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NCT Number: NCT06494280

PIEB Compared With CEI on Breakthrough Pain in Nulliparous Women

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.

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Key information

Conditions

Breakthrough Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Holy Family Hospital

Nazareth, Israel

Location status: Recruiting

Location contact

Asmaa Masri Esmail, MD

PRINCIPAL_INVESTIGATOR

Raed Salim, MD

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

programmed intermittent Bolus epidural analgesia

Drug

About 30 minutes after the end of the epidural and administration of the loading dose, the woman will be asked to report her pain level. If the VAS score <30, the woman will receive the study group protocol for pain maintenance, i.e., a programmed intermittent bolus of 10 ml of 0.1% bupivacaine and 2 μg/ml fentanyl every hour until the completion of labor and suturing of the incision. The participant can add to herself 5 ml of the same solution of Bupivacaine and Fentanyl every 30 minutes. The maximum dose that the parturient is allowed to receive is 20 ml for one hour.

If a breakthrough pain appears during labor, a bolus of 10 ml of anesthetic solution with the same concentration will be added.

Participants with a VAS score >30 after 30 minutes of the loading dose will be asked to perform a new epidural (if it was decided that the epidural failed) otherwise her data will not be collected for the final analysis of the study.

Other names: Bupivacaine + Fentanyl

continuous epidural infusion

Drug

About 30 minutes after the end of the epidural and administration of the loading dose, the woman will be asked to report her pain level. If the VAS score <30, the woman will receive the control group protocol for pain maintenance, i.e., 0.1% Bupivacaine and 2 μg/ml fentanyl as a continuous infusion per one hour, until the delivery is completed, and laceration is sutured. The participant can add to herself 5 ml of the same solution of Bupivacaine and Fentanyl every 30 minutes. The maximum dose that the parturient is allowed to receive is 20 ml for one hour.

If a breakthrough pain appears during labor, a bolus of 10 ml of anesthetic solution with the same concentration will be added.

Participants with a VAS score >30 after 30 minutes of the loading dose will be asked to perform a new epidural (if it was decided that the epidural failed) otherwise her data will not be collected for the final analysis of the study.

Other names: Bupivacaine + Fentanyl

Primary outcomes

  1. breakthrough pain

    Time frame: 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 outcomes

  1. manual bolus (top up)

    Time frame: 48 hours

    Number of participants who will require top up of Bupivacaine and Fentanyl due to breakthrough pain.

  2. Hourly visual analogue scale

    Time frame: 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).

  3. Time to delivery

    Time frame: 48 hours

    Time from epidural analgesia to delivery.

  4. Oxytocin augmentation

    Time frame: 48 hours

    Incidence of women who will require Oxytocin for labor augmentation

  5. Duration of second stage

    Time frame: 48 hours

    The time from complete cervical dilatation until delivery of the fetus (minutes)

  6. Intrapartum fever

    Time frame: 48 hours

    Number of patients that will have intrapartum fever ≥ 38 °C

  7. Number of patients that will require use of intrapartum use of antibiotic treatment.

    Time frame: 48 hours

    Number of patients that will require use of intrapartum use of antibiotic treatment due to intrapartum infection.

  8. Mode of delivery

    Time frame: 48 hours

    Whether the birth was a normal spontaneous birth, operative vaginal birth or a cesarean section.

  9. Indications for cesarean or operative vaginal deliveries

    Time frame: 48 hours

    Was the reason for operative vaginal delivery or cesarean delivery due to non-progressive labor, fetal status, or a combination of both?

  10. duration of third stage

    Time frame: 48 hours

    time from delivery of the fetus the delivery of the placenta (minutes)

  11. Early postpartum hemorrhage (PPH)

    Time frame: 48 hours

    Number of Participants with develop PPH

  12. Hemoglobin level

    Time frame: 96 hours

    The lowest postpartum Hemoglobin level

  13. Blood transfusion

    Time frame: 72 hours

    Number of Participants that will need blood transfusion.

  14. Obstetric anal sphincter injury

    Time frame: 48 hours

    Number of Participants with that will develop 3rd and 4th degrees perineal lacerations.

  15. Motor block of any leg

    Time frame: 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

  16. Urinary retention

    Time frame: 48 hours

    Participant will not be able to urinate spontaneously 6 hours after delivery

  17. Dural puncture

    Time frame: 48 hours

    Incidence of dural puncture during performing epidural analgesia

  18. Side effects related epidural analgesia use

    Time frame: 48 hours

    nausea, vomiting, and pruritis

  19. mean arterial blood pressure

    Time frame: 48 hours

    mean arterial blood pressure (mmHg) of the participant during labor

  20. systolic blood pressure < 90mmHg

    Time frame: 48 hours

    incidence of systolic blood pressure < 90 during labor

  21. Bupivacaine consumption

    Time frame: 48 hours

    total Bupivacaine consumption during labor (ml)

  22. maternal satisfaction

    Time frame: 48 hours

    participant satisfaction from labor experience from 1 to 10.

    1= very dissatisfied 10 = very satisfied

  23. Apgar score (0 to 10)

    Time frame: 48 hours

    APGAR< 7 after 1 and 5 minutes where lower scores mean a worse outcome.

  24. fetal cord artery pH

    Time frame: 48 hours

    Cord artery pH <7.1

  25. meconium staining

    Time frame: 48 hours

    Incidence of meconium-stained amniotic fluid before delivery of the fetus

  26. Neonatal sepsis

    Time frame: 72 hours

    Incidence of early neonatal sepsis

Study contacts

Contact information is provided by the study sponsor or research team.

Asmaa Masri Esmail, MD

CONTACT

[email protected]

+972544986960

Raed Salim, MD

CONTACT

[email protected]

+972544986960

Sponsors and collaborators

Lead sponsor

Holy Family Hospital, Nazareth, Israel

Other

Registry information

Official study title

Impact of Programmed Intermittent Epidural Bolus Compared With Continuous Epidural Infusion on Breakthrough Pain Among Laboring Nulliparous Women. A Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 10, 2024
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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