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Impact of Programmed Intermittent Epidural Bolus Compared With Continuous Epidural Infusion on Breakthrough Pain Among Laboring Nulliparous Women. A Randomized Controlled Trial
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.
Details
| Lead sponsor | Holy Family Hospital, Nazareth, Israel |
|---|---|
| Phase | NA |
| Status | RECRUITING |
| Enrolment | 240 |
| Start date | 2024-09-10 |
| Completion | 2026-12 |
Conditions
- Breakthrough Pain
Interventions
- programmed intermittent Bolus epidural analgesia
- continuous epidural infusion
Primary outcomes
- breakthrough pain — 48 hours
Incidence of breakthrough pain, defined as Visual Analogue Scale (VAS) score \> 30. The VAS consists of a 100cm line, with two end points representing 0 ('no pain') and 100 (severe pain).
Countries
Israel