Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-30 @ 2:21 AM
Study NCT ID:
NCT07395934
Status:
RECRUITING
Last Update Posted:
2026-02-09
First Post:
2026-01-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing PIEB and CEI for Labor Pain Relief
Sponsor:
Da Nang Family General Hospital
Organization:
Study Overview
Official Title:
Comparison of Continuous Epidural Infusion vs. Programmed Intermittent Epidural Bolus Combined With Patient-Controlled Epidural Analgesia for Labor Pain Relief: A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2026-01
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:
COPILOT
Brief Summary:
The purpose of this randomized controlled trial is to compare the efficacy and safety of two epidural analgesia maintenance methods for labor pain relief: Programmed Intermittent Epidural Bolus (PIEB) and Continuous Epidural Infusion (CEI), both combined with Patient-Controlled Epidural Analgesia (PCEA). The study aims to evaluate which technique provides superior analgesia while minimizing anesthetic consumption and preserving maternal motor function. A total of 60 parturients at Family Hospital, Da Nang, will be randomly assigned to either the PIEB or CEI group. Outcomes including pain intensity (VAS scores), total drug consumption, maternal satisfaction, and neonatal Apgar scores will be assessed.
Detailed Description:
This study is a prospective, randomized controlled trial conducted at the Labor and Delivery Unit of Family Hospital, Da Nang. The investigation focuses on the clinical advantages of automated high-pressure bolus delivery (PIEB) compared to constant low-pressure flow (CEI) in optimizing the spread of local anesthetics within the epidural space.
Clinical Procedures: All participants receive a standardized initial manual bolus of 10 mL (0.1% Ropivacaine and 2 mcg/mL Fentanyl) to establish a baseline sensory block. Following this induction, patients are managed according to their assigned study arm:
PIEB Group: Analgesia is maintained using a programmed pump set to deliver an automated bolus of 8 mL every 60 minutes, starting one hour after the initial dose.
CEI Group: Analgesia is maintained via a continuous infusion of the same anesthetic solution at a constant rate of 8 mL/hour.
Analgesia Management and Rescue Protocol: Both groups have access to PCEA, allowing for self-administered 5 mL boluses with a 10-minute lockout period, capped at a maximum of 20 mL per hour.
To ensure maternal comfort, a standardized rescue protocol is strictly followed: if the Visual Analog Scale (VAS) score remains \> 4 after two consecutive PCEA demands, a manual rescue bolus of 5 mL is administered by the anesthesia team.
Clinical Procedures: All participants receive a standardized initial manual bolus of 10 mL (0.1% Ropivacaine and 2 mcg/mL Fentanyl) to establish a baseline sensory block. Following this induction, patients are managed according to their assigned study arm:
PIEB Group: Analgesia is maintained using a programmed pump set to deliver an automated bolus of 8 mL every 60 minutes, starting one hour after the initial dose.
CEI Group: Analgesia is maintained via a continuous infusion of the same anesthetic solution at a constant rate of 8 mL/hour.
Analgesia Management and Rescue Protocol: Both groups have access to PCEA, allowing for self-administered 5 mL boluses with a 10-minute lockout period, capped at a maximum of 20 mL per hour.
To ensure maternal comfort, a standardized rescue protocol is strictly followed: if the Visual Analog Scale (VAS) score remains \> 4 after two consecutive PCEA demands, a manual rescue bolus of 5 mL is administered by the anesthesia team.
Study Oversight
Has Oversight DMC:
False
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?:
None
Is an FDA AA801 Violation?: