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

Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorHospital Universiti Sains Malaysia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

age > 18 years old

ASA 2 & 3w

Disqualifiers

patient refusal

significant comorbiddities, eg patient with heart disease, kidney diseae, neurological disoder

contraindicated to neuraxial blockade

allergic to local anesthetic agent or opioid

Trial design

Design model

Parallel

Treatments tested in this trial

  • Continuos epidural infusion

    Procedure/Surgery

    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

    Procedure/Surgery

    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

Treatment groups

76 Participants
are divided into 2 treatment groups
Group A: Continuous Epidural AnalgesiaExperimental treatment 1 intervention
Group B: Programmed Intermittent Epidural BolusExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
1 year

Secondary outcomes

1

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

\- From patient partogram, we will calculate duration of second stage labour for each patient (from cervical os 10cm till delivery of baby)

Time frame
1 year
2

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

For PIEB+ PCEA group, the LA consumption will be retrieved from CADD-Solis pump which record total of LA use and number of patient's requested bolus. As for CEI group, its consumption can be derived from amount of LA given in the syringe and manual record where amount of physician bolus given.

Time frame
1 year
3

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

Within 24 hours after delivery, parturient will be interviewed on the satisfaction score on the epidural regimen given with numerical rating scale from 0 to 100, where 0 is most unsatisfied and 100 is most satisfied.

Time frame
1 year

Other outcomes

Sponsors and contacts

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