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Pregnant WomenNCT07592364

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

A study testing Programmed intermittent epidural bolus 10 ml and continuous epidural infusion in people with Pregnant Women and Labour Analgesia, run by Aiman Bin Ab Adzim at 1 site in Malaysia.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Pregnant Women, Labour Analgesia
What is being tested?
Programmed intermittent epidural bolus 10 ml and continuous epidural infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
1 siteMalaysia
Study dates
1 Jul 2026to 31 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • Allergies to LA and opioids
  • Severe systemic and mental disease
  • Contraindication to regional analgesia
  • Hemodynamic instabilities
  • Systemic coagulopathies
  • Treatment with anticoagulants
Show all 9Show fewer
  • Severe obstetric complications - eg. eclampsia, placenta previae
  • Patient refusal
  • Failed epidural insertion

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Aiman Ab Adzim contact

+60132750766

aimanadzim1224@gmail.com

Nik Rowina Nik Mohammed contact

+60199415676

nikrowina@upm.edu.my

Malaysia1 site

  • Hospital Sultan Abdul Aziz Shah UPM

    Serdang, Selangor, 43400

    Aiman Ab Adzim, MBBS, +60132750766, aimanadzim1224@gmail.com

    Nik Rowina Nik Mohammed, MD, MMed Anaesthesiology, +60199415676, nikrowina@upm.edu.my

Other trials in Malaysia

About this study

Official 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

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.

Read more

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.

Being tested
Programmed intermittent epidural bolus 10 ml, continuous epidural infusion
Keywords
Parturient, Pregnant, PIEB, PCEA, CEI, Labour Analgesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Programmed intermittent epidural bolus 10 mlProcedure or surgery

    Also called patient controlled epidural analgesia

    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

  • continuous epidural infusionProcedure or surgery

    Also called patient controlled epidural analgesia

    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

Study groups in NCT07592364
Study groupRoleWhat they receive
PIEB plus PCEAActive comparatorPatient 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
Receives: Procedure: Programmed intermittent epidural bolus 10 ml
CEI plus PCEAActive comparatorPatient 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
Receives: Procedure: continuous epidural infusion

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

    Measured: From enrollment to the removal of epidural catheter

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

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

    Measured: From enrollment to the removal of epidural catheter

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

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

    Measured: From enrollment to the removal of epidural catheter

Secondary outcomes (2)

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

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

    Measured: From epidural catheter insertion until removal of epidural catheter

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

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

    Measured: after epidural catheter insertion until the removal of epidural catheter

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2026
  2. Study start1 Jul 2026 (estimated)
  3. Primary completion31 May 2027 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07592364
Sponsor's protocol ID
JKEUPM-2026-161
Status last verified
May 2026
First submitted
1 May 2026
Last updated
18 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided: 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

Publications

  • Ryu JH, et al. Hemodynamic and motor block characteristics of intermittent bolus epidural regimens in parturients. *Reg Anesth Pain Med.* 2018;43(5):497-503.

  • Zhang N, et al. Effect of adrenaline-supplemented PIEB vs CEI on analgesia and satisfaction in labouring women. *Anaesth Intensive Care.* 2020;48(6):423-430.

  • Lee JS, et al. Network meta-analysis of epidural infusion techniques for labour pain: PIEB versus CEI regimens. *Pain Pract.* 2023;23(4):412-420.

  • Yadav M, et al. Randomized comparison of CEI + PCEA versus PIEB + PCEA for labour analgesia. *Indian J Anaesth.* 2021;65(12):959-965.

  • Zhang T, et al. Comparative review of PIEB and CEI methods for labour analgesia. *Front Med.* 2023;10:1054523.

  • Fong J, et al. Network meta-analysis of PIEB and CEI techniques for epidural labour analgesia. *Anesth Pain Med.* 2022;12(3):e12145.

  • National Institute for Health and Care Excellence (NICE). Continuous versus intermittent epidural regimens for labour analgesia: evidence summary. 2021.

  • McKenzie CP, et al. Comparative efficacy of PIEB + PCEA versus CEI + PCEA on pain scores and local anaesthetic use. *Int J Obstet Anesth.* 2019;37:1-8.

  • George RB, et al. Impact of PIEB on maternal satisfaction and motor block during labour: a randomised controlled trial. *Br J Anaesth.* 2020;125(4):e345-e352.

  • Carvalho B, et al. Mechanistic evaluation of programmed intermittent bolus delivery for labour analgesia. *Anesthesiology.* 2017;127(2):198-205.

  • Fettes PD, et al. Programmed intermittent epidural bolus in labour analgesia: current evidence and practice recommendations. *Eur J Anaesthesiol.* 2021;38(8):757-765.

  • Zhang S, et al. Programmed intermittent epidural bolus for labour analgesia: a systematic review and meta-analysis. *Int J Environ Res Public Health.* 2020;17(19):7082.

  • Haidl F, Arne Rosseland L, Rorvik AM, Dahl V. Programmed intermittent boluses vs continuous epidural infusion in labor using an adrenaline containing solution: A randomized trial. Acta Anaesthesiol Scand. 2020 Nov;64(10):1505-1512. doi: 10.1111/aas.13689. Epub 2020 Sep 7.

    PubMed 32812652

  • Higashi M, Shigematsu K, Nakamori E, Sakurai S, Yamaura K. Efficacy of programmed intermittent bolus epidural analgesia in thoracic surgery: a randomized controlled trial. BMC Anesthesiol. 2019 Jun 15;19(1):107. doi: 10.1186/s12871-019-0780-0.

    PubMed 31200641

  • Gambling DR, Yu P, Cole C, McMorland GH, Palmer L. A comparative study of patient controlled epidural analgesia (PCEA) and continuous infusion epidural analgesia (CIEA) during labour. Can J Anaesth. 1988 May;35(3 ( Pt 1)):249-54. doi: 10.1007/BF03010618.

    PubMed 3289769

Questions about this trial

What is this clinical trial studying?

A study testing Programmed intermittent epidural bolus 10 ml and continuous epidural infusion in people with Pregnant Women and Labour Analgesia, run by Aiman Bin Ab Adzim at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Aiman Ab Adzim (+60132750766, aimanadzim1224@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07592364, which also lists 20 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.

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