[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100581463":3},{"organization":4,"outcomesModule":7,"designInfo":39,"detailedDescription":49,"studyPopulation":38,"armGroups":50,"interventions":61,"overallOfficials":38,"centralContacts":67,"locations":75,"responsibleParty":93,"collaborators":38,"id":97,"slug":38,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":100,"acronym":38,"eligibilityCriteria":101,"healthyVolunteers":102,"sex":103,"minAge":38,"maxAge":38,"enrollmentInfo":104,"targetDuration":38,"studyType":107,"phases":108,"briefSummary":110,"conditions":111,"keywords":38,"overallStatus":78,"whyStopped":38,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"The Rotunda Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":38},[9],{"measure":10,"description":11,"timeFrame":12},"Composite outcome: Failure of Labour epidural catheter or PIEB protocol","Composite outcome of 1\u002FFailure to insert labour epidural at the assigned level OR 2\u002F Labour epidural catheter requires resiting OR 3\u002F Healthcare worker top up due to pain OR 4\u002F Failure of epidural conversion to epidural anaesthesia if caesarean section required","During labour",[14,18,22,26,30,34],{"measure":15,"description":16,"timeFrame":17},"Pain score","Pain scores taken 60 minutes after insertion of epidural catheter and retrospective pain scores assessed during second stage of labour taken at follow up visit. Pain scores to be assessed using a visual analogue score of 0-10, where 0 is no pain at all and 10 is the worst pain.","60 minutes post delivery and at postnatal follow up.",{"measure":19,"description":20,"timeFrame":21},"Dermatomal sensory level assessed using cold sensation","Dermatomal sensory level assessed 60 minutes after insertion of the epidural catheter using ice. Assessed by placing ice at the L1 dermatome, and move cranially or caudally until the patient notices a change in cold sensation.","60 minutes after insertion of the epidural catheter",{"measure":23,"description":24,"timeFrame":25},"Bromage score","Motor block assessed at 60 minutes","60 minutes after insertion of labour epidural catheter",{"measure":27,"description":28,"timeFrame":29},"Patient Satisfaction","Patient satisfaction assessed at follow up visit, assessed using a scale of 0-10 where 0 is extremely dissatisfied and 10 is extremely satisfied.","At follow up visit within 24 hours",{"measure":31,"description":32,"timeFrame":33},"Depth of the epidural space","The depth to the epidural space in cm","At time of insertion",{"measure":35,"description":36,"timeFrame":37},"Difficulty of epidural insertion","Difficulty of epidural insertion as perceived by the clinican, on a scale on 1-4 where 1 is easy and 4 is very difficult.","At time of epidural insertion",null,{"allocation":40,"interventionModel":41,"interventionModelDescription":42,"primaryPurpose":43,"observationalModel":38,"timePerspective":38,"maskingInfo":44},"RANDOMIZED","PARALLEL","This is a prospective randomised study where women will be randomised to a high or low epidural catheter to determine which is superior for maternal analgesia efficacy and satisfaction.\n\nRandomised to intervention 'high epidural' or 'low epidural' groups. Within these groups there are two subgroups based on the specific lumbar vertebral level; high epidural (L 1,2 or L 2,3 levels) and low epidural (L 3,4 or L 4,5 levels).","TREATMENT",{"masking":45,"maskingDescription":38,"whoMasked":46},"DOUBLE",[47,48],"PARTICIPANT","CARE_PROVIDER","Epidural analgesia is widely used in different types of surgeries and procedures. Pregnant women in labour compromise the single largest group benefiting from epidural analgesia. During first stage of labour (dilatation of the cervix), an epidural should cover the sensory dermatomes from T10 to L1 to achieve a good pain relief. In the second stage of labour (descent of the baby through the cervical canal), pain is mediated via S2-S4 nerve roots. Accordingly, labour epidurals are commonly placed at the lower lumbar (L3-L4) interspace.1 A study was conducted by Moore et al., comparing high vs low lumbar epidural, showed that lower epidurals provide superior perineal analgesia, when used with a patient-controlled epidural analgesia (PCEA) infusion with continuous epidural infusion (CEI), but provided less pain relief early in labour. Another study, a metanalysis showed that another mode of delivery of the local anaesthetics is more effective; which is the Programmed Intermittent Epidural Boluses (PIEB) with PCEA. The incidence of breakthrough pain, the rates of local anaesthetic usage were significantly reduced, the labour duration was statistically shorter, and the maternal satisfaction score was significantly improved in the PIEB + PCEA group compared with that in the CEI + PCEA group.\n\nThis is a prospective randomised study where women will be randomised to a high or low epidural catheter to determine which is superior for maternal analgesia efficacy and satisfaction.\n\nRandomised to intervention 'high epidural' or 'low epidural' groups. Within these groups there are two subgroups based on the specific lumbar vertebral level; high epidural (L 1,2 or L 2,3 levels) and low epidural (L 3,4 or L 4,5 levels).",[51,57],{"label":52,"type":53,"description":54,"interventionNames":55},"Epidural analgesia performed at a higher lumbar epidural level","ACTIVE_COMPARATOR","Epidural analgesia performed using Programmed Intermittent Epidural Boluses using an epidural catheter at a higher lumbar epidural level sited at L1,L2 or L2,L3",[56],"Procedure: Epidural Analgesia",{"label":58,"type":53,"description":59,"interventionNames":60},"Epidural analgesia performed at a lower lumbar epidural level","Epidural analgesia performed using Programmed Intermittent Epidural Boluses using an epidural catheter sited at lower epidural level (L3,L4 or L4,L5)",[56],[62],{"type":63,"name":64,"description":65,"armGroupLabels":66,"otherNames":38},"PROCEDURE","Epidural Analgesia","Labour epidural analgesia",[52,58],[68,73],{"name":69,"role":70,"phone":71,"phoneExt":38,"email":72},"Thomas Drew, FCAI","CONTACT","018171753","tdrew@rotunda.ie",{"name":74,"role":70,"phone":38,"phoneExt":38,"email":38},"Mohamed Mostafa",[76],{"facility":77,"status":78,"city":79,"state":79,"zip":80,"country":81,"countryCode":82,"cosmosGeoPoint":83,"geoPoint":88,"contacts":89},"The Rotunda Hospital, Dublin","RECRUITING","Dublin","D06X898","Ireland","IE",{"type":84,"coordinates":85},"Point",[86,87],-6.24889,53.33306,{"lat":87,"lon":86},[90],{"name":91,"role":70,"phone":92,"phoneExt":38,"email":72},"Thomas Drew Consultant Anaesthetist, MbBChBAO","01 8171753",{"type":94,"investigatorFullName":95,"investigatorTitle":96,"investigatorAffiliation":5,"oldNameTitle":38,"oldOrganization":38},"PRINCIPAL_INVESTIGATOR","Tom Drew","Principal Investigator and Consultant Anaesthesiologist","100581463",false,"NCT06850636","Higher vs Lower Lumber Epidural Catheter Insertion During Labour: A Randomised Trial to Compare Efficacy.","Inclusion Criteria:\n\nWomen electing to have epidural analgesia in labour\n\nExclusion Criteria:\n\nKnown contraindication to epidural analgesia. Neurological illness Multiple gestation Fetal abnormalities In distress or requiring immediate epidural catheter placement",true,"FEMALE",{"count":105,"type":106},162,"ESTIMATED","INTERVENTIONAL",[109],"NA","This study will randomise pregnant women to labour epidural at a higher versus a lower lumbar level. Outcomes relating to success or failure of the epidural catheter at this level will be assessed.",[112],"Labour Analgesia, Epidural Anaesthesia","2025-04-02",{"date":115,"type":116},"2025-04-03","ACTUAL",{"date":118,"type":116},"2025-02-25",{"date":120,"type":106},"2025-09",{"name":5,"class":6},1]