PIEB Compared With CEI on Breakthrough Pain in Nulliparous Women

Last updated: April 18, 2025
Sponsor: Holy Family Hospital, Nazareth, Israel
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

programmed intermittent Bolus epidural analgesia

continuous epidural infusion

Clinical Study ID

NCT06494280
297\2024 HFH
  • Female
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Nulliparous women

  • Term pregnancy

  • Singleton

  • Vertex presentation

  • Latent phase (cervical dilatation <6 cm)

  • Epidural analgesia request

  • Visual Analogue Scale score > 40

Exclusion

Exclusion Criteria:

  • Estimated fetal weight > 4 kg

  • Intra uterine fetal death

  • Drug sensitivity

  • Anomalous fetus

  • Contraindication for epidural analgesia

Study Design

Total Participants: 240
Treatment Group(s): 2
Primary Treatment: programmed intermittent Bolus epidural analgesia
Phase:
Study Start date:
September 10, 2024
Estimated Completion Date:
March 31, 2026

Study Description

There are several pharmacological and non-pharmacological techniques for pain relief during labor. Epidural analgesia is considered the most effective modality for intrapartum pain relief.

Maintenance of epidural analgesia is achieved by different techniques; continuous epidural infusion (CEI), intermittent epidural analgesia (IEA), patient control epidural analgesia (PCEA) and combination between the techniques.

Another technique, the Programmed Intermittent Bolus Epidural Analgesia (PIBEA). The advantage of this technique is that boluses are given all the time at planned intervals, so laboring women do not depend on the medical staff to receive the bolus when there is a breakthrough pain.

This method has been reported to be associated with less motor block, lower incidence of instrumental vaginal deliveries, and less consumption of anesthetic agents when compared to CEI. There are no conclusive data regarding the use of PIBEA in combination with PCEA compared to CEI and PCEA on the effect of pain relief during labor and birth outcomes. The hypothesis of the current trial is that PIBEA and PCEA will decrease the incidence of breakthrough pain, and probably shorten the second stage of labor, lead to fewer instrumental deliveries and higher women's satisfaction compared to CEI and PCEA.

Connect with a study center

  • Holy Family Hospital

    Nazareth,
    Israel

    Active - Recruiting

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