PIEB Compared With CEI on Breakthrough Pain in Nulliparous Women

Recruiting now · Not applicable

Conditions studied: Breakthrough Pain

In brief

The goal of this randomized controlled trial is to examine the impact of programmed intermittent bolus epidural analgesia technique on the incidence of breakthrough pain during labor in nulliparous women compared to continuous epidural infusion. Nulliparous women will randomly be divided during labor into two groups; study group will receive mix of Bupivacaine and fentanyl once (bolus) every 60 minutes; the control group will receive continuously the same dose during an hour, until delivery.

Key facts

Study ID

NCT06494280

Run by

Holy Family Hospital, Nazareth, Israel

People needed

240

Starts

2024-09-10

Expected to finish

2026-12-01

Last updated by the study team

2026-04-13

Who can join

Age: any. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Nulliparous women
• Term pregnancy
• Singleton
• Vertex presentation
• Latent phase (cervical dilatation <6 cm)
• Epidural analgesia request
• Visual Analogue Scale score > 40

You may not qualify if…

• Estimated fetal weight > 4 kg
• Intra uterine fetal death
• Drug sensitivity
• Anomalous fetus
• Contraindication for epidural analgesia

Where it is running

• Holy Family Hospital — Nazareth, Israel (enrolling)

Full record on ClinicalTrials.gov

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