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

NCT07592364 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2026-05-18

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Aiman Bin Ab Adzim

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-05-31
Completion
2027-12-31

Countries

  • Malaysia

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07592364 on ClinicalTrials.gov