PIEB Compared With CEI on Breakthrough Pain in Multiparous Women

Not Applicable

Recruiting

• Conditions: Breakthrough Pain
• Interventions: Drug: programmed intermittent Bolus epidural analgesia; Drug: continuous epidural infusion

• Registration Number: NCT06580327
• Lead Sponsor: Holy Family Hospital, Nazareth, Israel

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 multiparous women compared to continuous epidural infusion.

multiparous 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.

Study Timeline

• Study First Submitted: 2024-08-26
• Study First Submitted QC: 2024-08-26
• Study First Posted: 2024-08-30
• Study Start: 2024-09-25
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-18
• Last Update Posted: 2025-04-20
• Primary Completion: 2025-12
• Study Completion: 2026-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 186

Inclusion Criteria

multiparous 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group	programmed intermittent Bolus epidural analgesia	Epidural analgesia will be maintained by receiving programmed intermittent 10ml bolus of 0.1% Bupivacaine and 2microgram\\ml Fentanyl every one hour, until the delivery is completed, and lacerations are sutured.
control group	continuous epidural infusion	Epidural analgesia will be maintained by receiving 10ml\\h continuous infusion of 0.1% Bupivacaine and 2microgram\\ml Fentanyl until the delivery is completed, and lacerations are sutured.

Primary Outcome Measures

Name	Time	Method
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).

Secondary Outcome Measures

Name	Time	Method
manual bolus (top up)	48 hours	Number of participants who will require top up of Bupivacaine and Fentanyl due to breakthrough pain.
Hourly visual analogue scale	48 hours	Hourly pain according to visual analogue scale (VAS) score. The VAS consists of a 100cm line, with two end points representing score 0 (no pain) and score 100 (severe pain).
Time to delivery	48 hours	Time from epidural analgesia to delivery.
Oxytocin augmentation	48 hours	Incidence of women who will require Oxytocin for labor augmentation
Duration of second stage	48 hours	The time from complete cervical dilatation until delivery of the fetus (minutes)
Intrapartum fever	48 hours	Number of patients that will have intrapartum fever ≥ 38 °C
Number of patients that will require use of intrapartum use of antibiotic treatment	48 hours	Number of patients that will require use of intrapartum use of antibiotic treatment due to intrapartum infection.
Mode of delivery	48 hours	Whether the birth was a normal spontaneous birth, operative vaginal birth or a cesarean section.
Indications for cesarean or operative vaginal deliveries	48 hours	Was the reason for operative vaginal delivery or cesarean delivery due to non-progressive labor, fetal status, or a combination of both?
duration of third stage	48 hours	time from delivery of the fetus the delivery of the placenta (minutes)
Early postpartum hemorrhage (PPH)	48 hours	Number of Participants with develop PPH
Hemoglobin level	96 hours	The lowest postpartum Hemoglobin level
Blood transfusion	72 hours	Number of Participants that will need blood transfusion.
Obstetric anal sphincter injury	48 hours	Number of Participants with that will develop 3rd and 4th degrees perineal lacerations.
Motor block of any leg	48 hours	Incidence of motor block will be assessed according to Bromage score: Bromage 0 = No motor block. Bromage 1 = the participant is unable to flex her hip Bromage 2 = the participant is able to flex her ankle but unable to flex her hip and knee Bromage 3 = the participant is unable to flex her hip, knee and ankle
Urinary retention	48 hours	Participant will not be able to urinate spontaneously 6 hours after delivery
Dural puncture	48 hours	Incidence of dural puncture during performing epidural analgesia
Side effects related epidural analgesia use	48 hours	nausea, vomiting, and pruritis
mean arterial blood pressure	48 hours	mean arterial blood pressure (mmHg) of the participant during labor
systolic blood pressure < 90mmHg	48 hours	incidence of systolic blood pressure \< 90 during labor
Bupivacaine consumption	48 hours	total Bupivacaine consumption during labor (ml)
maternal satisfaction	48 hours	participant satisfaction from labor experience from 1 to 10.; 1= very dissatisfied 10 = very satisfied
fetal cord artery pH	48 hours	Cord artery pH \<7.1
meconium staining	48 hours	Incidence of meconium-stained amniotic fluid before delivery of the fetus
Neonatal sepsis	72 hours	Incidence of early neonatal sepsis
Apgar score (0 to 10)	48 hours	APGAR score \&lt; 7 after 1 and 5 minutes where lower scores mean a worse outcome.

Trial Locations

Locations (1)

Holy Family Hospital; 🇮🇱 Nazareth, Israel