UnknownNot Applicable

Programmed Intermittent Epidural Bolus Versus Continuous Infusion in Labour Analgesia

Canada200 participantsStarted 2019-06-01

Plain-language summary

This study aims to establish if programmed intermittent epidural bolus combined to patient controlled analgesia in labour analgesia will lower the hourly bupivacaine consumption when compared to continuous infusion combined with patient controlled analgesia. The investigators' hypothesis is that the use of programmed intermittent epidural bolus will lower the hourly bupivacaine consumption.

Who can participate

Age range

18 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: * Pregnant nulliparous or multiparous woman in labour * Age ≥18 years * Obtained consent for epidural analgesia * ASA classification I-II-III * Early labour (cervical dilation ≤6cm) Exclusion Criteria: * Pregnancy-related comorbidities (preeclampsia, eclampsia, gestational diabetes, large for gestational age fetus) * Prematurity (\<36 weeks of gestation) * Multiple gestation * Fentanyl allergy or hypersensitivity * Patient unable to understand the PCEA * Fetal breech position * Maternal cardiac pathology and contraindication to Valsalva manoeuvre * Patient with a pain visual analog scale (VAS) not ≤1/10 20 minutes after the anesthesiologist's initial bolus * Intrathecal catheter or intravascular catheter * Accidental dural puncture * Patient refusal * Patient with a history of chronic pain (pain lasting more than 3 months) or fibromyalgia

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

Dose of bupivacaine in milligrams per hour

Timeframe: 1 day

Trial details

NCT IDNCT03730753

SponsorUniversité de Sherbrooke

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-06-30

Contact for this trial

Isabelle Caron, Dr.

+1 819 346-1110 isabelle.caron4@usherbrooke.ca

View on ClinicalTrials.gov More Labor Pain trials