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

Официальное название

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

Обзор

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.

Вмешательства

• Процедура 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
• Процедура 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

Первичные конечные точки

• compare the effectiveness of PIEB plus PCEA versus CEI plus PCEA in labour analgesia via VAS score, total LA consumption and maternal satisfaction [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: From enrollment to the removal of epidural catheter]

Вторичные конечные точки (2)

• compare the incidence of breakthrough pain requiring clinician bolus in PIEB plus PCEA versus CEI plus PCEA [Срок оценки: From epidural catheter insertion until removal of epidural catheter]
• compare the incidence of motor blocked in PIEB plus PCEA versus CEI plus PCEA [Срок оценки: after epidural catheter insertion until the removal of epidural catheter]

Критерии участия

Критерии включения

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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Малайзия · 1 центр

• Hospital Sultan Abdul Aziz Shah UPM — Serdang

Публикации

• 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.

Идентификаторы

NCT: NCT07592364 · JKEUPM-2026-161

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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