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Comparison of Safety and Efficacy Between PIEB and CEI for Labour Epidural Analgesia
Sponsor: Hospital Universiti Sains Malaysia
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.
Official title: Comparison of Safety and Efficacy Between Programmed Intermittent Epidural Bolus (PIEB) and Continuous Epidural Infusion (CEI) for Labour Epidural Analgesia: a Randomized Controlled Trial
Key Details
Gender
FEMALE
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
76
Start Date
2025-04-01
Completion Date
2025-12-30
Last Updated
2025-03-21
Healthy Volunteers
No
Conditions
Interventions
Continuos epidural infusion
This group of parturient will be inserted epidural catheter at L3/L4 or L4/L5 depending on anaesthetist-in-charge justification, epidural catheter will be kept 4-5 cm in epidural space and anchored with adhesive tape. Similarly, a test dose of LA Lignocaine 2% 2ml will be given after epidural insertion. Infusion tubing will be primed in advance. Epidural catheter will be connected to epidural cocktail (Bupivacaine 0.1% + Fentanyl 2mcg/ml in 50ml mixture) with the protocol as below: (directly extracted from Malaysia Pain management in Obstetrics and Gynaecology Procedure Guideline 2023) * Loading dose 10 ml * Continuous infusion: 10ml/hour
Programmed intermittent epidural bolus
This group patient will be inserted epidural catheter at L3/L4 or L4/L5 depending on anaesthetist-in-charge justification, epidural catheter will be kept 4-5 cm in epidural space and anchored with adhesive tape. A test dose of LA Lignocaine 2% 2ml will be given after epidural insertion. CADD-Solis infusion tubing will be primed in advance. Epidural catheter will be connected to epidural cocktail (Ropivacaine 0.05% + Fentanyl 2mcg/ml in 100ml mixture) with the protocol as below: * Loading dose: 10ml * Intermittent bolus: 10ml, bolus interval 1 hour, next bolus 1 hour * PCEA dose: 10ml, lockout interval 10 minutes
Locations (1)
Hospital Pakar Universiti Sains Malaysia
Kubang Kerian, Kelantan, Malaysia