Pregnant Women, Labour Analgesia
Conditions
Keywords
Parturient, Pregnant, PIEB, PCEA, CEI, Labour Analgesia
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.
Interventions
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
PROCEDUREcontinuous 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
Aiman Bin Ab Adzim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| compare the effectiveness of PIEB plus PCEA versus CEI plus PCEA in labour analgesia via VAS score, total LA consumption and maternal satisfaction | From enrollment to the removal of epidural catheter | Visual Analogue Scale (VAS) score with 0 for no pain and 10 for worst possible pain |
| compare the effectiveness of PIEB plus PCEA versus CEI plus PCEA in labour analgesia via total LA consumption | From enrollment to the removal of epidural catheter | total Local Anaesthesia (LA) consumption related to the total amount which is used throughout the procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | comparing number of breakthrough pain which requires intervention by the clinician to give rescue bolus in between each group |
| compare the incidence of motor blocked in PIEB plus PCEA versus CEI plus PCEA | after epidural catheter insertion until the removal of epidural catheter | comparing if there is any occurence of motor blockade in anytime during the study period by modified bromage scale |
Countries
Malaysia
Contacts
CONTACTAiman Ab Adzim
CONTACTNik Rowina Nik Mohammed
Outcome results
None listed