[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100657529":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":23,"studyPopulation":23,"armGroups":30,"interventions":45,"overallOfficials":63,"centralContacts":67,"locations":77,"responsibleParty":90,"collaborators":23,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":23,"eligibilityCriteria":100,"healthyVolunteers":96,"sex":101,"minAge":23,"maxAge":102,"enrollmentInfo":103,"targetDuration":23,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":23,"overallStatus":113,"whyStopped":23,"lastUpdateSubmitDate":114,"lastUpdatePostDateStruct":115,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},{"fullName":5,"class":6},"Nationwide Children's Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":23},[9],{"measure":10,"description":11,"timeFrame":12},"Postoperative pain score","Average pain score after surgery on a scale of 0-10. Zero being no pain and 10 being the worst pain imaginable.","72 hours after surgery",[14,17,20],{"measure":15,"description":16,"timeFrame":12},"Postoperative opioid consumption","Cumulative postoperative opioid consumption in morphine millequivalents.",{"measure":18,"description":19,"timeFrame":12},"Epidural leakage","Incidence of local anesthetic leaking from epidural.",{"measure":21,"description":22,"timeFrame":12},"Hypotension","Incidence of postoperative hypotension requiring intervention.",null,{"allocation":25,"interventionModel":26,"interventionModelDescription":23,"primaryPurpose":27,"observationalModel":23,"timePerspective":23,"maskingInfo":28},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":29,"maskingDescription":23,"whoMasked":23},"NONE",[31,38],{"label":32,"type":33,"description":34,"interventionNames":35},"Continuous epidural infusion (CEI)","ACTIVE_COMPARATOR","A continuous infusion of anesthetic medication through an epidural catheter.",[36,37],"Drug: Ropivacaine (Epidural analgesia) continuous infusion","Drug: Chloroprocaine continuous infusion",{"label":39,"type":40,"description":41,"interventionNames":42},"Programmed intermittent epidural bolus (PIEB)","EXPERIMENTAL","Administering boluses of anesthetic medication through an epidural catheter on a scheduled interval without patient involvement.",[43,44],"Drug: Ropivacaine (Epidural analgesia) intermittent bolus","Drug: Chloroprocaine intermittent bolus",[46,51,55,59],{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":23},"DRUG","Ropivacaine (Epidural analgesia) intermittent bolus","Actual body weight greater than 15 kg: 0.2% ropivacaine 0.2 mL\u002Fkg every 60 minutes",[39],{"type":47,"name":52,"description":53,"armGroupLabels":54,"otherNames":23},"Ropivacaine (Epidural analgesia) continuous infusion","Actual body weight greater than 15 kg: 0.2% ropivacaine 0.2 ml\u002Fkg\u002Fhr",[32],{"type":47,"name":56,"description":57,"armGroupLabels":58,"otherNames":23},"Chloroprocaine intermittent bolus","Actual body weight less than or equal to 15 kg: 1.5% 2-chloroprocaine 0.25 ml\u002Fkg every 30 minutes",[39],{"type":47,"name":60,"description":61,"armGroupLabels":62,"otherNames":23},"Chloroprocaine continuous infusion","Actual body weight less than or equal to 15 kg: 1.5% 2-chloroprocaine 0.5 ml\u002Fkg\u002Fhr",[32],[64],{"name":65,"affiliation":5,"role":66},"Giorgio Veneziano, MD","PRINCIPAL_INVESTIGATOR",[68,73],{"name":69,"role":70,"phone":71,"phoneExt":23,"email":72},"Julie Rice-Weimer, BSN","CONTACT","614-355-3142","julie.rice-weimer@nationwidechildrens.org",{"name":74,"role":70,"phone":75,"phoneExt":23,"email":76},"Catherine Roth, MPH","614-722-2997","catherine.roth@nationwidechildrens.org",[78],{"facility":5,"status":23,"city":79,"state":80,"zip":81,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":23},"Columbus","Ohio","43205","United States","US",{"type":85,"coordinates":86},"Point",[87,88],-82.99879,39.96118,{"lat":88,"lon":87},{"type":91,"investigatorFullName":92,"investigatorTitle":93,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"SPONSOR_INVESTIGATOR","Giorgio Veneziano","Medical Director, Comprehensive Pain Services","100657529","a-pilot-study-comparison-of-programmed-intermittent-bolus-versus-continuous-infusion-100657529",false,"NCT07839039","A Pilot Study Comparison of Programmed Intermittent Bolus Versus Continuous Infusion","A Pilot Study Comparison of Postoperative Analgesia Using Two Modes of Local Anesthetic Epidural Delivery After Bladder Exstrophy Repair: Programmed Intermittent Bolus Versus Continuous Infusion","Inclusion Criteria:\n\n* Age less than 18 years\n* Kelly procedure or other approximating surgical interventions\n* Expected need for postoperative epidural analgesia of at least 72 hours in duration\n\nExclusion Criteria:\n\n* Spine abnormality or coagulopathy that contraindicates epidural catheter placement\n* Perioperative anticoagulation regimen that is not recommended by the ASRA guidelines on concurrent use with neuraxial anesthesia\n* Surgery is anticipated to require osteotomies\n* Allergy to local anesthetic drug or other pain management drugs listed in protocol\n* Allergy to chlorhexidine, Dermabond, or Tegaderm CHG dressing\n* Opioid consumption within two weeks prior to surgery\n* Infection or rash over the epidural catheter insertion site\n* Systemic bacterial or fungal infection requiring ongoing treatment with antibiotics\n* Epidural pump unable to be initiated in the operating room or within 30 minutes of arrival to PACU.","ALL","18 Years",{"count":104,"type":105},10,"ESTIMATED","INTERVENTIONAL",[108],"NA","The purpose of this study is to determine whether programmed intermittent epidural bolus (PIEB) offers advantages over continuous epidural infusion (CEI) in this pediatric post-surgical population by randomizing patients to receive either the PIEB or CEI pump modality for postoperative analgesia. The comparative efficacy of the two interventions will be primarily determined by assessing pain scores at frequent intervals in the first three postoperative days. Secondary outcomes examined over this period will include opioid consumption, number of epidural pump interventions, incidence of epidural insertion site leakage and\u002For early catheter discontinuation, time to full diet, and incidence of postoperative hypotension.",[111,112],"Bladder Extrophy","Surgery in Children","NOT_YET_RECRUITING","2026-09-24",{"date":116,"type":117},"2026-09-28","ACTUAL",{"date":119,"type":105},"2026-11",{"date":121,"type":105},"2028-12",{"name":92,"class":6},1]