Programmed Intermittent Epidural Bolus Compared With Continuous Infusion in Multiparous Women

NCT ID: NCT06580327

Last Updated: 2025-04-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-25
• Study Completion Date: 2026-03-31

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.

Conditions

Breakthrough Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

study group

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.

Group Type: ACTIVE_COMPARATOR

programmed intermittent Bolus epidural analgesia

Intervention Type: 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.

control group

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.

Group Type: ACTIVE_COMPARATOR

continuous epidural infusion

Intervention Type: 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.

Interventions

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 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.

Intervention Type: 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 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.

Intervention Type: DRUG

Other Intervention Names

Bupivacaine + Fentanyl; Bupivacaine + Fentanyl

Eligibility Criteria

Inclusion Criteria

1. multiparous women

2. Term pregnancy

3. Singleton

4. Vertex presentation

5. Latent phase (cervical dilatation less than 6 cm)

6. Epidural analgesia request

7. Visual Analogue Scale score greater than 40

Exclusion Criteria

1. Estimated fetal weight greater than 4.0 kg

2. Intra uterine fetal death

3. Drug sensitivity

5. Anomalous fetus 6. Contraindication for epidural analgesia

• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Holy Family Hospital, Nazareth, Israel

OTHER

Sponsor Role: lead

Responsible Party

Raed Salim, MD

head of obstetrics and gynecology department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Raed Salim, MD

Role: STUDY_CHAIR

Holy Family Hospital, Nazareth, Israel

Locations

Holy Family Hospital

Nazareth, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Raed Salim, MD

Role: CONTACT

r.salim@hfhosp.org

0544986960 ext. +972

Asmaa Masri Esmail, MD

Role: CONTACT

Asmaa.Masri94@gmail.com

Facility Contacts

Raed Salim, MD

Role: primary

r.salim@hfhosp.org

0544986960

Other Identifiers

298\2024 HFH

Identifier Type: -

Identifier Source: org_study_id