Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-30 @ 2:12 AM
Study NCT ID:
NCT07449403
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-04
First Post:
2026-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SII Levels Following PENG Block in Hip Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015207', 'term': 'Osteoarthritis, Hip'}], 'ancestors': [{'id': 'D010003', 'term': 'Osteoarthritis'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012216', 'term': 'Rheumatic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D000077212', 'term': 'Ropivacaine'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-27', 'studyFirstSubmitDate': '2026-02-27', 'studyFirstSubmitQcDate': '2026-02-27', 'lastUpdatePostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systemic Inflammation Response Index (SIRI)', 'timeFrame': '12 hours after surgery', 'description': '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) / Lymphocyte count All parameters are obtained from routine complete blood count (CBC) analysis and expressed in ×10⁹/L.\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.'}], 'secondaryOutcomes': [{'measure': 'Systemic Inflammation Response Index (SIRI)', 'timeFrame': '24 hours after surgery', 'description': '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) / Lymphocyte count All parameters are obtained from routine complete blood count (CBC) analysis and expressed in ×10⁹/L.\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.'}, {'measure': 'Systemic Inflammation Response Index (SIRI)', 'timeFrame': '48 hours after surgery', 'description': '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) / Lymphocyte count All parameters are obtained from routine complete blood count (CBC) analysis and expressed in ×10⁹/L.\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.'}, {'measure': 'Aggregate Index of Systemic Inflammation (AISI)', 'timeFrame': '12 hours after surgery', 'description': 'Aggregate Index of Systemic Inflammation (AISI) is calculated as:\n\nAISI = (Neutrophil count × Monocyte count × Platelet count) / Lymphocyte count All values are obtained from routine CBC and expressed in ×10⁹/L. AISI integrates neutrophils, monocytes, platelets, and lymphocytes, providing a broader assessment of systemic inflammatory and immune response compared to single ratios.'}, {'measure': 'Aggregate Index of Systemic Inflammation (AISI)', 'timeFrame': '24 hours after surgery', 'description': 'Aggregate Index of Systemic Inflammation (AISI) is calculated as:\n\nAISI = (Neutrophil count × Monocyte count × Platelet count) / Lymphocyte count All values are obtained from routine CBC and expressed in ×10⁹/L. AISI integrates neutrophils, monocytes, platelets, and lymphocytes, providing a broader assessment of systemic inflammatory and immune response compared to single ratios.'}, {'measure': 'Aggregate Index of Systemic Inflammation (AISI)', 'timeFrame': '48 hours after surgery', 'description': 'Aggregate Index of Systemic Inflammation (AISI) is calculated as:\n\nAISI = (Neutrophil count × Monocyte count × Platelet count) / Lymphocyte count All values are obtained from routine CBC and expressed in ×10⁹/L. AISI integrates neutrophils, monocytes, platelets, and lymphocytes, providing a broader assessment of systemic inflammatory and immune response compared to single ratios.'}, {'measure': 'Platelet Mass Index (PMI)', 'timeFrame': '12 hours after surgery', 'description': '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/L and MPV in femtoliters (fL). PMI reflects platelet activation and thrombo-inflammatory potential, which may increase in response to surgical stress.'}, {'measure': 'Platelet Mass Index (PMI)', 'timeFrame': '24 hours after surgery', 'description': '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/L and MPV in femtoliters (fL). PMI reflects platelet activation and thrombo-inflammatory potential, which may increase in response to surgical stress.'}, {'measure': 'Platelet Mass Index (PMI)', 'timeFrame': '48 hours after surgery', 'description': '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/L and MPV in femtoliters (fL). PMI reflects platelet activation and thrombo-inflammatory potential, which may increase in response to surgical stress.'}, {'measure': 'C-reactive Protein (CRP) Concentration', 'timeFrame': '12 hours after surgery', 'description': '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/L and determined using standard hospital laboratory methods.\n\nHigher CRP values indicate greater postoperative inflammatory response.'}, {'measure': 'C-reactive Protein (CRP) Concentration', 'timeFrame': '24 hours after surgery', 'description': '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/L and determined using standard hospital laboratory methods.\n\nHigher CRP values indicate greater postoperative inflammatory response.'}, {'measure': 'C-reactive Protein (CRP) Concentration', 'timeFrame': '48 hours after surgery', 'description': '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/L and determined using standard hospital laboratory methods.\n\nHigher CRP values indicate greater postoperative inflammatory response.'}, {'measure': 'Postoperative Pain Intensity (NRS)', 'timeFrame': '4 hours after surgery', 'description': '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.'}, {'measure': 'Postoperative Pain Intensity (NRS)', 'timeFrame': '8 hours after surgery', 'description': '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.'}, {'measure': 'Postoperative Pain Intensity (NRS)', 'timeFrame': '12 hours after surgery', 'description': '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.'}, {'measure': 'Postoperative Pain Intensity (NRS)', 'timeFrame': '24 hours after surgery', 'description': '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.'}, {'measure': 'Postoperative Pain Intensity (NRS)', 'timeFrame': '48 hours after surgery', 'description': '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.'}, {'measure': 'Opioid Consumption', 'timeFrame': '48 hours after surgery', 'description': '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': 'Time to First Rescue Analgesia', 'timeFrame': '48 hours after surgery', 'description': 'Time from completion of surgery to first administration of rescue opioid analgesia.\n\nMeasured in minutes. Shorter time indicates earlier breakthrough pain.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hip Osteoarthritis']}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial evaluates the effect of ultrasound-guided Pericapsular Nerve Group (PENG) block on the Systemic Immune-Inflammation Index (SII) in elderly patients undergoing total hip arthroplasty under spinal anesthesia. SII, calculated as platelet × neutrophil / lymphocyte count, is used as a composite marker of perioperative inflammatory and immune response. The study investigates whether PENG block attenuates the systemic inflammatory reaction to surgical trauma compared to sham block.', 'detailedDescription': '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) / 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 inflammatory cascade activation. While previous studies have evaluated the impact of regional anesthesia on NLR and PLR, the influence of PENG block on SII in hip arthroplasty has not been previously investigated.\n\nThe primary objective of this study is to determine whether PENG block reduces postoperative SII levels compared with 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': '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'}, 'identificationModule': {'nctId': 'NCT07449403', 'briefTitle': 'SII Levels Following PENG Block in Hip Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Poznan University of Medical Sciences'}, 'officialTitle': 'Pericapsular Nerve Group Block Mitigates Surgical Stress and Enhances Analgesia in Total Hip Arthroplasty: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '80/26'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'SHAM_COMPARATOR', 'label': 'Sham blocks', 'description': 'PENG block with 20ml of 0.9% sodium chloride', 'interventionNames': ['Drug: sodium Chloride']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PENG block', 'description': 'PENG block with 20ml 0f 0.2% ropivacaine', 'interventionNames': ['Drug: Ropivacaine 0.2% Injectable Solution']}], 'interventions': [{'name': 'sodium Chloride', 'type': 'DRUG', 'otherNames': ['0.9% Sodium Chloride Injection'], 'description': 'After spinal anesthesia, the ultrasound-guided PENG block will be performed with 20ml of 0.9% sodium chloride', 'armGroupLabels': ['Sham blocks']}, {'name': 'Ropivacaine 0.2% Injectable Solution', 'type': 'DRUG', 'otherNames': ['0.2% ropivacaine'], 'description': 'After spinal anesthesia, the ultrasound-guided PENG block will be performed with 20 ml of 0.2% ropivacaine', 'armGroupLabels': ['PENG block']}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': 'Data will become available 6 months after publication of the primary results and will remain available for 5 years.', 'ipdSharing': 'YES', 'description': 'De-identified individual participant data (IPD) underlying the results reported in publications (including demographic data, laboratory inflammatory indices such as SII, SIRI, AISI, CRP values, pain scores, opioid consumption, and time-to-event outcomes) will be made available to qualified researchers.\n\nData will be shared after removal of all direct identifiers in accordance with GDPR regulations and institutional data protection policies.\n\nThe study protocol, statistical analysis plan (SAP), and analytic code will also be available upon reasonable request.\n\nData will be provided for the purpose of secondary analyses, meta-analyses, or validation studies, subject to approval by the principal investigator and institutional review board, where applicable.', 'accessCriteria': 'Access will be granted to researchers who provide:\n\nA methodologically sound research proposal Institutional affiliation Ethical approval (if required) A signed data use agreement Requests should be directed to the principal investigator via institutional email.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poznan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}