PIEB Compared With CEI on Breakthrough Pain in Nulliparous Women
NCT Number: NCT06494280
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Breakthrough Pain
Interventions: DRUG: programmed intermittent Bolus epidural analgesia|DRUG: continuous epidural infusion
Sponsor: Holy Family Hospital, Nazareth, Israel
Sex: FEMALE
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 240
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: OTHER
Start Date: 2024-08
Completion Date: 2025-08
Locations: Holy Family Hospital, Nazareth, Israel

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 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.

Primary Outcome Measures: 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 Outcome Measures: manual bolus (top up), Number of participants who will require top up of Bupivacaine and Fentanyl due to breakthrough pain., 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)., 48 hours|Time to delivery, Time from epidural analgesia to delivery., 48 hours|Oxytocin augmentation, Incidence of women who will require Oxytocin for labor augmentation, 48 hours|Duration of second stage, The time from complete cervical dilatation until delivery of the fetus (minutes), 48 hours|Intrapartum fever, Number of patients that will have intrapartum fever ≥ 38 °C, 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., 48 hours|Mode of delivery, Whether the birth was a normal spontaneous birth, operative vaginal birth or a cesarean section., 48 hours|Indications for cesarean or operative vaginal deliveries, Was the reason for operative vaginal delivery or cesarean delivery due to non-progressive labor, fetal status, or a combination of both?, 48 hours|duration of third stage, time from delivery of the fetus the delivery of the placenta (minutes), 48 hours|Early postpartum hemorrhage (PPH), Number of Participants with develop PPH, 48 hours|Hemoglobin level, The lowest postpartum Hemoglobin level, 96 hours|Blood transfusion, Number of Participants that will need blood transfusion., 72 hours|Obstetric anal sphincter injury, Number of Participants with that will develop 3rd and 4th degrees perineal lacerations., 48 hours|Motor block of any leg, Incidence of motor block will be assessed according to Bromage score:

Bromage 0 = No motor block. Bromage 1 = the participant is unable to flex her hip Bromage 2 = the participant is able to flex her ankle but unable to flex her hip and knee Bromage 3 = the participant is unable to flex her hip, knee and ankle, 48 hours|Urinary retention, Participant will not be able to urinate spontaneously 6 hours after delivery, 48 hours|Dural puncture, Incidence of dural puncture during performing epidural analgesia, 48 hours|Side effects related epidural analgesia use, nausea, vomiting, and pruritis, 48 hours|mean arterial blood pressure, mean arterial blood pressure (mmHg) of the participant during labor, 48 hours|systolic blood pressure < 90mmHg, incidence of systolic blood pressure \< 90 during labor, 48 hours|Bupivacaine consumption, total Bupivacaine consumption during labor (ml), 48 hours|maternal satisfaction, participant satisfaction from labor experience from 1 to 10.

1= very dissatisfied 10 = very satisfied, 48 hours|Apgar score (0 to 10), APGAR\< 7 after 1 and 5 minutes where lower scores mean a worse outcome., 48 hours|fetal cord artery pH, Cord artery pH \<7.1, 48 hours|meconium staining, Incidence of meconium-stained amniotic fluid before delivery of the fetus, 48 hours|Neonatal sepsis, Incidence of early neonatal sepsis, 72 hours