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

13. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

88

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Malaysia
    • Selangor
      • Serdang, Selangor, Malaysia, 43400
        • Hospital Sultan Abdul Aziz Shah UPM
        • Kontakt:
        • Kontakt:
          • Nik Rowina Nik Mohammed, MD, MMed Anaesthesiology
          • Telefonnummer: +60199415676
          • E-mail: nikrowina@upm.edu.my
        • Ledende efterforsker:
          • Aiman Ab Adzim, MBBS
        • Underforsker:
          • Nik Rowina Nik Mohammed, MD, MMED Anaesthesiology
        • Underforsker:
          • Previna a/p Anatory, MD, MMED Anaesthesiology
        • Underforsker:
          • Nurul Najwa Mohd Noor, MD, MMED Anaesthesiology

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Tredobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: 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
Andre navne:
  • patient controlled epidural analgesia
Aktiv komparator: 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
Andre navne:
  • patient controlled epidural analgesia

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
compare the effectiveness of PIEB plus PCEA versus CEI plus PCEA in labour analgesia via VAS score, total LA consumption and maternal satisfaction
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
compare the incidence of breakthrough pain requiring clinician bolus in PIEB plus PCEA versus CEI plus PCEA
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Aiman Bin Ab Adzim

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

31. maj 2027

Studieafslutning (Anslået)

31. december 2027

Datoer for studieregistrering

Først indsendt

1. maj 2026

Først indsendt, der opfyldte QC-kriterier

13. maj 2026

Først opslået (Faktiske)

18. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

18. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • JKEUPM-2026-161

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

UBESLUTET

IPD-planbeskrivelse

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

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Programmed intermittent epidural bolus 10 ml

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Betingelser

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