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

NCT07592364 | Not Yet Recruiting

• 1 other identifier: JKEUPM-2026-161
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pregnant Women; Labour Analgesia

Keywords

Parturient; Pregnant; PIEB; PCEA; CEI; Labour Analgesia

Outcome Measures

Primary Outcomes (3)

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

  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

  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

  maternal satisfaction is via likert scale with 1 is very dissatisfied and 5 is very satisfied

  From enrollment to the removal of epidural catheter

Secondary Outcomes (2)

• compare the incidence of breakthrough pain requiring clinician bolus in PIEB plus PCEA versus CEI plus PCEA

  From epidural catheter insertion until removal of epidural catheter

• compare the incidence of motor blocked in PIEB plus PCEA versus CEI plus PCEA

  after epidural catheter insertion until the removal of epidural catheter

Study Arms (2)

PIEB plus PCEA

ACTIVE COMPARATOR

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

CEI plus PCEA

ACTIVE COMPARATOR

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

Interventions

Programmed intermittent epidural bolus 10 ml PROCEDURE

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

Also known as: patient controlled epidural analgesia

PIEB plus PCEA

continuous epidural infusion PROCEDURE

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

Also known as: patient controlled epidural analgesia

CEI plus PCEA

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Aiman Bin Ab Adzim: lead

Study Sites (1)

Hospital Sultan Abdul Aziz Shah UPM

Serdang, Selangor, 43400, Malaysia

Location

Related Publications (20)

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• Yadav M, et al. Randomized comparison of CEI + PCEA versus PIEB + PCEA for labour analgesia. *Indian J Anaesth.* 2021;65(12):959-965.

  BACKGROUND

• Zhang T, et al. Comparative review of PIEB and CEI methods for labour analgesia. *Front Med.* 2023;10:1054523.

  BACKGROUND

• Fong J, et al. Network meta-analysis of PIEB and CEI techniques for epidural labour analgesia. *Anesth Pain Med.* 2022;12(3):e12145.

  BACKGROUND

• National Institute for Health and Care Excellence (NICE). Continuous versus intermittent epidural regimens for labour analgesia: evidence summary. 2021.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• Carvalho B, et al. Mechanistic evaluation of programmed intermittent bolus delivery for labour analgesia. *Anesthesiology.* 2017;127(2):198-205.

  BACKGROUND

• Fettes PD, et al. Programmed intermittent epidural bolus in labour analgesia: current evidence and practice recommendations. *Eur J Anaesthesiol.* 2021;38(8):757-765.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 32812652 BACKGROUND

• 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.

  PMID: 31200641 BACKGROUND

• 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.

  PMID: 3289769 BACKGROUND

• 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.

  PMID: 16492849 BACKGROUND

• 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.

  BACKGROUND

• 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.

  PMID: 35119026 BACKGROUND

• 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.

  BACKGROUND

• 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

  BACKGROUND

Central Study Contacts

Aiman Ab Adzim

CONTACT

+60132750766; aimanadzim1224@gmail.com

Nik Rowina Nik Mohammed

CONTACT

+60199415676; nikrowina@upm.edu.my

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Medical officer

Study Record Dates

• First Submitted: May 1, 2026
• First Posted: May 18, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 18, 2026

Record last verified: 2026-05

Locations

MY (1)