Ignite Creation Date:
2024-07-17 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06494280
Status:
RECRUITING
Last Update Posted:
2024-07-15
First Post:
2024-07-02
Brief Title:
PIEB Compared With CEI on Breakthrough Pain in Nulliparous Women
Sponsor:
Holy Family Hospital Nazareth Israel
Organization:
Holy Family Hospital Nazareth Israel
Study Overview
Official Title:
Impact of Programmed Intermittent Epidural Bolus Compared With Continuous Epidural Infusion on Breakthrough Pain Among Laboring Nulliparous Women A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
Detailed Description:
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 womens satisfaction compared to CEI and PCEA
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 womens satisfaction compared to CEI and PCEA
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None