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

ConditionsPregnant WomenLabour Analgesia
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAiman Bin Ab Adzim

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

All pregnant female > 36 weeks of gestation

Age 18 years old and above

ASA I and II

Consented for study

Disqualifiers

Allergies to LA and opioids

Severe systemic and mental disease

Contraindication to regional analgesia

Hemodynamic instabilities

Trial design

Design model

Parallel

Treatments tested in this trial

  • Programmed intermittent epidural bolus 10 ml

    Procedure/Surgery

    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

  • continuous epidural infusion

    Procedure/Surgery

    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

Treatment groups

88 Participants
are divided into 2 treatment groups
Group A: PIEB plus PCEAActive comparator 1 intervention
Group B: CEI plus PCEAActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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
2

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
3

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

Secondary outcomes

1

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
2

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aiman Bin Ab Adzim

Lead sponsor

Universiti Putra Malaysia

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: