[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100637370":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":33,"locations":39,"responsibleParty":55,"collaborators":32,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":32,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":32,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":87,"whyStopped":32,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Sakarya University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PIEB","EXPERIMENTAL","Participants will receive postoperative epidural analgesia using programmed intermittent epidural bolus (PIEB) combined with patient-controlled epidural analgesia (PCEA). The epidural solution will consist of 0.1% bupivacaine. Automatic epidural boluses of 6 mL will be delivered every 60 minutes. Patient-controlled epidural boluses of 6 mL with a 30-minute lockout interval will also be available.",[13],"Procedure: Programmed intermittent epidural bolus 6 ml",{"label":15,"type":16,"description":17,"interventionNames":18},"CEI","ACTIVE_COMPARATOR","Participants will receive postoperative epidural analgesia using continuous epidural infusion (CEI) combined with patient-controlled epidural analgesia (PCEA). The epidural solution will consist of 0.1% bupivacaine. Continuous epidural infusion will be administered at a rate of 6 mL\u002Fhour. Patient-controlled epidural boluses of 6 mL with a 30-minute lockout interval will also be available.",[19],"Procedure: continuous epidural infusion",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"PROCEDURE","Programmed intermittent epidural bolus 6 ml","Postoperative epidural analgesia delivered as programmed intermittent epidural boluses using 0.1% bupivacaine. Automatic boluses of 6 mL will be administered every 60 minutes in combination with patient-controlled epidural analgesia boluses of 6 mL with a 30-minute lockout interval.",[9],[9],{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"continuous epidural infusion","Postoperative epidural analgesia delivered as continuous epidural infusion using 0.1% bupivacaine at a rate of 6 mL\u002Fhour in combination with patient-controlled epidural analgesia boluses of 6 mL with a 30-minute lockout interval.",[15],[15],null,[34],{"name":35,"role":36,"phone":37,"phoneExt":32,"email":38},"Ahmet R Doğan, M.D","CONTACT","+905427988070","a.ridvandogan@gmail.com",[40],{"facility":41,"status":32,"city":42,"state":43,"zip":44,"country":45,"countryCode":32,"cosmosGeoPoint":46,"geoPoint":51,"contacts":52},"Sakarya University Training and Research Hospital, Department of Anesthesiology and Reanimation","Sakarya","Adapazari","54000","Turkey (Türkiye)",{"type":47,"coordinates":48},"Point",[49,50],32.07583,39.50333,{"lat":50,"lon":49},[53],{"name":54,"role":36,"phone":37,"phoneExt":32,"email":38},"AHMET R DOĞAN, M.D",{"type":56,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"PRINCIPAL_INVESTIGATOR","Ayça Taş Tuna","Prof.Dr.","100637370","programmed-intermittent-epidural-bolus-versus-continuous-epidural-infusion-for-postoperative-analgesia-after-total-knee-arthroplasty-100637370",false,"NCT07605208","Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion for Postoperative Analgesia After Total Knee Arthroplasty","Effect of Programmed Intermittent Epidural Bolus Versus Continuous Epidural Infusion on Postoperative Analgesia and Quality of Recovery After Total Knee Arthroplasty: A Prospective Randomized Double-Blind Controlled Trial","Inclusion Criteria:\n\n* Adults aged 18 to 80 years\n* American Society of Anesthesiologists (ASA) physical status I-III\n* Scheduled for elective primary total knee arthroplasty\n* Eligible for combined spinal-epidural anesthesia and postoperative epidural analgesia\n* Able to understand and use patient-controlled epidural analgesia\n* Provided written informed consent\n\nExclusion Criteria:\n\n* Refusal to participate in the study\n* Known allergy or hypersensitivity to study medications\n* Body mass index (BMI) ≥ 40 kg\u002Fm²\n* Body weight \\\u003C 40 kg\n* Severe cardiac disease, including symptomatic arrhythmia or advanced conduction abnormalities\n* Coagulopathy (INR \\> 1.5 or platelet count \\\u003C 100,000\u002Fmm³)\n* Pregnancy or breastfeeding\n* Revision total knee arthroplasty or emergency surgery\n* Active infection at the site of regional anesthesia\n* Chronic opioid use or opioid dependence\n* Neurological disease or preexisting motor\u002Fsensory deficit in the lower extremities\n* ASA physical status IV or V\n* Requirement for intraoperative epidural local anesthetic supplementation due to inadequate spinal anesthesia","ALL","18 Years","80 Years",{"count":70,"type":71},90,"ESTIMATED","INTERVENTIONAL",[74],"NA","The goal of this clinical trial is to compare two different epidural analgesia delivery methods for pain control after total knee arthroplasty in adults undergoing elective surgery. The study will evaluate whether programmed intermittent epidural bolus (PIEB) provides better postoperative analgesia and recovery outcomes than continuous epidural infusion (CEI).\n\nThe main questions it aims to answer are:\n\nDoes PIEB reduce total epidural local anesthetic consumption during the first 24 postoperative hours compared with CEI? Does PIEB improve postoperative pain control and quality of recovery? Are there differences between the two methods regarding motor block, rescue analgesic requirement, patient-controlled epidural analgesia use, and adverse effects?\n\nResearchers will compare PIEB plus patient-controlled epidural analgesia (PCEA) with CEI plus PCEA in patients undergoing total knee arthroplasty.\n\nParticipants will:\n\nReceive combined spinal-epidural anesthesia during surgery Receive postoperative epidural analgesia using either PIEB or CEI Be evaluated for pain scores, motor block, recovery quality, epidural local anesthetic consumption, rescue analgesic requirement, and adverse events during the first 24 postoperative hours",[77,78],"Total Knee Anthroplasty","Epidural Analgesia",[80,9,81,15,82,83,84,85,86],"Programmed Intermittent Epidural Bolus","Continuous Epidural Infusion","Patient-Controlled Epidural Analgesia","PCEA","Total Knee Arthroplasty","Postoperative Analgesia","QoR-15","NOT_YET_RECRUITING","2026-05-24",{"date":90,"type":91},"2026-05-28","ACTUAL",{"date":93,"type":71},"2026-06-01",{"date":95,"type":71},"2027-12-01",{"name":5,"class":6},1]