An interventional study of Programmed intermittent epidural bolus 10 ml and continuous epidural infusion in Pregnant Women and Labour Analgesia, sponsored by Aiman Bin Ab Adzim. Not yet recruiting at 1 site in Malaysia. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-18.
Sponsored by Aiman Bin Ab Adzim · Not applicable, Interventional, and Treatment
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):
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.
This is the only study on the registry with Aiman Bin Ab Adzim as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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
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
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
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
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
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
total Local Anaesthesia (LA) consumption related to the total amount which is used throughout the procedure
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
maternal satisfaction is via likert scale with 1 is very dissatisfied and 5 is very satisfied
Time frame: From enrollment to the removal of epidural catheter
compare the incidence of breakthrough pain requiring clinician bolus in PIEB plus PCEA versus CEI plus PCEA
comparing number of breakthrough pain which requires intervention by the clinician to give rescue bolus in between each group
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
comparing if there is any occurence of motor blockade in anytime during the study period by modified bromage scale
Time frame: after epidural catheter insertion until the removal of epidural catheter
Plan to share: Undecided — 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
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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