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

May 13, 2026 updated by: Aiman Bin Ab Adzim

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Malaysia
    • Selangor
      • Serdang, Selangor, Malaysia, 43400
        • Hospital Sultan Abdul Aziz Shah UPM
        • Contact:
        • Contact:
          • Nik Rowina Nik Mohammed, MD, MMed Anaesthesiology
          • Phone Number: +60199415676
          • Email: nikrowina@upm.edu.my
        • Principal Investigator:
          • Aiman Ab Adzim, MBBS
        • Sub-Investigator:
          • Nik Rowina Nik Mohammed, MD, MMED Anaesthesiology
        • Sub-Investigator:
          • Previna a/p Anatory, MD, MMED Anaesthesiology
        • Sub-Investigator:
          • Nurul Najwa Mohd Noor, MD, MMED Anaesthesiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PIEB plus PCEA
Patient will received programmed intermitted epidural bolus plus patient controlled epidural analgesia with a drug concentration of 0.05% ropivacaine plus fentanyl 2mcg/ml. The bolus and patient controlled will be 10mls of the drug concentration
Procedure: Programmed intermittent epidural bolus 10 ml
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
Active Comparator: CEI plus PCEA
Patient will received continuous epidural infusion plus patient controlled epidural analgesia with a drug concentration of 0.05% ropivacaine plus fentanyl 2mcg/ml. The infusion will run at 10ml/hour and patient controlled will be 10mls of the drug concentration
Procedure: continuous epidural infusion
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From enrollment to the removal of epidural catheter
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
From enrollment to the removal of epidural catheter
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
From enrollment to the removal of epidural catheter

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
From epidural catheter insertion until removal of epidural catheter
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
after epidural catheter insertion until the removal of epidural catheter

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aiman Bin Ab Adzim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 2026

Primary Completion (Estimated)

May 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

May 1, 2026

First Submitted That Met QC Criteria

May 13, 2026

First Posted (Actual)

May 18, 2026

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • JKEUPM-2026-161

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

This is a study for postgraduate studies and investigator might not be involved in the specific related field anymore (subspecialty of obstetric anaesthesia) after the study completed

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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