A Research Comparing Efficacy of PIEB Plus PCEA vs CEI Plus PCEA for Labour Analgesia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Programmed intermittent epidural bolus 10 ml, continuous epidural infusion.
- Who it may be relevant to
- Registry conditions: Pregnant Women, Labour Analgesia. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Malaysia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- 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 - 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
Primary outcome measures
- 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]
- compare the effectiveness of PIEB plus PCEA versus CEI plus PCEA in labour analgesia via total LA consumption [Time frame: 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 [Time frame: From enrollment to the removal of epidural catheter]
Secondary outcome measures (2)
- compare the incidence of breakthrough pain requiring clinician bolus in PIEB plus PCEA versus CEI plus PCEA [Time frame: From epidural catheter insertion until removal of epidural catheter]
- compare the incidence of motor blocked in PIEB plus PCEA versus CEI plus PCEA [Time frame: after epidural catheter insertion until the removal of epidural catheter]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Malaysia · 1 center
- Hospital Sultan Abdul Aziz Shah UPM — Serdang
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.
Identifiers
NCT: NCT07592364 · JKEUPM-2026-161