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

NCT06889285 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 76

Last updated 2025-03-21

No results posted yet for this study

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.

Conditions

  • Analgesia, Epidural

Interventions

PROCEDURE

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

PROCEDURE

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

Sponsors & Collaborators

  • Hospital Universiti Sains Malaysia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2025-08-30
Completion
2025-12-30

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06889285 on ClinicalTrials.gov