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NCT Number: NCT07592364

A Research Comparing Efficacy of PIEB Plus PCEA vs CEI Plus PCEA for Labour Analgesia

During labour process, one of the most effective ways to manage pain is via epidural analgesia. It is commonly and widely use for all pregnant women underwent labour process. It provides good pain relief during labour process especially for contraction pain and pain during descending of baby during delivery.

During epidural insertion, a small catheter (which is flexible and thin) will be inserted via epidural needle at the back. Using this epidural catheter, pain medication will be given to ease and help controlling the pain. This procedure is usually done after you have been admitted to labour room.

In this research, investigator will compare among two different method of epidural administration which are:

- Programmed Intermittent Epidural Bolus with Patient-Controlled Epidural Analgesia (PIEB +

PCEA):

* This method will enable the medication to be served automatically within the set time through the epidural catheter and allows for participants to manage additional boluses of medication according to the participants pain level.

- Continuous Epidural Infusion with Patient-Controlled Epidural Analgesia (CEI + PCEA): * This method will deliver continuous infusion of medication and allows for participants to manage additional boluses of medication according to the participants pain level.

Investigator want to determine the best method between this two in order to have better pain control, less usage of medication and improving the satisfaction of patient. In participating this research, the participants will help us in understanding the best method to be use for the labour process in which eventually help other future patient who is in need.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Sultan Abdul Aziz Shah UPM

Serdang, Selangor, 43400, Malaysia

Location contact

Aiman Ab Adzim, MBBS

CONTACT

[email protected]

+60132750766

Aiman Ab Adzim, MBBS

PRINCIPAL_INVESTIGATOR

Nik Rowina Nik Mohammed, MD, MMED Anaesthesiology

SUB_INVESTIGATOR

Nik Rowina Nik Mohammed, MD, MMed Anaesthesiology

CONTACT

[email protected]

+60199415676

Nurul Najwa Mohd Noor, MD, MMED Anaesthesiology

SUB_INVESTIGATOR

Previna a/p Anatory, MD, MMED Anaesthesiology

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All pregnant female > 36 weeks of gestation
  • Age 18 years old and above
  • ASA I and II
  • Consented for study

Exclusion criteria

  • Allergies to LA and opioids
  • Severe systemic and mental disease
  • Contraindication to regional analgesia
  • Hemodynamic instabilities
  • Systemic coagulopathies
  • Treatment with anticoagulants
  • Severe obstetric complications - eg. eclampsia, placenta previae
  • Patient refusal
  • Failed epidural insertion

Treatment and study plan

Programmed intermittent epidural bolus 10 ml

Procedure

Programmed intermitted epidural bolus plus patient controlled epidural analgesia with drug and concentration of ropivacaine 0.05% plus fentanyl 2mcg/ml. Patient will received hourly bolus of 10mls and patient controlled 10mls of bolus

Other names: patient controlled epidural analgesia

Continuous Epidural Infusion

Procedure

Continuous epidural infusion plus patient controlled epidural analgesia with drug and concentration of ropivacaine 0.05% plus fentanyl 2mcg/ml. Patient will received 10mls/hr infusion plus patient controlled of 10mls per bolus

Other names: patient controlled epidural analgesia

Primary outcomes

  1. compare the effectiveness of PIEB plus PCEA versus CEI plus PCEA in labour analgesia via VAS score, total LA consumption and maternal satisfaction

    Time frame: From enrollment to the removal of epidural catheter

    Visual Analogue Scale (VAS) score with 0 for no pain and 10 for worst possible pain

  2. compare the effectiveness of PIEB plus PCEA versus CEI plus PCEA in labour analgesia via total LA consumption

    Time frame: From enrollment to the removal of epidural catheter

    total Local Anaesthesia (LA) consumption related to the total amount which is used throughout the procedure

  3. compare the effectiveness of PIEB plus PCEA versus CEI plus PCEA in labour analgesia via VAS score, total LA consumption and maternal satisfaction

    Time frame: From enrollment to the removal of epidural catheter

    maternal satisfaction is via likert scale with 1 is very dissatisfied and 5 is very satisfied

Secondary outcomes

  1. compare the incidence of breakthrough pain requiring clinician bolus in PIEB plus PCEA versus CEI plus PCEA

    Time frame: From epidural catheter insertion until removal of epidural catheter

    comparing number of breakthrough pain which requires intervention by the clinician to give rescue bolus in between each group

  2. compare the incidence of motor blocked in PIEB plus PCEA versus CEI plus PCEA

    Time frame: after epidural catheter insertion until the removal of epidural catheter

    comparing if there is any occurence of motor blockade in anytime during the study period by modified bromage scale

Study contacts

Contact information is provided by the study sponsor or research team.

Aiman Ab Adzim

CONTACT

[email protected]

+60132750766

Nik Rowina Nik Mohammed

CONTACT

[email protected]

+60199415676

Sponsors and collaborators

Lead sponsor

Aiman Bin Ab Adzim

Other

Registry information

Official study title

A Randomized Controlled Trial Comparing Efficacy of Programmed Intermittent Epidural Bolus (PIEB) Plus Patient-Controlled Epidural Analgesia (PCEA) Versus Continuous Epidural Infusion (CEI) Plus Patient-Controlled Epidural Analgesia (PCEA) for Labour Analgesia

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 18, 2026
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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