A Novel Approach to Optimize Programmed Intermittent Epidural Bolus (PIEB) Delivery for Labour An… (NCT03871530) | Clinical Trial Compass
CompletedNot Applicable
A Novel Approach to Optimize Programmed Intermittent Epidural Bolus (PIEB) Delivery for Labour Analgesia
Canada55 participantsStarted 2019-04-29
Plain-language 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. 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.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* 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
* a physical or psychiatric condition which may impair cooperation
* known fetal anomalies/intrauterine fetal demise
* height \< 5'0"
* Body Mass Index \> 45 kg/m2
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Maternal satisfaction score
Timeframe: 24 hours following delivery
2
Number of clinician administered rescue boluses
Timeframe: Start of labour epidural to delivery time
3
Ratio of the number of PCEA boluses requested to the number of PCEA boluses delivered
Timeframe: Start of labour epidural to delivery time