A Research Comparing Efficacy of PIEB Plus PCEA vs CEI Plus PCEA for Labour Analgesia
13 maggio 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Tipo di studio
Interventistico
Iscrizione (Stimato)
88
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Aiman Ab Adzim
- Numero di telefono: +60132750766
- Email: aimanadzim1224@gmail.com
Backup dei contatti dello studio
- Nome: Nik Rowina Nik Mohammed
- Numero di telefono: +60199415676
- Email: nikrowina@upm.edu.my
Luoghi di studio
-
-
Selangor
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Serdang, Selangor, Malaysia, 43400
- Hospital Sultan Abdul Aziz Shah UPM
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Contatto:
- Aiman Ab Adzim, MBBS
- Numero di telefono: +60132750766
- Email: aimanadzim1224@gmail.com
-
Contatto:
- Nik Rowina Nik Mohammed, MD, MMed Anaesthesiology
- Numero di telefono: +60199415676
- Email: nikrowina@upm.edu.my
-
Investigatore principale:
- Aiman Ab Adzim, MBBS
-
Sub-investigatore:
- Nik Rowina Nik Mohammed, MD, MMED Anaesthesiology
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Sub-investigatore:
- Previna a/p Anatory, MD, MMED Anaesthesiology
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Sub-investigatore:
- Nurul Najwa Mohd Noor, MD, MMED Anaesthesiology
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-
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Triplicare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Comparatore attivo: 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
|
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
Altri nomi:
|
|
Comparatore attivo: 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
|
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
Altri nomi:
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
compare the effectiveness of PIEB plus PCEA versus CEI plus PCEA in labour analgesia via VAS score, total LA consumption and maternal satisfaction
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
compare the incidence of breakthrough pain requiring clinician bolus in PIEB plus PCEA versus CEI plus PCEA
Lasso di tempo: From epidural catheter insertion until removal of epidural catheter
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comparing number of breakthrough pain which requires intervention by the clinician to give rescue bolus in between each group
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From epidural catheter insertion until removal of epidural catheter
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compare the incidence of motor blocked in PIEB plus PCEA versus CEI plus PCEA
Lasso di tempo: after epidural catheter insertion until the removal of epidural catheter
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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
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
- Wong CA, Ratliff JT, Sullivan JT, Scavone BM, Toledo P, McCarthy RJ. A randomized comparison of programmed intermittent epidural bolus with continuous epidural infusion for labor analgesia. Anesth Analg. 2006 Mar;102(3):904-9. doi: 10.1213/01.ane.0000197778.57615.1a.
- 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.
- 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.
- 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.
- Liu Q, et al. Comparison of different delivery modalities of epidural analgesia: a systematic review and network meta-analysis. *Can J Anaesth.* 2022;69(8):871-885.
- Wang XX, Zhang XL, Zhang ZX, Xin ZQ, Guo HJ, Liu HY, Xiao J, Zhang YL, Yuan SZ. Programmed intermittent epidural bolus in parturients: A meta-analysis of randomized controlled trials. Medicine (Baltimore). 2022 Feb 4;101(5):e28742. doi: 10.1097/MD.0000000000028742.
- Kim Y, Lee D, Kwon H, et al. Analgesic efficacy of programmed intermittent epidural bolus versus continuous epidural infusion for labour analgesia. *J Anaesth Clin Pharmacol.* 2022;38(2):160-166.
- Aleksandrovich YS, Murieva EA, Pshenisnov KV, Riazanova OV. Hormonal status of the mother and her newborn child after using long-term epidural analgesia in childbirth. Pediatrician 2011; 2: 51-55
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
1 luglio 2026
Completamento primario (Stimato)
31 maggio 2027
Completamento dello studio (Stimato)
31 dicembre 2027
Date di iscrizione allo studio
Primo inviato
1 maggio 2026
Primo inviato che soddisfa i criteri di controllo qualità
13 maggio 2026
Primo Inserito (Effettivo)
18 maggio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
18 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
13 maggio 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Altri numeri di identificazione dello studio
- JKEUPM-2026-161
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
INDECISO
Descrizione del piano IPD
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
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
prodotto fabbricato ed esportato dagli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .