes, PIEB Interval: 50 minutes, and PIEB volume: 5 mL
Receives: Other: Coordinate A
Coordinate BExperimentalPIEB "Next Bolus": 45 minutes, PIEB Interval: 40 minutes, and PIEB volume: 6.5 mL
Receives: Other: Coordinate B
Coordinate CExperimentalPIEB "Next Bolus": 45 minutes, PIEB Interval: 50 minutes, and PIEB volume: 8 mL
Receives: Other: Coordinate C
Coordinate DExperimentalPIEB "Next Bolus": 45 minutes, PIEB Interval: 60 minutes, and PIEB volume: 6.5 mL
Receives: Other: Coordinate D
Coordinate EExperimentalPIEB "Next Bolus": 30 minutes, PIEB Interval: 40 minutes, and PIEB volume: 5 mL
Receives: Other: Coordinate E
Coordinate FExperimentalPIEB "Next Bolus": 30 minutes, PIEB Interval: 40 minutes, and PIEB volume: 8 mL
Receives: Other: Coordinate F
Coordinate GExperimentalPIEB "Next Bolus": 30 minutes, PIEB Interval: 60 minutes, and PIEB volume: 8 mL
Receives: Other: Coordinate G
Coordinate HExperimentalPIEB "Next Bolus": 30 minutes, PIEB Interval: 60 minutes, and PIEB volume: 5 mL
Receives: Other: Coordinate H
Coordinate IExperimentalPIEB "Next Bolus": 15 minutes, PIEB Interval: 50 minutes, and PIEB volume: 5 mL
Receives: Other: Coordinate I
Coordinate JExperimentalPIEB "Next Bolus": 15 minutes, PIEB Interval: 40 minutes, and PIEB volume: 6.5 mL
Receives: Other: Coordinate J
Coordinate KExperimentalPIEB "Next Bolus": 15 minutes, PIEB Interval: 50 minutes, and PIEB volume: 8 mL
Receives: Other: Coordinate K
Coordinate LExperimentalPIEB "Next Bolus": 15 minutes, PIEB Interval: 60 minutes, and PIEB volume: 6.5 mL
Receives: Other: Coordinate L
Coordinate MExperimentalPIEB "Next Bolus": 30 minutes, PIEB Interval: 50 minutes, and PIEB volume: 6.5 mL
Receives: Other: Coordinate M
Coordinate NExperimentalPIEB "Next Bolus": 30 minutes, PIEB Interval: 50 minutes, and PIEB volume: 6.5 mL
Receives: Other: Coordinate N

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Maternal satisfaction score

    quantified as 0-100, where 0 - not satisfied, and 100 - completely satisfied

    Measured: 24 hours following delivery

  2. Number of clinician administered rescue boluses

    Recorded from the Innovian anesthesia database, IntelliSpace Perinatal, or CADD®-Solis Epidural Pump

    Measured: Start of labour epidural to delivery time

  3. Ratio of the number of PCEA boluses requested to the number of PCEA boluses delivered

    Recorded on the CADD®-Solis Epidural Pump during labour and downloaded by research coordinator after delivery

    Measured: Start of labour epidural to delivery time

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2019
  2. Study start29 Apr 2019
  3. Primary completion15 Oct 2020
  4. Study completion30 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
double-blind randomized trial
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03871530
Sponsor's protocol ID
1023951
Status last verified
Sep 2022
First submitted
1 Mar 2019
Last updated
26 Sep 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Munro A, George RB, Andreou P. An Innovative Approach to Determine Programmed Intermittent Epidural Bolus Pump Settings for Labor Analgesia: A Randomized Controlled Trial. Anesth Analg. 2024 Sep 1;139(3):545-554. doi: 10.1213/ANE.0000000000006813. Epub 2024 Aug 16.

    PubMed 38905148

Questions about this trial

What is this clinical trial studying?

A study testing Coordinate A, Coordinate B and Coordinate C in people with Labor Pain, run by IWK Health Centre at 1 site in Canada.

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 8 inclusion and 10 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 26 Sep 2022. 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 Canada. 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?

Maternal satisfaction score (time frame: 24 hours following delivery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03871530, which also lists 1 linked publication.

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 26 Sep 2022.

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