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

NCT06889285 | Not Yet Recruiting Phase 4 DMC

• 1 other identifier: USM/JEPeM/KK/23110826
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• To compare the incidence of motor block during labour between parturient with PIEB + PCEA and those with CEI.

  Bromage score is measured hourly after epidural insertion. If there is any time when Bromage is greater than 0, then will be considered presence of motor block.

  1 year

Secondary Outcomes (3)

• To compare the duration of second stage labour between parturient with PIEB+CEA and those with CEI.

  1 year

• To compare the local anaesthetic consumption (in mg/hr) during labour between parturient with PIEB + PCEA and those with CEI

  1 year

• To compare the satisfaction score during labour between parturient with PIEB+PCEA and those with CEI

  1 year

Study Arms (2)

Continuous Epidural Analgesia

EXPERIMENTAL

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: Continuos epidural infusion

Programmed Intermittent Epidural Bolus

EXPERIMENTAL

Patient in this group receive programmed intermittent epidural bolus (PIEB) using cocktail of Ropivacaine 0.05% + fentanyl 2mcg/ml, with 10ml cocktail loading when started, then 10ml hourly bolus, with patient controlled epidural analgesia (PCEA) - 10ml per patient request, lockout interval 10minutes.

Procedure: Programmed intermittent epidural bolus

Interventions

Continuos epidural infusion PROCEDURE

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

Continuous Epidural Analgesia

Programmed intermittent epidural bolus PROCEDURE

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

Programmed Intermittent Epidural Bolus

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: only pregnant women is eligible for this study
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age \> 18 years old
• ASA 2 \& 3w

You may not qualify if:

• patient refusal
• significant comorbiddities, eg patient with heart disease, kidney diseae, neurological disoder
• contraindicated to neuraxial blockade
• allergic to local anesthetic agent or opioid
• obstetric complications, eg pre-eclampsia, leaking liqour, suspicious CTG
• morbid obesity, BMI \> 40
• grandmultiparous ( \> 5biths at \> 20 weeks gestation)
• combined spinal epidural technique for labour epidural analgesia
• height \< 145cm

Sponsors & Collaborators

• Hospital Universiti Sains Malaysia: lead

Study Sites (1)

Hospital Pakar Universiti Sains Malaysia

Kubang Kerian, Kelantan, 16150, Malaysia

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Dr Koeh Shao Keong, Doctor of Medicine

CONTACT

+60169686388; keong705@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participant and clinician cant be blinded in this study in view that CADD-Solis pump used in programmed intermittent epidural bolus (PIEB) group is different from conventional infusion pump with distinct patient bolus button. Although participant can be blinded by introducing placebo bolus in continuous epidural infusion (CEI) group, it is unethical to do so, especially when involves obstetric patient that encounter labour pain during active phase of labor. Only assessor can be blinded by masking the labor epidural analgesia delivery pump (be it CADD-Solis pump or conventional infusion pump), thus to reduce bias in the observed outcome
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: March 15, 2025
• First Posted: March 21, 2025
• Study Start: April 1, 2025
• Primary Completion: August 30, 2025
• Study Completion: December 30, 2025
• Last Updated: March 21, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)