Ignite Creation Date:
2025-12-26 @ 10:32 AM
Ignite Modification Date:
2026-01-13 @ 1:03 PM
Study NCT ID:
NCT06789328
Status:
COMPLETED
Last Update Posted:
2025-07-23
First Post:
2025-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Dexamethasone Administration Route on Pain and Inflammatory Response in PENG Block for Total Hip Arthroplasty
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-19', 'studyFirstSubmitDate': '2025-01-17', 'studyFirstSubmitQcDate': '2025-01-17', 'lastUpdatePostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to first rescue opioid analgesia', 'timeFrame': '48 hours after surgery', 'description': 'Time to first rescue opioid analgesia'}], 'secondaryOutcomes': [{'measure': 'Total opioid consumption', 'timeFrame': '48 hours after surgery', 'description': 'Total opioid consumption (mg) converted to morphine milligram equivalents (MME)'}, {'measure': 'NRS', 'timeFrame': '4 hours after surgery', 'description': 'Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")'}, {'measure': 'NRS', 'timeFrame': '8 hours after surgery', 'description': 'Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")'}, {'measure': 'NRS', 'timeFrame': '12 hours after surgery', 'description': 'Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")'}, {'measure': 'NRS', 'timeFrame': '24 hours after surgery', 'description': 'Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")'}, {'measure': 'NRS', 'timeFrame': '48 hours after surgery', 'description': 'Numeric Rating Scale (NRS), ranging from 0 ("no pain") to 10 ("the worst pain imaginable")'}, {'measure': 'NLR', 'timeFrame': '12 hours after surgery', 'description': 'Neutrophil-to-lymphocyte ratio'}, {'measure': 'NLR', 'timeFrame': '24 hours after surgery', 'description': 'Neutrophil-to-lymphocyte ratio'}, {'measure': 'NLR', 'timeFrame': '48 hours after surgery', 'description': 'Neutrophil-to-lymphocyte ratio'}, {'measure': 'PLR', 'timeFrame': '12 hours after surgery', 'description': 'Platelet-to-lymphocyte ratio'}, {'measure': 'PLR', 'timeFrame': '24 hours after surgery', 'description': 'Platelet-to-lymphocyte ratio'}, {'measure': 'PLR', 'timeFrame': '48 hours after surgery', 'description': 'Platelet-to-lymphocyte ratio'}, {'measure': 'Quadriceps muscle strength assessed using medical research council scale [range 0:5]', 'timeFrame': '4 hours after surgery', 'description': 'uadriceps muscle strength, including knee extension and hip adduction, will be evaluated using the Medical Research Council (MRC) muscle strength grading scale.'}, {'measure': 'Quadriceps muscle strength assessed using medical research council scale [range 0:5]', 'timeFrame': '8 hours after surgery', 'description': 'uadriceps muscle strength, including knee extension and hip adduction, will be evaluated using the Medical Research Council (MRC) muscle strength grading scale.'}, {'measure': 'Quadriceps muscle strength assessed using medical research council scale [range 0:5]', 'timeFrame': '12 hours after surgery', 'description': 'uadriceps muscle strength, including knee extension and hip adduction, will be evaluated using the Medical Research Council (MRC) muscle strength grading scale.'}, {'measure': 'Quadriceps muscle strength assessed using medical research council scale [range 0:5]', 'timeFrame': '24 hours after surgery', 'description': 'uadriceps muscle strength, including knee extension and hip adduction, will be evaluated using the Medical Research Council (MRC) muscle strength grading scale.'}, {'measure': 'Quadriceps muscle strength assessed using medical research council scale [range 0:5]', 'timeFrame': '48 hours after surgery', 'description': 'uadriceps muscle strength, including knee extension and hip adduction, will be evaluated using the Medical Research Council (MRC) muscle strength grading scale.'}, {'measure': 'Nerve damage', 'timeFrame': '12 hours after surgery', 'description': 'Nerve damage assessment will be performed using the following grading scale:\n\nN0 - No nerve damage N1 - Minor: sensory paresthesia N2 - Major: complete sensory anesthesia N3 - Complete: complete motor deficit with or without paresthesia N4 - CRPS: Complex Regional Pain Syndrome'}, {'measure': 'Nerve damage', 'timeFrame': '24 hours after surgery', 'description': 'Nerve damage assessment will be performed using the following grading scale:\n\nN0 - No nerve damage N1 - Minor: sensory paresthesia N2 - Major: complete sensory anesthesia N3 - Complete: complete motor deficit with or without paresthesia N4 - CRPS: Complex Regional Pain Syndrome'}, {'measure': 'Nerve damage', 'timeFrame': '48 hours after surgery', 'description': 'Nerve damage assessment will be performed using the following grading scale:\n\nN0 - No nerve damage N1 - Minor: sensory paresthesia N2 - Major: complete sensory anesthesia N3 - Complete: complete motor deficit with or without paresthesia N4 - CRPS: Complex Regional Pain Syndrome'}, {'measure': 'glucose', 'timeFrame': '12 hours after surgery', 'description': 'blood glucose level'}, {'measure': 'glucose', 'timeFrame': '24 hours after surgery', 'description': 'blood glucose level'}, {'measure': 'glucose', 'timeFrame': '48 hours after surgery', 'description': 'blood glucose level'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pericapsular nerve group block', 'PENG block', 'adjuvant', 'dexamethasone'], 'conditions': ['Osteoarthritis, Hip', 'Hip Pain Chronic', 'Hip Arthropathy', 'Hip Arthritis']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effect of the dexamethasone administration route (intravenous vs. perineural) on postoperative pain, inflammatory response, and clinical outcomes in patients undergoing total hip arthroplasty (THA) with a pericapsular nerve group (PENG) block. The primary outcome is the intensity of postoperative pain measured using the numerical rating scale (NRS) at rest and during movement. Secondary outcomes include the inflammatory response assessed by neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR), opioid consumption, and patient satisfaction. The findings from this study may contribute to optimizing anesthesia protocols and improving postoperative recovery in patients undergoing THA.', 'detailedDescription': 'Total hip arthroplasty (THA) is a common orthopedic procedure associated with significant postoperative pain and inflammation, which can impact recovery and long-term outcomes. Regional anesthesia techniques, such as the pericapsular nerve group (PENG) block, have become increasingly popular for pain management in THA due to their ability to provide effective analgesia while preserving motor function.\n\nDexamethasone is frequently used as an adjuvant in regional anesthesia to prolong the duration of analgesia and reduce inflammation. However, there is limited evidence comparing the efficacy of different administration routes of dexamethasone (intravenous vs. perineural) in the context of PENG block. Additionally, understanding the impact of dexamethasone on postoperative pain, inflammatory markers, and overall patient recovery is crucial for optimizing clinical protocols.\n\nThis study is a prospective, randomized, double-blinded trial involving patients undergoing elective THA. Participants will be randomly assigned to two groups: the IV dexamethasone group or the perineural dexamethasone group. Both groups will receive standardized general anesthesia and PENG block with local anesthetic. Postoperative pain will be assessed using the NRS at various time intervals (e.g., 6, 12, 24, and 48 hours postoperatively) at rest and during movement. NLR and PLR will measure the inflammatory response from blood samples taken preoperatively and 24 hours postoperatively.\n\nThe primary outcome is time first to request rescue analgesia. Secondary outcomes include cumulative opioid consumption, length of hospital stay, and patient satisfaction. Safety and potential complications, such as local anesthetic systemic toxicity (LAST), will be closely monitored.\n\nThe results of this study may provide valuable insights into the optimal use of dexamethasone as an adjuvant in regional anesthesia for THA, potentially improving pain management, reducing opioid use, and enhancing postoperative recovery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients scheduled for total hip arthroplasty\n* patients aged \\>65 and \\<100 years\n* patients able to provide informed consent\n* patients able to reliably report symptoms to the research team\n\nExclusion Criteria:\n\n* inability to provide first-party consent due to cognitive impairment or a language barrier\n* infection at the site of the regional block,\n* coagulation disorders,\n* immunodeficiency,\n* American Society of Anesthesiologists (ASA) physical status of IV or higher,\n* history of regular steroid medication.'}, 'identificationModule': {'nctId': 'NCT06789328', 'briefTitle': 'The Effect of Dexamethasone Administration Route on Pain and Inflammatory Response in PENG Block for Total Hip Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Poznan University of Medical Sciences'}, 'officialTitle': 'The Effect of Dexamethasone Administration Route on Pain and Inflammatory Response in PENG Block for Total Hip Arthroplasty', 'orgStudyIdInfo': {'id': '2/2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Perineural dexamethasone', 'description': 'PENG block + perineural dexamethasone', 'interventionNames': ['Drug: perineural Dexamethasone 4mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Intravenous dexamethasone', 'description': 'PENG block + intravenous dexamethasone', 'interventionNames': ['Drug: intravenous Dexamethsone 4mg']}], 'interventions': [{'name': 'perineural Dexamethasone 4mg', 'type': 'DRUG', 'description': 'PENG block with 20ml 0.2% ropivacaine + 4mg perineural Dexamethasone', 'armGroupLabels': ['Perineural dexamethasone']}, {'name': 'intravenous Dexamethsone 4mg', 'type': 'DRUG', 'description': 'PENG block with 20ml 0.2% ropivacaine + 4mg intravenous Dexamethasone', 'armGroupLabels': ['Intravenous dexamethasone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60-701', 'city': 'Poznan', 'country': 'Poland', 'facility': 'Poznan University of Medical Sciences', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}], 'overallOfficials': [{'name': 'Malgorzata Reysner, M.D. Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Poznań University of Medical Sciences'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poznan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}