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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
5. Anomalous fetus 6. Contraindication for epidural analgesia
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Raed Salim, MD | Contact | 0544986960 | +972 | r.salim@hfhosp.org |
| Asmaa Masri Esmail, MD | Contact | Asmaa.Masri94@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Raed Salim, MD | Holy Family Hospital, Nazareth, Israel | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Holy Family Hospital | Recruiting | Nazareth | 1641100 | Israel |
IPD that underlie results in a publication
starting 6 months after publication
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
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| ID | Term |
|---|---|
| D059390 | Breakthrough Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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|
|
| 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. |
|
|
| 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 |
| 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 |
| Apgar score (0 to 10) | APGAR score < 7 after 1 and 5 minutes where lower scores mean a worse outcome. | 48 hours |
| D000588 |
| Amines |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |