[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628144":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":37,"studyPopulation":38,"armGroups":39,"interventions":33,"overallOfficials":33,"centralContacts":52,"locations":58,"responsibleParty":72,"collaborators":33,"id":76,"slug":33,"hasResults":77,"nctId":78,"briefTitle":79,"officialTitle":80,"acronym":33,"eligibilityCriteria":81,"healthyVolunteers":82,"sex":83,"minAge":84,"maxAge":85,"enrollmentInfo":86,"targetDuration":33,"studyType":89,"phases":33,"briefSummary":90,"conditions":91,"keywords":95,"overallStatus":103,"whyStopped":33,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":108,"completionDateStruct":110,"leadSponsor":112,"locationsCount":113},{"fullName":5,"class":6},"Tomas Bata Hospital, Czech Republic","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":33},[9],{"measure":10,"description":11,"timeFrame":12},"Postoperative pain intensity","Pain intensity will be assessed using the Visual Analog Scale (VAS) or Numerical Rating Scale (NRS) at predefined postoperative intervals. Both scales range from 0 to 10, where 0 indicates no pain and 10 indicates the worst pain imaginable.\n\nHigher scores represent worse pain intensity.","6 hours, 24 hours, and 48 hours after surgery",[14,18,21,25,29],{"measure":15,"description":16,"timeFrame":17},"Analgesic consumption","Total opioid and non-opioid analgesic dose administered within 48 hours postoperatively.","First 48 hours after surgery",{"measure":19,"description":20,"timeFrame":17},"Adverse effects","Incidence of nausea, vomiting, urinary retention, hypotension, and other analgesia-related adverse events.",{"measure":22,"description":23,"timeFrame":24},"Patient satisfaction","Patient satisfaction with pain control and overall care will be assessed using a 5-point Likert scale, ranging from 1 to 5, where 1 indicates very low satisfaction and 5 indicates very high satisfaction. Higher scores represent better satisfaction.","48 hours after surgery",{"measure":26,"description":27,"timeFrame":28},"Length of hospital stay","Length of hospital stay will be measured as the number of days from the date of surgery until the date of hospital discharge","From the day of surgery (Day 0) through hospital discharge (typically 3-14 days).",{"measure":30,"description":31,"timeFrame":32},"Number of participants requiring therapeutic interventions","The need for therapeutic interventions will be recorded, including additional analgesia, intravenous fluids, vasopressors, or other supportive measures administered due to insufficient pain control or hemodynamic instability.","Up to 48 hours after surgery.",null,{"allocation":33,"interventionModel":33,"interventionModelDescription":33,"primaryPurpose":33,"observationalModel":35,"timePerspective":36,"maskingInfo":33},"COHORT","PROSPECTIVE","This prospective, monocentric observational study evaluates postoperative pain intensity and analgesic consumption in adult patients undergoing primary total knee arthroplasty (TKA). The study focuses on anesthesia techniques routinely used in clinical practice, including general anesthesia with peripheral nerve block, general anesthesia with an epidural catheter, spinal anesthesia with peripheral nerve block, and spinal anesthesia alone.\n\nThe primary methodological aim is to compare postoperative pain trajectories (NRS) and total analgesic use during the first 48 hours after surgery across anesthesia strategies. Secondary observations include adverse effects related to analgesia, patient satisfaction, and the need for therapeutic interventions such as fluid administration, vasopressors, antiemetics, or adjustments in analgesic regimen.\n\nIndependent variables include type of anesthesia, ASA physical status, age, sex, BMI, type of peripheral nerve block, and duration of surgery. Dependent variables include postoperative pain scores, analgesic consumption, adverse events, and patient-reported satisfaction.\n\nThe study is designed to identify clinically relevant differences in postoperative pain control and to explore factors associated with hypotension and other perioperative complications. Findings may support optimization of perioperative analgesia and guide clinical decision-making in anesthesia management for TKA.","Adult patients aged 18-100 years undergoing primary total knee arthroplasty at Krajská nemocnice T. Bati, a. s. Patients must have ASA physical status I-III, GCS 15, ability to understand the study procedures, and provide informed consent. Only patients capable of cooperation during pre-anesthetic evaluation and without severe sensory impairment are included.",[40,43,46,49],{"label":41,"type":33,"description":42,"interventionNames":33},"General Anesthesia + Peripheral Nerve Block (CA + PNB)","Patients undergoing total knee arthroplasty under general anesthesia combined with a peripheral nerve block. General anesthesia is induced using intravenous and inhalational agents. A peripheral nerve block (most commonly femoral or saphenous) is administered preoperatively to reduce postoperative pain and opioid requirements. This group represents a commonly used multimodal analgesic approach in routine clinical practice.",{"label":44,"type":33,"description":45,"interventionNames":33},"General Anesthesia + Epidural Catheter (CA + EDA)","Patients undergoing total knee arthroplasty under general anesthesia with an epidural catheter placed for intraoperative and postoperative analgesia. General anesthesia is induced using intravenous and inhalational agents. The epidural catheter allows continuous administration of analgesics and individualized dose adjustment to maintain postoperative pain control. This group represents a commonly used technique for providing extended regional analgesia following TKA.",{"label":47,"type":33,"description":48,"interventionNames":33},"Spinal Anesthesia + Peripheral Nerve Block (SA + PNB)","Patients undergoing total knee arthroplasty under spinal anesthesia supplemented with a peripheral nerve block. Spinal anesthesia is administered into the subarachnoid space to provide intraoperative analgesia. A peripheral nerve block (femoral or saphenous) is added to enhance postoperative pain control and reduce the need for systemic analgesics. This combination represents a commonly used multimodal analgesic strategy.",{"label":50,"type":33,"description":51,"interventionNames":33},"Spinal Anesthesia (SA)","Patients receiving spinal anesthesia alone without an additional peripheral nerve block. Spinal anesthesia provides sensory and motor blockade of the lower body during surgery. This group allows evaluation of postoperative pain and analgesic requirements in patients managed with spinal anesthesia as the sole regional technique.",[53],{"name":54,"role":55,"phone":56,"phoneExt":33,"email":57},"Klára Nekvindová, MD, Ph.D.","CONTACT","+420 577 552 111","nekvindova.klara@gmail.com",[59],{"facility":60,"status":33,"city":61,"state":33,"zip":62,"country":63,"countryCode":33,"cosmosGeoPoint":64,"geoPoint":69,"contacts":70},"Tomas Bata regional hospital","Zlín","76001","Czechia",{"type":65,"coordinates":66},"Point",[67,68],17.67065,49.22645,{"lat":68,"lon":67},[71],{"name":54,"role":55,"phone":56,"phoneExt":33,"email":33},{"type":73,"investigatorFullName":74,"investigatorTitle":75,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"PRINCIPAL_INVESTIGATOR","Klára Nekvindová","Clinical Research Lead, omas Bata Hospital","100628144",false,"NCT07457814","Postoperative Pain and Analgesic Use After Total Knee Arthroplasty","Postoperative Pain and Analgesic Consumption in Patients Undergoing Total Knee Arthroplasty Under General Anesthesia With Peripheral Nerve Block Versus Spinal Anesthesia With Peripheral Nerve Block","Inclusion Criteria:\n\n* Age 18-100 years\n* Primary total knee arthroplasty (TKA)\n* ASA physical status I-III\n* Glasgow Coma Scale (GCS) score of 15\n* Ability to understand study procedures and provide informed consent\n* Ability to cooperate during pre-anesthetic evaluation\n* No severe sensory impairment (e.g., blindness, deafness)\n\nExclusion Criteria:\n\n* Revision or reoperation of TKA\n* ASA score IV or higher\n* Refusal to participate or inability to provide informed consent\n* GCS ≤ 14\n* Limited legal capacity\n* Active psychiatric disorder\n* Chronic use of strong opioid analgesics\n* Neurological disease affecting pain perception or cooperation\n* Cognitive impairment or language barrier preventing questionnaire completion\n* Use of anesthesia techniques other than GA + PNB or SA + PNB (e.g., epidural anesthesia, local infiltration without PNB)",true,"ALL","18 Years","100 Years",{"count":87,"type":88},50,"ESTIMATED","OBSERVATIONAL","This prospective observational study evaluates postoperative pain intensity and analgesic consumption in patients undergoing total knee arthroplasty (TKA) under different anesthesia techniques. Patients receive either general anesthesia with peripheral nerve block, spinal anesthesia with peripheral nerve block, spinal anesthesia alone, or general anesthesia with an epidural catheter. Pain scores (NRS), analgesic use, adverse effects, patient satisfaction, and the need for therapeutic interventions are assessed during the first 48 hours after surgery. The study aims to identify differences in postoperative pain control and factors associated with hypotension and other complications.",[92,93,94],"Postoperative Pain After Total Knee Arthroplasty","Postoperative Pain","Analgesic Consumption",[96,93,97,94,98,99,100,101,102],"Total Knee Arthroplasty","Anesthesia Techniques","Epidural Analgesia","Opioid Use","General Anesthesia","Spinal Anesthesia","Pain Management","NOT_YET_RECRUITING","2026-03-04",{"date":106,"type":107},"2026-03-09","ACTUAL",{"date":109,"type":88},"2026-03-01",{"date":111,"type":88},"2027-06-15",{"name":5,"class":6},1]