An interventional study of programmed intermittent Bolus epidural analgesia and continuous epidural infusion in Breakthrough Pain, sponsored by Holy Family Hospital, Nazareth, Israel. Recruiting at 1 site in Israel. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Holy Family Hospital, Nazareth, Israel · Not applicable, Interventional, and Other
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.
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.
34 studies on the registry are indexed under Breakthrough Pain; 4 are open to participants now.
This study's planned enrollment of 240 is above the median of 91 across 21 interventional studies indexed under Breakthrough Pain.
Browse Breakthrough Pain studies →Holy Family Hospital, Nazareth, Israel is the lead sponsor of 10 studies on the registry; 9 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: programmed intermittent Bolus epidural analgesia
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.
Drug: continuous epidural infusion
Drug pages: Bupivacaine · Fentanyl
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.
Also known as: Bupivacaine + Fentanyl
Drug pages: Bupivacaine · Fentanyl
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.
Also known as: Bupivacaine + Fentanyl
breakthrough pain
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).
Time frame: 48 hours
manual bolus (top up)
Number of participants who will require top up of Bupivacaine and Fentanyl due to breakthrough pain.
Time frame: 48 hours
Hourly visual analogue scale
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 frame: 48 hours
Time to delivery
Time from epidural analgesia to delivery.
Time frame: 48 hours
Oxytocin augmentation
Incidence of women who will require Oxytocin for labor augmentation
Time frame: 48 hours
Duration of second stage
The time from complete cervical dilatation until delivery of the fetus (minutes)
Time frame: 48 hours
Intrapartum fever
Number of patients that will have intrapartum fever ≥ 38 °C
Time frame: 48 hours
Number of patients that will require use of intrapartum use of antibiotic treatment.
Number of patients that will require use of intrapartum use of antibiotic treatment due to intrapartum infection.
Time frame: 48 hours
Mode of delivery
Whether the birth was a normal spontaneous birth, operative vaginal birth or a cesarean section.
Time frame: 48 hours
Indications for cesarean or operative vaginal deliveries
Was the reason for operative vaginal delivery or cesarean delivery due to non-progressive labor, fetal status, or a combination of both?
Time frame: 48 hours
duration of third stage
time from delivery of the fetus the delivery of the placenta (minutes)
Time frame: 48 hours
Early postpartum hemorrhage (PPH)
Number of Participants with develop PPH
Time frame: 48 hours
Hemoglobin level
The lowest postpartum Hemoglobin level
Time frame: 96 hours
Blood transfusion
Number of Participants that will need blood transfusion.
Time frame: 72 hours
Obstetric anal sphincter injury
Number of Participants with that will develop 3rd and 4th degrees perineal lacerations.
Time frame: 48 hours
Motor block of any leg
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
Time frame: 48 hours
Urinary retention
Participant will not be able to urinate spontaneously 6 hours after delivery
Time frame: 48 hours
Dural puncture
Incidence of dural puncture during performing epidural analgesia
Time frame: 48 hours
Side effects related epidural analgesia use
nausea, vomiting, and pruritis
Time frame: 48 hours
mean arterial blood pressure
mean arterial blood pressure (mmHg) of the participant during labor
Time frame: 48 hours
systolic blood pressure < 90mmHg
incidence of systolic blood pressure \< 90 during labor
Time frame: 48 hours
Bupivacaine consumption
total Bupivacaine consumption during labor (ml)
Time frame: 48 hours
maternal satisfaction
participant satisfaction from labor experience from 1 to 10. 1= very dissatisfied 10 = very satisfied
Time frame: 48 hours
Apgar score (0 to 10)
APGAR\< 7 after 1 and 5 minutes where lower scores mean a worse outcome.
Time frame: 48 hours
fetal cord artery pH
Cord artery pH \<7.1
Time frame: 48 hours
meconium staining
Incidence of meconium-stained amniotic fluid before delivery of the fetus
Time frame: 48 hours
Neonatal sepsis
Incidence of early neonatal sepsis
Time frame: 72 hours
Plan to share: Yes — IPD that underlie results in a publication
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: starting 6 months after publication
Access criteria: Access to IPD can be requested by qualified researchers and will be granted after review and approval of a research proposal and statistical analysis plan and execution of a data sharing agreement. For more information or to apply, please contact the Principal Investigator
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Studies of the drugs tested here: Bupivacaine · Fentanyl
Holy Family Hospital, Nazareth, Israel