NCT06580327

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
186

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Sep 2024

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress74%
Sep 2024Dec 2026

First Submitted

Initial submission to the registry

August 26, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 30, 2024

Completed
26 days until next milestone

Study Start

First participant enrolled

September 25, 2024

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

2.1 years

First QC Date

August 26, 2024

Last Update Submit

April 7, 2026

Conditions

Breakthrough Pain

Keywords

multiparaTerm pregnancySingletonVertex presentationLatent phaseMaternal request for epiduralVisual analogue scale > 4

Outcome Measures

Primary Outcomes (1)

  • 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).

    48 hours

Secondary Outcomes (26)

  • manual bolus (top up)

    48 hours

  • Hourly visual analogue scale

    48 hours

  • Time to delivery

    48 hours

  • Oxytocin augmentation

    48 hours

  • Duration of second stage

    48 hours

  • +21 more secondary outcomes

Study Arms (2)

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.

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.

Drug: continuous epidural infusion

Interventions

programmed intermittent Bolus epidural analgesiaDRUG

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
study group
continuous epidural infusionDRUG

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
control group

Eligibility Criteria

Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Estimated fetal weight greater than 4.0 kg
  • Intra uterine fetal death
  • Drug sensitivity
  • \. Anomalous fetus 6. Contraindication for epidural analgesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Holy Family Hospital

Nazareth, 1641100, Israel

RECRUITING

MeSH Terms

Conditions

Breakthrough Pain

Interventions

BupivacaineFentanyl

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Raed Salim, MD

    Holy Family Hospital, Nazareth, Israel

    STUDY CHAIR

Central Study Contacts

Raed Salim, MD

CONTACT

0544986960r.salim@hfhosp.org

Asmaa Masri Esmail, MD

CONTACT

Asmaa.Masri94@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
head of obstetrics and gynecology department

Study Record Dates

First Submitted

August 26, 2024

First Posted

August 30, 2024

Study Start

September 25, 2024

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

IPD that underlie results in a publication

Shared Documents
STUDY PROTOCOL, SAP, CSR
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

Locations

IL(1)