A Research Comparing Efficacy of PIEB Plus PCEA vs CEI Plus PCEA for Labour Analgesia
13 de mayo de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
88
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Aiman Ab Adzim
- Número de teléfono: +60132750766
- Correo electrónico: aimanadzim1224@gmail.com
Copia de seguridad de contactos de estudio
- Nombre: Nik Rowina Nik Mohammed
- Número de teléfono: +60199415676
- Correo electrónico: nikrowina@upm.edu.my
Ubicaciones de estudio
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Selangor
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Serdang, Selangor, Malasia, 43400
- Hospital Sultan Abdul Aziz Shah UPM
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Contacto:
- Aiman Ab Adzim, MBBS
- Número de teléfono: +60132750766
- Correo electrónico: aimanadzim1224@gmail.com
-
Contacto:
- Nik Rowina Nik Mohammed, MD, MMed Anaesthesiology
- Número de teléfono: +60199415676
- Correo electrónico: nikrowina@upm.edu.my
-
Investigador principal:
- Aiman Ab Adzim, MBBS
-
Sub-Investigador:
- Nik Rowina Nik Mohammed, MD, MMED Anaesthesiology
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Sub-Investigador:
- Previna a/p Anatory, MD, MMED Anaesthesiology
-
Sub-Investigador:
- Nurul Najwa Mohd Noor, MD, MMED Anaesthesiology
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-
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Comparador activo: 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
Otros nombres:
|
|
Comparador activo: 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
Otros nombres:
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
compare the effectiveness of PIEB plus PCEA versus CEI plus PCEA in labour analgesia via VAS score, total LA consumption and maternal satisfaction
Periodo de tiempo: 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
|
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compare the effectiveness of PIEB plus PCEA versus CEI plus PCEA in labour analgesia via total LA consumption
Periodo de tiempo: From enrollment to the removal of epidural catheter
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total Local Anaesthesia (LA) consumption related to the total amount which is used throughout the procedure
|
From enrollment to the removal of epidural catheter
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compare the effectiveness of PIEB plus PCEA versus CEI plus PCEA in labour analgesia via VAS score, total LA consumption and maternal satisfaction
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
compare the incidence of breakthrough pain requiring clinician bolus in PIEB plus PCEA versus CEI plus PCEA
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- 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
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
1 de julio de 2026
Finalización primaria (Estimado)
31 de mayo de 2027
Finalización del estudio (Estimado)
31 de diciembre de 2027
Fechas de registro del estudio
Enviado por primera vez
1 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
13 de mayo de 2026
Publicado por primera vez (Actual)
18 de mayo de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
13 de mayo de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- JKEUPM-2026-161
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
INDECISO
Descripción del plan 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
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
producto fabricado y exportado desde los EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .