Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2026-02-17 @ 11:53 PM
Study NCT ID:
NCT06789367
Status:
RECRUITING
Last Update Posted:
2025-12-11
First Post:
2025-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Dexamethasone Administration Route in PENG Block for Pediatric Hip Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006617', 'term': 'Hip Dislocation'}], 'ancestors': [{'id': 'D004204', 'term': 'Joint Dislocations'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D025981', 'term': 'Hip Injuries'}]}}, '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': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2025-01-17', 'studyFirstSubmitQcDate': '2025-01-17', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}}, '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 in milliequivalents of morphine'}, {'measure': 'NRS', 'timeFrame': '4 hours after surgery', 'description': 'The numeric rating scale (NRS) with zero meaning "no pain" and 10 meaning "the worst pain imaginable."'}, {'measure': 'NRS', 'timeFrame': '8 hours after surgery', 'description': 'The numeric rating scale (NRS) with zero meaning "no pain" and 10 meaning "the worst pain imaginable."'}, {'measure': 'NRS', 'timeFrame': '12 hours after surgery', 'description': 'The numeric rating scale (NRS) with zero meaning "no pain" and 10 meaning "the worst pain imaginable."'}, {'measure': 'NRS', 'timeFrame': '24 hours after surgery', 'description': 'The numeric rating scale (NRS) with zero meaning "no pain" and 10 meaning "the worst pain imaginable."'}, {'measure': 'NRS', 'timeFrame': '48 hours after surgery', 'description': 'The numeric rating scale (NRS) with zero meaning "no pain" and 10 meaning "the worst pain imaginable."'}, {'measure': 'Nerve damage', 'timeFrame': '12 hours after surgery', 'description': 'Nerve damage assesent will be performed using scale: N0- no nerve damage; N1- minor - sensory paresthesia; N2- majorcomplete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome'}, {'measure': 'Nerve damage', 'timeFrame': '24 hours after surgery', 'description': 'Nerve damage assesent will be performed using scale: N0- no nerve damage; N1- minor - sensory paresthesia; N2- majorcomplete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome'}, {'measure': 'Nerve damage', 'timeFrame': '48 hours after surgery', 'description': 'Nerve damage assesent will be performed using scale: N0- no nerve damage; N1- minor - sensory paresthesia; N2- majorcomplete sensory anesthesia; N3- Complete- complete motor defect with or without paraesthesia; N4-CRPS- Complex Regional Pain Syndrome'}, {'measure': 'NLR', 'timeFrame': '12 hours after surgery', 'description': 'Neutrophile-to-lymphocyte ratio'}, {'measure': 'NLR', 'timeFrame': '24 hours after surgery', 'description': 'Neutrophile-to-lymphocyte ratio'}, {'measure': 'NLR', 'timeFrame': '48 hours after surgery', 'description': 'Neutrophile-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': 'glucose', 'timeFrame': '12 hours after surgery', 'description': 'blood glucose levels'}, {'measure': 'glucose', 'timeFrame': '24 hours after surgery', 'description': 'blood glucose levels'}, {'measure': 'glucose', 'timeFrame': '48 hours after surgery', 'description': 'blood glucose levels'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pericapsular nerve group block', 'PENG block', 'dexamethasone', 'adjuvant'], 'conditions': ['Hip Dysplasia', 'Hip Disease']}, 'descriptionModule': {'briefSummary': 'This study aims to assess the impact of the administration route of dexamethasone (intravenous vs. perineural) on postoperative pain, inflammatory response, and neuromonitoring parameters in pediatric patients undergoing hip surgery. The primary outcome is postoperative pain intensity measured using an age-appropriate pain scale at multiple time intervals. Secondary outcomes include inflammatory markers such as neutrophil-to-lymphocyte ratio (NLR) and platelet-to-lymphocyte ratio (PLR), opioid consumption, time to first rescue analgesia, and overall patient recovery. This randomized, double-blinded study seeks to improve pain management strategies and optimize anesthesia protocols in pediatric hip surgery.', 'detailedDescription': 'Pediatric hip surgery is a complex procedure that can result in significant postoperative pain and an inflammatory response. Effective pain management is critical in this population to promote early mobilization, reduce opioid consumption, and minimize adverse outcomes. The pericapsular nerve group (PENG) block is a regional anesthesia technique that offers targeted analgesia for hip procedures while preserving motor function, making it particularly suitable for pediatric patients.\n\nDexamethasone is commonly used as an adjuvant in regional anesthesia to prolong analgesia and mitigate inflammation. However, the optimal administration route of dexamethasone in the context of PENG block for pediatric hip surgery remains unclear. This study is designed to compare the efficacy of intravenous versus perineural dexamethasone in prolonging postoperative analgesia and reducing inflammatory responses.\n\nThis prospective, randomized, double-blinded clinical trial will enroll pediatric patients undergoing elective hip surgery. Participants will be randomized into two groups: one group will receive intravenous dexamethasone, while the other will receive perineural dexamethasone administered as part of the PENG block. All patients will receive standardized general anesthesia and PENG block using a local anesthetic at a fixed concentration.\n\nThe primary outcome will be time to first request rescue analgesia. Secondary outcomes include the inflammatory response measured by NLR and PLR, postoperative pain intensity, assessed using an age-appropriate pain scale at predefined time intervals, total opioid consumption, and blood glucose levels. The study will also monitor neuromonitoring parameters during surgery to ensure patient safety and evaluate the influence of dexamethasone on neurological outcomes.\n\nSafety will be closely monitored throughout the study, with particular attention to potential complications such as local anesthetic systemic toxicity (LAST) or dexamethasone-related adverse events.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '6 Years', 'minimumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children scheduled for hip surgery\n* body weight \\> 5kg\n\nExclusion Criteria:\n\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': 'NCT06789367', 'briefTitle': 'The Effect of Dexamethasone Administration Route in PENG Block for Pediatric Hip Surgery', '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 Pediatric Hip Surgery', 'orgStudyIdInfo': {'id': '3/2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'perinerual 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 0.5ml/kg 0.2% ropivacaine + 0,1mgkg perineural Dexamethasone', 'armGroupLabels': ['perinerual dexamethasone']}, {'name': 'intravenous Dexamethsone 4mg', 'type': 'DRUG', 'description': 'PENG block with 0,5ml/kg 0.2% ropivacaine + 0,1mg/kg intravenous Dexamethasone', 'armGroupLabels': ['intravenous dexamethasone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60-701', 'city': 'Poznan', 'status': 'RECRUITING', 'country': 'Poland', 'contacts': [{'name': 'Malgorzata Reysner, M.D. Ph.D.', 'role': 'CONTACT', 'email': 'mdomagalska@ump.edu.pl', 'phone': '+48 608762068'}], 'facility': 'Poznan University of Medical Sciences', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}], 'centralContacts': [{'name': 'Malgorztat Reysner, M.D. Ph.D.', 'role': 'CONTACT', 'email': 'mdomagalska@ump.edu.pl', 'phone': '+48 608762068'}], 'overallOfficials': [{'name': 'Malgorzata Reysner, M.D. Ph.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Poznań University of Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poznan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}