Clinical trial NCT06494280: PIEB Compared With CEI on Breakthrough Pain in Nulliparous Women
Official title: Impact of Programmed Intermittent Epidural Bolus Compared With Continuous Epidural Infusion on Breakthrough Pain Among Laboring Nulliparous Women. A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breakthrough Pain
Keywords: Nullipara
Term pregnancy
Singleton
Vertex presentation
Latent phase
Maternal request for epidural
Visual analogue scale > 4
Lead sponsor: Holy Family Hospital, Nazareth, Israel
Sponsor class: OTHER
First posted: 2024-07-10
Enrollment: 240
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: breakthrough pain
timeFrame: 48 hours
Secondary outcomes:
measure: manual bolus (top up)
timeFrame: 48 hours
measure: Hourly visual analogue scale
timeFrame: 48 hours
measure: Time to delivery
timeFrame: 48 hours
measure: Oxytocin augmentation
timeFrame: 48 hours
measure: Duration of second stage
timeFrame: 48 hours
measure: Intrapartum fever
timeFrame: 48 hours
measure: Number of patients that will require use of intrapartum use of antibiotic treatment.
timeFrame: 48 hours
measure: Mode of delivery
timeFrame: 48 hours
measure: Indications for cesarean or operative vaginal deliveries
timeFrame: 48 hours
measure: duration of third stage
timeFrame: 48 hours
measure: Early postpartum hemorrhage (PPH)
timeFrame: 48 hours
measure: Hemoglobin level
timeFrame: 96 hours
measure: Blood transfusion
timeFrame: 72 hours
measure: Obstetric anal sphincter injury
timeFrame: 48 hours
measure: Motor block of any leg
timeFrame: 48 hours
measure: Urinary retention
timeFrame: 48 hours
measure: Dural puncture
timeFrame: 48 hours
measure: Side effects related epidural analgesia use
timeFrame: 48 hours
measure: mean arterial blood pressure
timeFrame: 48 hours
measure: systolic blood pressure < 90mmHg
timeFrame: 48 hours
measure: Bupivacaine consumption
timeFrame: 48 hours
measure: maternal satisfaction
timeFrame: 48 hours
measure: Apgar score (0 to 10)
timeFrame: 48 hours
measure: fetal cord artery pH
timeFrame: 48 hours
measure: meconium staining
timeFrame: 48 hours
measure: Neonatal sepsis
timeFrame: 72 hours
Other outcomes:
Locations:
city: Nazareth
country: Israel
facility: Holy Family Hospital
Study officials:
affiliation: Holy Family Hospital, Nazareth, Israel
name: Raed Salim, MD
role: STUDY_CHAIR
References:
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