Clinical Trial

Comparison of Safety and Efficacy Between PIEB and CEI for Labour Epidural Analgesia

Not Yet Recruiting Phase 4
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Record status
This record was last updated March 21, 2025 (before its estimated August 30, 2025 completion). Its status may not reflect the trial's current state.
Summary
The goal of this clinical trial is to compare safety and efficacy of programmed intermittent epidural bolus (PEIB) and continuous epidural infusion (CEI) in parturients during active phase of labour. The main questions aimed to answer are: * Will parturient using PIEB+PCEA has lower incidence of motor block as compared to CEI during labour? * Will parturient using PIEB + PCEA has lower local anaesthetic consumption (in mg/hr) as compared to CEI during labour? * Will parturient using PIEB + PCEA has shorter duration of second stage labour as compared to CEI? * Will parturient using PIEB + PCEA has better satisfaction score when compared to CEI during labour? Participants will be randomised into PIEB group and CEI group after informed consent taken * All participants will be taken baseline demographic data, vital signs, Bromage score, cardiotocograph prior intervention * Labour epidural will be inserted and started on PIEB protocol or CEI protocol based on randomisation * Participants vital signs and Bromage score will be recorded hourly till baby delivery * In the end of delivery, total LA consumption and duration of second stage will be recorded * Within 24 hours, participants will be interviewed on their satisfaction score on labour epidural analgesia. Researchers will compare PIEB and CEI to see if PIEB has better safety and efficacy as compared to CEI in labour epidural analgesia.
Trial Details
NCT Number NCT06889285
Lead Sponsor Hospital Universiti Sains Malaysia
Conditions Analgesia, Epidural
Enrollment 76 participants
Start Date 2025-04-01
Primary Completion 2025-08-30 (estimated)
Study Completion 2025-12-30 (estimated)
Updated on ClinicalTrials.gov 2025-03-21