Programmed Intermittent Epidural Bolus Compared With Continuous Infusion in Multiparous Women

NARecruitingINTERVENTIONAL
Enrollment

186

Participants

Timeline

Start Date

September 25, 2024

Primary Completion Date

December 31, 2025

Study Completion Date

March 31, 2026

Conditions
Breakthrough Pain
Interventions
DRUG

programmed intermittent Bolus epidural analgesia

"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."

DRUG

continuous epidural infusion

"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."

Trial Locations (1)

1641100

RECRUITING

Holy Family Hospital, Nazareth

All Listed Sponsors
lead

Holy Family Hospital, Nazareth, Israel

OTHER