PIEB Compared With CEI on Breakthrough Pain in Nulliparous Women

Holy Family Hospital, Nazareth, Israel240 enrolled

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 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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

240

Conditions

Breakthrough Pain

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.

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.

Eligibility

Sex: FEMALEHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Nulliparous women * Term pregnancy * Singleton * Vertex presentation * Latent phase (cervical dilatation \<6 cm) * Epidural analgesia request * Visual Analogue Scale score \> 40 Exclusion Criteria: * Estimated fetal weight \> 4 kg * Intra uterine fetal death * Drug sensitivity * Anomalous fetus * Contraindication for epidural analgesia

Locations (1)

Holy Family Hospital

Nazareth, Israel

RECRUITING

Outcomes

Primary Outcomes

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

manual bolus (top up)

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

Time frame: 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).

Time frame: 48 hours

Time to delivery

Time from epidural analgesia to delivery.

Time frame: 48 hours

Oxytocin augmentation

Incidence of women who will require Oxytocin for labor augmentation

Time frame: 48 hours

Duration of second stage

The time from complete cervical dilatation until delivery of the fetus (minutes)

Time frame: 48 hours

Intrapartum fever

Number of patients that will have intrapartum fever ≥ 38 °C

Time frame: 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.

Central Contacts

Raed Salim, MD

CONTACT

+972544986960 r.salim@hfhosp.org

Asmaa Masri Esmail, MD

CONTACT

+972544986960 Asmaa.Masri94@gmail.com

Data from ClinicalTrials.gov

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