[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100480358":3},{"organization":4,"armGroups":7,"interventions":63,"overallOfficials":101,"centralContacts":106,"locations":118,"responsibleParty":134,"collaborators":116,"id":137,"slug":138,"hasResults":139,"nctId":140,"briefTitle":141,"officialTitle":142,"acronym":143,"eligibilityCriteria":144,"healthyVolunteers":139,"sex":145,"minAge":146,"maxAge":147,"enrollmentInfo":148,"targetDuration":116,"studyType":151,"phases":152,"briefSummary":154,"conditions":155,"keywords":116,"overallStatus":120,"whyStopped":116,"lastUpdateSubmitDate":159,"lastUpdatePostDateStruct":160,"startDateStruct":163,"completionDateStruct":165,"leadSponsor":167,"locationsCount":168},{"fullName":5,"class":6},"Ciusss de L'Est de l'Île de Montréal","OTHER",[8,14,19,24,29,34,39,43,47,51,55,59],{"label":9,"type":10,"description":11,"interventionNames":12},"F5 ml PIEB","EXPERIMENTAL","Female patients in this group will receive a 5 ml PIEB every 60 minutes of bupivacaine 0,05% + fentanyl 2mcg\u002Fml + epinephrine 2mcg\u002Fml.",[13],"Drug: Programmed intermittent epidural bolus 5 ml",{"label":15,"type":10,"description":16,"interventionNames":17},"F6 ml PIEB","Female patients in this group will receive a 6 ml PIEB every 60 minutes of bupivacaine 0,05% + fentanyl 2mcg\u002Fml + epinephrine 2mcg\u002Fml.",[18],"Drug: Programmed intermittent epidural bolus 6 ml",{"label":20,"type":10,"description":21,"interventionNames":22},"F7 ml PIEB","Female patients in this group will receive a 7 ml PIEB every 60 minutes of bupivacaine 0,05% + fentanyl 2mcg\u002Fml + epinephrine 2mcg\u002Fml.",[23],"Drug: Programmed intermittent epidural bolus 7 ml",{"label":25,"type":10,"description":26,"interventionNames":27},"F8 ml PIEB","Female patients in this group will receive a 8 ml PIEB every 60 minutes of bupivacaine 0,05% + fentanyl 2mcg\u002Fml + epinephrine 2mcg\u002Fml.",[28],"Drug: Programmed intermittent epidural bolus 8 ml",{"label":30,"type":10,"description":31,"interventionNames":32},"F9 ml PIEB","Female patients in this group will receive a 9 ml PIEB every 60 minutes of bupivacaine 0,05% + fentanyl 2mcg\u002Fml + epinephrine 2mcg\u002Fml.",[33],"Drug: Programmed intermittent epidural bolus 9 ml",{"label":35,"type":10,"description":36,"interventionNames":37},"F10 ml PIEB","Female patients in this group will receive a 10 ml PIEB every 60 minutes of bupivacaine 0,05% + fentanyl 2mcg\u002Fml + epinephrine 2mcg\u002Fml.",[38],"Drug: Programmed intermittent epidural bolus 10 ml",{"label":40,"type":10,"description":41,"interventionNames":42},"M5 ml PIEB","Male patients in this group will receive a 5 ml PIEB every 60 minutes of bupivacaine 0,05% + fentanyl 2mcg\u002Fml + epinephrine 2mcg\u002Fml.",[13],{"label":44,"type":10,"description":45,"interventionNames":46},"M6 mL PIEB","Male patients in this group will receive a 6 ml PIEB every 60 minutes of bupivacaine 0,05% + fentanyl 2mcg\u002Fml + epinephrine 2mcg\u002Fml.",[18],{"label":48,"type":10,"description":49,"interventionNames":50},"M7 mL PIEB","Male patients in this group will receive a 7 ml PIEB every 60 minutes of bupivacaine 0,05% + fentanyl 2mcg\u002Fml + epinephrine 2mcg\u002Fml.",[23],{"label":52,"type":10,"description":53,"interventionNames":54},"M8 mL PIEB","Male patients in this group will receive a 8 ml PIEB every 60 minutes of bupivacaine 0,05% + fentanyl 2mcg\u002Fml + epinephrine 2mcg\u002Fml.",[28],{"label":56,"type":10,"description":57,"interventionNames":58},"M9 mL PIEB","Male patients in this group will receive a 9 ml PIEB every 60 minutes of bupivacaine 0,05% + fentanyl 2mcg\u002Fml + epinephrine 2mcg\u002Fml.",[33],{"label":60,"type":10,"description":61,"interventionNames":62},"M10 mL PIEB","Male patients in this group will receive a 10 ml PIEB every 60 minutes of bupivacaine 0,05% + fentanyl 2mcg\u002Fml + epinephrine 2mcg\u002Fml.",[38],[64,71,77,83,89,95],{"type":65,"name":66,"description":67,"armGroupLabels":68,"otherNames":69},"DRUG","Programmed intermittent epidural bolus 5 ml","patients in this group will receive a programmed epidural intermittent bolus of 5 mL every 60 min. Patients will also be allowed patient controlled epidural boluses of 5 ml, every 30 min, as needed to treat pain \\> 4\u002F10",[9,40],[70],"5 mL",{"type":65,"name":72,"description":73,"armGroupLabels":74,"otherNames":75},"Programmed intermittent epidural bolus 6 ml","patients in this group will receive a programmed epidural intermittent bolus of 6 mL every 60 min. Patients will also be allowed patient controlled epidural boluses of 5 ml, every 30 min, as needed to treat pain \\> 4\u002F10",[15,44],[76],"6 mL",{"type":65,"name":78,"description":79,"armGroupLabels":80,"otherNames":81},"Programmed intermittent epidural bolus 7 ml","patients in this group will receive a programmed epidural intermittent bolus of 7 mL every 60 min. Patients will also be allowed patient controlled epidural boluses of 5 ml, every 30 min, as needed to treat pain \\> 4\u002F10",[20,48],[82],"7 mL",{"type":65,"name":84,"description":85,"armGroupLabels":86,"otherNames":87},"Programmed intermittent epidural bolus 8 ml","patients in this group will receive a programmed epidural intermittent bolus of 8 mL every 60 min. Patients will also be allowed patient controlled epidural boluses of 5 ml, every 30 min, as needed to treat pain \\> 4\u002F10",[25,52],[88],"8 mL",{"type":65,"name":90,"description":91,"armGroupLabels":92,"otherNames":93},"Programmed intermittent epidural bolus 9 ml","patients in this group will receive a programmed epidural intermittent bolus of 9 mL every 60 min. Patients will also be allowed patient controlled epidural boluses of 5 ml, every 30 min, as needed to treat pain \\> 4\u002F10",[30,56],[94],"9 mL",{"type":65,"name":96,"description":97,"armGroupLabels":98,"otherNames":99},"Programmed intermittent epidural bolus 10 ml","patients in this group will receive a programmed epidural intermittent bolus of 10 mL every 60 min. Patients will also be allowed patient controlled epidural boluses of 5 ml, every 30 min, as needed to treat pain \\> 4\u002F10",[35,60],[100],"10 mL",[102],{"name":103,"affiliation":104,"role":105},"veronique Brulotte, MD","Maisonneuve-Rosemont Hospital","PRINCIPAL_INVESTIGATOR",[107,113],{"name":108,"role":109,"phone":110,"phoneExt":111,"email":112},"Veronique Brulotte, MD","CONTACT","514252-3400","4558","veronique.brulotte@umontreal.ca",{"name":114,"role":109,"phone":115,"phoneExt":116,"email":117},"Nadia Godin, RN","514 252-3400",null,"ngodin.hmr@ssss.gouv.qc.ca",[119],{"facility":104,"status":120,"city":121,"state":122,"zip":123,"country":124,"countryCode":125,"cosmosGeoPoint":126,"geoPoint":131,"contacts":132},"RECRUITING","Montreal","Quebec","H1T2m4","Canada","CA",{"type":127,"coordinates":128},"Point",[129,130],-73.58781,45.50884,{"lat":130,"lon":129},[133],{"name":108,"role":109,"phone":116,"phoneExt":116,"email":112},{"type":105,"investigatorFullName":135,"investigatorTitle":136,"investigatorAffiliation":104,"oldNameTitle":116,"oldOrganization":116},"Veronique Brulotte","Principal Investigator","100480358","pib-for-post-operative-analgesia-after-laparotomy--determining-the-optimum-dose-100480358",false,"NCT05534945","PIB for Post-operative Analgesia After Laparotomy : Determining the Optimum Dose","Programmed Intermittent Epidural Bolus for Postoperative Analgesia After Laparotomy: Determining the Optimum Dose Using a Biaised Coin Up-and-down Sequential Allocation Protocol","PIBDOSE","Inclusion Criteria:\n\n* 18-85 years old\n* ASA I to III\n\nExclusion Criteria:\n\n* Contraindication to TEA: Coagulopathy, sepsis or local infection at the epidural insertion site, patient refusal\n* Inability to site the epidural catheter\n* Inability to use PCEA\u002FCommunication barrier\n* Daily opioid use\n* Planned postoperative admission to the intensive care unit\n* Patient refusal\n* Predefined criteria for exclusion after inclusion: Failure to obtain a sensory block to ice in the Post Anesthesia Care Unit (PACU)(see Methods), Reoperation within 1 postoperative day","ALL","18 Years","85 Years",{"count":149,"type":150},60,"ESTIMATED","INTERVENTIONAL",[153],"NA","Pain control after surgery is a crucial component of postoperative recovery. Thus, in open abdominal surgery, the use of TEA (Thoracic epidural analgesia) has become a gold standard. However, analgesia may still remain a challenge, especially in patients with large incision abdominal incisions.\n\nTo address this problem, the use of the PIEB (Programmed intermittent epidural bolus) mode has been proposed, because it offers a better spread of the epidural medication.\n\nOnly a few studies have evaluated the superiority of this PIEB mode in open abdominal surgery, yielding conflicting results. However, PIEB showed to be at least as effective in controlling pain as CEI, and clinical experience shows that it can be a valuable tool, especially in patients with a large laparotomy incision.\n\nHowever, the optimal dosage of the PIEB mode has never been determined, Furthermore, it is known whether men and women have the same dosage needs to achieve adequate analgesia since most studies have failed to account for sex-based differences in postoperative analgesia.\n\nHence, the main objective of this study will be to determine the optimal volume dose of the PIEB delivered at a fixed interval of 60 min in patients undergoing surgery using a large midline laparotomy incision. The optimal dose for male and female patients will be determined separately by evaluating men and women in two independent groups. We hypothesize that the optimal dose of the PIEB that will provide effective analgesia in 90% of patients on the first postoperative day will range between 5 and 10 mL, for both groups.\n\nThe primary outcome in both groups is successful analgesia. It is defined as a requirement of 5 or less patient-controlled epidural boluses between 8 AM and 8 PM on the first postoperative day.\n\nSecondary outcomes will be the incidence of motor block and hypotension, comparison of the level of sensory block according to group, comparison of patient satisfaction according to group and comparison of Quality of Recovery-15 score at 48h post-op according to group.",[156,157,158],"Acute Post Operative Pain","Laparotomy","Epidural Analgesia","2025-11-13",{"date":161,"type":162},"2025-11-14","ACTUAL",{"date":164,"type":162},"2022-12-01",{"date":166,"type":150},"2026-12",{"name":5,"class":6},1]