[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584434":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":50,"collaborators":25,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":25,"eligibilityCriteria":60,"healthyVolunteers":56,"sex":61,"minAge":62,"maxAge":25,"enrollmentInfo":63,"targetDuration":25,"studyType":66,"phases":67,"briefSummary":69,"conditions":70,"keywords":25,"overallStatus":72,"whyStopped":25,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"Hospital Universiti Sains Malaysia","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Continuous Epidural Analgesia","EXPERIMENTAL","Epidural catheter will be connected to epidural cocktail (Bupivacaine 0.1% + Fentanyl 2mcg\u002Fml in 50ml mixture) with the protocol as below: (directly extracted from Malaysia Pain management in Obstetrics and Gynaecology Procedure Guideline 2023)\n\n* Loading dose 10 ml\n* Continuous infusion: 10ml\u002Fhour",[13],"Procedure: Continuos epidural infusion",{"label":15,"type":10,"description":16,"interventionNames":17},"Programmed Intermittent Epidural Bolus","Patient in this group receive programmed intermittent epidural bolus (PIEB) using cocktail of Ropivacaine 0.05% + fentanyl 2mcg\u002Fml, with 10ml cocktail loading when started, then 10ml hourly bolus, with patient controlled epidural analgesia (PCEA) - 10ml per patient request, lockout interval 10minutes.",[18],"Procedure: Programmed intermittent epidural bolus",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Continuos epidural infusion","This group of parturient will be inserted epidural catheter at L3\u002FL4 or L4\u002FL5 depending on anaesthetist-in-charge justification, epidural catheter will be kept 4-5 cm in epidural space and anchored with adhesive tape. Similarly, a test dose of LA Lignocaine 2% 2ml will be given after epidural insertion. Infusion tubing will be primed in advance. Epidural catheter will be connected to epidural cocktail (Bupivacaine 0.1% + Fentanyl 2mcg\u002Fml in 50ml mixture) with the protocol as below: (directly extracted from Malaysia Pain management in Obstetrics and Gynaecology Procedure Guideline 2023)\n\n* Loading dose 10 ml\n* Continuous infusion: 10ml\u002Fhour",[9],null,{"type":21,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Programmed intermittent epidural bolus","This group patient will be inserted epidural catheter at L3\u002FL4 or L4\u002FL5 depending on anaesthetist-in-charge justification, epidural catheter will be kept 4-5 cm in epidural space and anchored with adhesive tape. A test dose of LA Lignocaine 2% 2ml will be given after epidural insertion. CADD-Solis infusion tubing will be primed in advance. Epidural catheter will be connected to epidural cocktail (Ropivacaine 0.05% + Fentanyl 2mcg\u002Fml in 100ml mixture) with the protocol as below:\n\n* Loading dose: 10ml\n* Intermittent bolus: 10ml, bolus interval 1 hour, next bolus 1 hour\n* PCEA dose: 10ml, lockout interval 10 minutes",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Dr Koeh Shao Keong, Doctor of Medicine","CONTACT","+60169686388","keong705@gmail.com",[37],{"facility":38,"status":25,"city":39,"state":40,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":25},"Hospital Pakar Universiti Sains Malaysia","Kubang Kerian","Kelantan","16150","Malaysia","MY",{"type":45,"coordinates":46},"Point",[47,48],102.27938,6.09123,{"lat":48,"lon":47},{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Koeh Shao Keong","Dr","100584434","phase-4-comparison-of-safety-and-efficacy-between-pieb-and-cei-for-labour-epidural-analgesia-100584434",false,"NCT06889285","Comparison of Safety and Efficacy Between PIEB and CEI for Labour Epidural Analgesia","Comparison of Safety and Efficacy Between Programmed Intermittent Epidural Bolus (PIEB) and Continuous Epidural Infusion (CEI) for Labour Epidural Analgesia: a Randomized Controlled Trial","Inclusion Criteria:\n\n* age \\> 18 years old\n* ASA 2 \\& 3w\n\nExclusion Criteria:\n\n* patient refusal\n* significant comorbiddities, eg patient with heart disease, kidney diseae, neurological disoder\n* contraindicated to neuraxial blockade\n* allergic to local anesthetic agent or opioid\n* obstetric complications, eg pre-eclampsia, leaking liqour, suspicious CTG\n* morbid obesity, BMI \\> 40\n* grandmultiparous ( \\> 5biths at \\> 20 weeks gestation)\n* combined spinal epidural technique for labour epidural analgesia\n* height \\\u003C 145cm","FEMALE","18 Years",{"count":64,"type":65},76,"ESTIMATED","INTERVENTIONAL",[68],"PHASE4","The goal of this clinical trial is to compare safety and efficacy of programmed intermittent epidural bolus (PEIB) and continuous epidural infusion (CEI) in parturients during active phase of labour.\n\nThe main questions aimed to answer are:\n\n* Will parturient using PIEB+PCEA has lower incidence of motor block as compared to CEI during labour?\n* Will parturient using PIEB + PCEA has lower local anaesthetic consumption (in mg\u002Fhr) as compared to CEI during labour?\n* Will parturient using PIEB + PCEA has shorter duration of second stage labour as compared to CEI?\n* Will parturient using PIEB + PCEA has better satisfaction score when compared to CEI during labour?\n\nParticipants will be randomised into PIEB group and CEI group after informed consent taken\n\n* All participants will be taken baseline demographic data, vital signs, Bromage score, cardiotocograph prior intervention\n* Labour epidural will be inserted and started on PIEB protocol or CEI protocol based on randomisation\n* Participants vital signs and Bromage score will be recorded hourly till baby delivery\n* In the end of delivery, total LA consumption and duration of second stage will be recorded\n* Within 24 hours, participants will be interviewed on their satisfaction score on labour epidural analgesia.\n\nResearchers will compare PIEB and CEI to see if PIEB has better safety and efficacy as compared to CEI in labour epidural analgesia.",[71],"Analgesia, Epidural","NOT_YET_RECRUITING","2025-03-15",{"date":75,"type":76},"2025-03-21","ACTUAL",{"date":78,"type":65},"2025-04-01",{"date":80,"type":65},"2025-12-30",{"name":5,"class":6},1]