Programmed Intermittent Epidural Bolus Compared With Continuous Infusion in Multiparous Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: programmed intermittent Bolus epidural analgesia, continuous epidural infusion.
- Who it may be relevant to
- Registry conditions: Breakthrough Pain. Basic parameters: No limits · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Israel
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Impact of Programmed Intermittent Epidural Bolus Compared With Continuous Epidural Infusion on Breakthrough Pain Among Laboring Multiparous Women. A Randomized Controlled Trial
Overview
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.
Interventions
- Drug programmed intermittent Bolus epidural analgesia
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 - Drug continuous epidural infusion
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 t
Primary outcome measures
- breakthrough pain [Time frame: 48 hours]
Secondary outcome measures (12)
- manual bolus (top up) [Time frame: 48 hours]
- Hourly visual analogue scale [Time frame: 48 hours]
- Time to delivery [Time frame: 48 hours]
- Oxytocin augmentation [Time frame: 48 hours]
- Duration of second stage [Time frame: 48 hours]
- Intrapartum fever [Time frame: 48 hours]
- Number of patients that will require use of intrapartum use of antibiotic treatment [Time frame: 48 hours]
- Mode of delivery [Time frame: 48 hours]
- Indications for cesarean or operative vaginal deliveries [Time frame: 48 hours]
- duration of third stage [Time frame: 48 hours]
- Early postpartum hemorrhage (PPH) [Time frame: 48 hours]
- Hemoglobin level [Time frame: 96 hours]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- Estimated fetal weight greater than 4.0 kg
- Intra uterine fetal death
- Drug sensitivity
5\. Anomalous fetus 6. Contraindication for epidural analgesia
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Other
Study locations
Israel · 1 center
- Holy Family Hospital — Nazareth
Identifiers
NCT: NCT06580327 · 298\2024 HFH