Breakthrough PainNCT06580327
Programmed Intermittent Epidural Bolus Compared With Continuous Infusion in Multiparous Women
A study testing programmed intermittent Bolus epidural analgesia and continuous epidural infusion in people with Breakthrough Pain, run by Holy Family Hospital, Nazareth, Israel at 1 site in Israel.
Trial 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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breakthrough Pain
- What is being tested?
- programmed intermittent Bolus epidural analgesia and continuous epidural infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 186 participants
- Where
- 1 siteIsrael
- Study dates
- 25 Sep 2024to Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- multiparous women
- Term pregnancy
- Singleton
- Vertex presentation
- Latent phase (cervical dilatation less than 6 cm)
- Epidural analgesia request
- Visual Analogue Scale score greater than 40
Who cannot join
- Estimated fetal weight greater than 4.0 kg
- Intra uterine fetal death
- Drug sensitivity
- 5. Anomalous fetus 6. Contraindication for epidural analgesia
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Asmaa Masri Esmail, MD contact
Israel1 site, 1 recruiting
- Recruiting
Holy Family Hospital
Nazareth, 1641100
Raed Salim, MD, 0544986960, r.salim@hfhosp.org
Asmaa Masri Esmail, M.D.
About this study
Official title: Impact of Programmed Intermittent Epidural Bolus Compared With Continuous Epidural Infusion on Breakthrough Pain Among Laboring Multiparous Women. A Randomized Controlled Trial
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.
Read the 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.
- Conditions
- Breakthrough Pain
- Being tested
- programmed intermittent Bolus epidural analgesia, continuous epidural infusion
- Keywords
- multipara, Term pregnancy, Singleton, Vertex presentation, Latent phase, Maternal request for epidural, Visual analogue scale > 4
- Medical subject headings
- Breakthrough Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
programmed intermittent Bolus epidural analgesiaDrug
Also called 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.
continuous epidural infusionDrug
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| study group | Active comparator | 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. Receives: Drug: programmed intermittent Bolus epidural analgesia |
| control group | Active comparator | 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. Receives: Drug: continuous epidural infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 48 hours
Secondary outcomes (26)
manual bolus (top up)
Number of participants who will require top up of Bupivacaine and Fentanyl due to breakthrough pain.
Measured: 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).
Measured: 48 hours
Time to delivery
Time from epidural analgesia to delivery.
Measured: 48 hours
Oxytocin augmentation
Incidence of women who will require Oxytocin for labor augmentation
Measured: 48 hours
Duration of second stage
The time from complete cervical dilatation until delivery of the fetus (minutes)
Measured: 48 hours
Intrapartum fever
Number of patients that will have intrapartum fever ≥ 38 °C
Measured: 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.
Measured: 48 hours
Mode of delivery
Whether the birth was a normal spontaneous birth, operative vaginal birth or a cesarean section.
Measured: 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?
Measured: 48 hours
duration of third stage
time from delivery of the fetus the delivery of the placenta (minutes)
Measured: 48 hours
Early postpartum hemorrhage (PPH)
Number of Participants with develop PPH
Measured: 48 hours
Hemoglobin level
The lowest postpartum Hemoglobin level
Measured: 96 hours
Blood transfusion
Number of Participants that will need blood transfusion.
Measured: 72 hours
Obstetric anal sphincter injury
Number of Participants with that will develop 3rd and 4th degrees perineal lacerations.
Measured: 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
Measured: 48 hours
Urinary retention
Participant will not be able to urinate spontaneously 6 hours after delivery
Measured: 48 hours
Dural puncture
Incidence of dural puncture during performing epidural analgesia
Measured: 48 hours
Side effects related epidural analgesia use
nausea, vomiting, and pruritis
Measured: 48 hours
mean arterial blood pressure
mean arterial blood pressure (mmHg) of the participant during labor
Measured: 48 hours
systolic blood pressure < 90mmHg
incidence of systolic blood pressure < 90 during labor
Measured: 48 hours
Bupivacaine consumption
total Bupivacaine consumption during labor (ml)
Measured: 48 hours
maternal satisfaction
participant satisfaction from labor experience from 1 to 10.
1= very dissatisfied 10 = very satisfied
Measured: 48 hours
fetal cord artery pH
Cord artery pH <7.1
Measured: 48 hours
meconium staining
Incidence of meconium-stained amniotic fluid before delivery of the fetus
Measured: 48 hours
Neonatal sepsis
Incidence of early neonatal sepsis
Measured: 72 hours
Apgar score (0 to 10)
APGAR score \< 7 after 1 and 5 minutes where lower scores mean a worse outcome.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2024
- Study start25 Sep 2024
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breakthrough PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 186 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Holy Family Hospital, Nazareth, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Raed Salim, MD, Holy Family Hospital, Nazareth, Israel
- Investigators
- Raed Salim, MD, Study chair, Holy Family Hospital, Nazareth, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06580327
- Sponsor's protocol ID
- 298\2024 HFH
- Status last verified
- Apr 2026
- First submitted
- 26 Aug 2024
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD that underlie results in a publication