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PIEB Compared With CEI on Breakthrough Pain in Nulliparous Women

ConditionBreakthrough Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
AgeNot listed
SponsorHoly Family Hospital, Nazareth, Israel

About this 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 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Nulliparous women

Term pregnancy

Singleton

Vertex presentation

Disqualifiers

Estimated fetal weight > 4 kg

Intra uterine fetal death

Drug sensitivity

Anomalous fetus

Trial design

Design model

Parallel

Treatments tested in this trial

  • programmed intermittent Bolus epidural analgesia

    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.

  • continuous epidural infusion

    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.

Treatment groups

240 Participants
are divided into 2 treatment groups
Group A: study groupActive comparator 1 intervention
Group B: control groupActive comparator 1 intervention

Trial outcomes

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).

Time frame
48 hours

Secondary outcomes

1

manual bolus (top up)

Number of participants who will require top up of Bupivacaine and Fentanyl due to breakthrough pain.

Time frame
48 hours
2

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
3

Time to delivery

Time from epidural analgesia to delivery.

Time frame
48 hours
4

Oxytocin augmentation

Incidence of women who will require Oxytocin for labor augmentation

Time frame
48 hours

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Holy Family Hospital, Nazareth, Israel

Lead sponsor

Source ClinicalTrials.gov
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