[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100627500":3},{"organization":4,"outcomesModule":7,"designInfo":49,"detailedDescription":60,"studyPopulation":48,"armGroups":61,"interventions":74,"overallOfficials":88,"centralContacts":93,"locations":100,"responsibleParty":117,"collaborators":48,"id":119,"slug":48,"hasResults":120,"nctId":121,"briefTitle":122,"officialTitle":123,"acronym":48,"eligibilityCriteria":124,"healthyVolunteers":120,"sex":125,"minAge":126,"maxAge":127,"enrollmentInfo":128,"targetDuration":48,"studyType":131,"phases":132,"briefSummary":134,"conditions":135,"keywords":48,"overallStatus":102,"whyStopped":48,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":146},{"fullName":5,"class":6},"Poznan University of Medical Sciences","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":48},[9],{"measure":10,"description":11,"timeFrame":12},"Systemic Inflammation Response Index (SIRI)","Systemic Inflammation Response Index (SIRI) is used as a composite marker of systemic inflammatory activation. It is calculated from peripheral venous blood samples using the formula:\n\nSIRI = (Neutrophil count × Monocyte count) \u002F Lymphocyte count All parameters are obtained from routine complete blood count (CBC) analysis and expressed in ×10⁹\u002FL.\n\nSIRI reflects the interaction between innate immune activation (neutrophils and monocytes) and adaptive immune suppression (lymphocytes). Higher SIRI values indicate greater systemic inflammatory response.","12 hours after surgery",[14,16,18,21,22,23,26,27,28,31,32,33,37,39,40,41,42,45],{"measure":10,"description":11,"timeFrame":15},"24 hours after surgery",{"measure":10,"description":11,"timeFrame":17},"48 hours after surgery",{"measure":19,"description":20,"timeFrame":12},"Aggregate Index of Systemic Inflammation (AISI)","Aggregate Index of Systemic Inflammation (AISI) is calculated as:\n\nAISI = (Neutrophil count × Monocyte count × Platelet count) \u002F Lymphocyte count All values are obtained from routine CBC and expressed in ×10⁹\u002FL. AISI integrates neutrophils, monocytes, platelets, and lymphocytes, providing a broader assessment of systemic inflammatory and immune response compared to single ratios.",{"measure":19,"description":20,"timeFrame":15},{"measure":19,"description":20,"timeFrame":17},{"measure":24,"description":25,"timeFrame":12},"Platelet Mass Index (PMI)","Platelet Mass Index (PMI) reflects total circulating platelet mass and is calculated as:\n\nPMI = Platelet count × Mean Platelet Volume (MPV) Platelet count is expressed in ×10⁹\u002FL and MPV in femtoliters (fL). PMI reflects platelet activation and thrombo-inflammatory potential, which may increase in response to surgical stress.",{"measure":24,"description":25,"timeFrame":15},{"measure":24,"description":25,"timeFrame":17},{"measure":29,"description":30,"timeFrame":12},"C-reactive Protein (CRP) Concentration","C-reactive protein (CRP) is a laboratory marker of acute systemic inflammation measured in peripheral venous blood samples.\n\nCRP concentration is expressed in mg\u002FL and determined using standard hospital laboratory methods.\n\nHigher CRP values indicate greater postoperative inflammatory response.",{"measure":29,"description":30,"timeFrame":15},{"measure":29,"description":30,"timeFrame":17},{"measure":34,"description":35,"timeFrame":36},"Postoperative Pain Intensity (NRS)","Postoperative pain intensity will be assessed using the Numerical Rating Scale (NRS), ranging from 0 to 10, where:\n\n0 = no pain 10 = worst pain imaginable Pain scores will be recorded at rest.","4 hours after surgery",{"measure":34,"description":35,"timeFrame":38},"8 hours after surgery",{"measure":34,"description":35,"timeFrame":12},{"measure":34,"description":35,"timeFrame":15},{"measure":34,"description":35,"timeFrame":17},{"measure":43,"description":44,"timeFrame":17},"Opioid Consumption","Total opioid consumption within the first 48 hours after surgery will be recorded.\n\nAll administered opioids will be converted to intravenous morphine milligram equivalents (MME) for standardization.\n\nHigher cumulative MME indicates greater analgesic requirement.",{"measure":46,"description":47,"timeFrame":17},"Time to First Rescue Analgesia","Time from completion of surgery to first administration of rescue opioid analgesia.\n\nMeasured in minutes. Shorter time indicates earlier breakthrough pain.",null,{"allocation":50,"interventionModel":51,"interventionModelDescription":48,"primaryPurpose":52,"observationalModel":48,"timePerspective":48,"maskingInfo":53},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":54,"maskingDescription":48,"whoMasked":55},"QUADRUPLE",[56,57,58,59],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","Surgical trauma induces a systemic inflammatory response characterized by neutrophilia, lymphopenia, and platelet activation. These hematologic alterations reflect the interaction between innate immune activation, stress-induced immunosuppression, and pro-thrombotic mechanisms. The modulation of this response may influence postoperative recovery and complication risk.\n\nThe Systemic Immune-Inflammation Index (SII) is calculated using the formula:\n\nSII = (Platelet count × Neutrophil count) \u002F Lymphocyte count SII integrates three components of systemic inflammation and immune regulation and is considered a more comprehensive marker than isolated ratios such as neutrophil-to-lymphocyte ratio (NLR) or platelet-to-lymphocyte ratio (PLR). Compared with NLR and PLR, SII may better reflect the balance between inflammatory activation and adaptive immune suppression in the perioperative period.\n\nRegional anesthesia techniques, including the Pericapsular Nerve Group (PENG) block, may attenuate surgical stress by reducing afferent nociceptive signaling, sympathetic activation, and subsequent activation of the inflammatory cascade. While previous studies have evaluated the impact of regional anesthesia on NLR and PLR, the influence of iPACK block with Adducto Canal Block on SII in hip arthroplasty has not been previously investigated.\n\nThe primary objective of this study is to determine whether the PENG block reduces postoperative SII levels compared with the sham block in elderly patients undergoing total hip arthroplasty under spinal anesthesia.\n\nPeripheral venous blood samples will be collected preoperatively and at predefined postoperative time points (e.g., 12, 24, and 48 hours). The primary endpoint will be postoperative SII at 24 hours or the change from baseline (ΔSII), depending on statistical analysis plan.\n\nThis study aims to determine whether motor-sparing regional anesthesia may modulate systemic inflammatory response beyond analgesic effects, potentially contributing to improved perioperative outcomes.",[62,68],{"label":63,"type":64,"description":65,"interventionNames":66},"Sham blocks","PLACEBO_COMPARATOR","iPACK block with 20ml of 0.9% sodium chloride and ACB with 20ml of 0.9% sodium chloride",[67],"Drug: sodium Chloride",{"label":69,"type":70,"description":71,"interventionNames":72},"iPACK block with ACB","ACTIVE_COMPARATOR","iPACK block with 20ml of 0.2% ropivacaine and ACB with 20ml of 0.2% ropivacaine",[73],"Drug: Ropivacaine Hydrocloride",[75,82],{"type":76,"name":77,"description":78,"armGroupLabels":79,"otherNames":80},"DRUG","sodium Chloride","After spinal anesthesia, the ultrasound-guided iPACK block will be performed with 20ml of 0.9% sodium chloride; and Adductor Canal Block will be performed with 20ml of 0.9% sodium chloride",[63],[81],"0.9% NaCl",{"type":76,"name":83,"description":84,"armGroupLabels":85,"otherNames":86},"Ropivacaine Hydrocloride","After spinal anesthesia, the ultrasound-guided iPACK block will be performed with 20ml of 0.2% ropivacaine, and the Adductor Canal Block will be performed with 20ml of 0.2% ropivacaine",[69],[87],"0.2% ropivacaine",[89],{"name":90,"affiliation":91,"role":92},"Malgorzata Reysner, MD PhD","Poznań University of Medical Sciences","STUDY_CHAIR",[94,98],{"name":90,"role":95,"phone":96,"phoneExt":48,"email":97},"CONTACT","+48 501 056 924","mreysner@ump.edu.pl",{"name":90,"role":95,"phone":99,"phoneExt":48,"email":97},"+48 61 83 10 122",[101],{"facility":5,"status":102,"city":103,"state":48,"zip":104,"country":105,"countryCode":106,"cosmosGeoPoint":107,"geoPoint":112,"contacts":113},"RECRUITING","Poznan","62-701","Poland","PL",{"type":108,"coordinates":109},"Point",[110,111],16.92993,52.40692,{"lat":111,"lon":110},[114],{"name":115,"role":95,"phone":116,"phoneExt":48,"email":97},"Malgorzata Reysner, M.D. Ph.D.","+48 61 873 83 03",{"type":118,"investigatorFullName":48,"investigatorTitle":48,"investigatorAffiliation":48,"oldNameTitle":48,"oldOrganization":48},"SPONSOR","100627500",false,"NCT07449442","SII Levels Following iPACK Block With Adductor Canal Block in Knee Arthroplasty","iPACK Block With Adductor Canal Block Mitigates Surgical Stress and Enhances Analgesia in Total Hip Arthroplasty: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Patients with ASA classification I-III\n* Aged 65-100 years\n* Who will be scheduled for hip arthroplasty under spinal anesthesia\n\nExclusion Criteria:\n\n* Patients who have a history of bleeding diathesis\n* Take anticoagulant therapy\n* History of chronic pain before surgery\n* Multiple trauma\n* patients unable to assess their pain (dementia)\n* patients operated under general anesthesia\n* patients having an infection in the region of the procedure\n* the patient who does not accept the procedure","ALL","65 Years","100 Years",{"count":129,"type":130},60,"ESTIMATED","INTERVENTIONAL",[133],"NA","This randomized controlled trial evaluates the effect of ultrasound-guided iPACK block with Adductor Canal Block (ACB) on the Systemic Immune-Inflammation Index (SII) in elderly patients undergoing total hip arthroplasty under spinal anesthesia. SII, calculated as platelet × neutrophil \u002F lymphocyte count, is used as a composite marker of perioperative inflammatory and immune response. The study investigates whether iPACK block with ACB attenuates the systemic inflammatory reaction to surgical trauma compared to sham block.",[136],"Knee Osteoarthritis","2026-05-20",{"date":139,"type":140},"2026-05-22","ACTUAL",{"date":142,"type":140},"2026-03-01",{"date":144,"type":130},"2026-06-30",{"name":5,"class":6},1]