Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-26 @ 3:51 AM
Study NCT ID:
NCT06086418
Status:
COMPLETED
Last Update Posted:
2025-01-21
First Post:
2023-10-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Perineural Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Pediatric Ankle Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016512', 'term': 'Ankle Injuries'}, {'id': 'D018409', 'term': 'Foot Injuries'}, {'id': 'D005534', 'term': 'Foot Diseases'}], 'ancestors': [{'id': 'D007869', 'term': 'Leg Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012965', 'term': 'Sodium Chloride'}, {'id': 'D003907', 'term': 'Dexamethasone'}], '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': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-17', 'studyFirstSubmitDate': '2023-10-11', 'studyFirstSubmitQcDate': '2023-10-11', 'lastUpdatePostDateStruct': {'date': '2025-01-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'first need of opiate', 'timeFrame': '48 hours', 'description': 'Time after surgery when the patient needs opiate for the first time'}], 'secondaryOutcomes': [{'measure': 'Opioid Consumption', 'timeFrame': '48 hours', 'description': 'Total opiate consumption after surgery'}, {'measure': 'Pain score', 'timeFrame': '4 hours, 8 hours, 12 hours, 16 hours, 18 hours, 24 hours, 28 hours, 32 hours, 36 hours, 40 hours, 44 hours, 48 hours after surgery', 'description': 'children \\<3years old FLACC score (Face, Legs, Activity, Cry, Consolability) children \\>3years old NRS (Numerical Rating Scale)'}, {'measure': 'Blood glucose', 'timeFrame': '24 and 48 hours after surgery', 'description': 'Blood glucose every 24 hours during hospitalization'}, {'measure': 'NLR', 'timeFrame': '24 and 48 hours after surgery', 'description': 'Neutrophil-to-lymphocyte ratio'}, {'measure': 'PLR', 'timeFrame': '24 and 48 hours after surgery', 'description': 'Platelet-to-lymphocyte ratio'}, {'measure': 'Mobilisation', 'timeFrame': '4 hours, 8 hours, 12 hours, 16 hours, 18 hours, 24 hours, 28 hours, 32 hours, 36 hours, 40 hours, 44 hours, 48 hours after surgery', 'description': 'Toe movement every 4 hours'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Ankle Disease', 'Ankle Injuries', 'Foot Injury', 'Foot Diseases']}, 'referencesModule': {'references': [{'pmid': '39209730', 'type': 'DERIVED', 'citation': 'Reysner M, Reysner T, Janusz P, Kowalski G, Shadi M, Daroszewski P, Wieczorowska-Tobis K, Kotwicki T. Dexamethasone as a perineural adjuvant to a ropivacaine popliteal sciatic nerve block for pediatric foot surgery: a randomized, double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2024 Aug 29:rapm-2024-105694. doi: 10.1136/rapm-2024-105694. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'Effect of Perineural Dexamethasone on the duration of popliteal nerve block for Anesthesia After Pediatric ankle/foot surgery.', 'detailedDescription': "This study is proposed to explore the effect of systemic Dexamethasone on the duration of supraclavicular brachial plexus block for analgesia after pediatric ankle surgery.\n\nAfter foot and ankle surgery, children need good analgesia. Peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe.\n\nThe safety of local anesthesia is essential in children due to the much lower toxicity threshold of local anesthetics. An effective adjuvant, such as Dexamethasone, could allow for a higher dilution of local anesthetics while maintaining and enhancing their analgesic effect.\n\nThere is considerable research where intravenous and perineural dexamethasone use has been compared in adults. However, there is a massive lack of research regarding children.\n\nIn this study, investigators compare different doses of perineural Dexamethasone. Groups 2 and 3 have dexamethasone doses of 0.1mg/kg and 0.05mg/kg added to local anesthetic.\n\nThe investigator's goal is to find a dexamethasone dose that is as low as possible but simultaneously covers the need for good pain relief and fast recovery postoperatively."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '3 Months', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* children scheduled for hand/wrist surgery\n* body weight \\> 5kg\n\nExclusion Criteria:\n\n* infection at the site of the regional blockade\n* coagulation disorders\n* immunodeficiency\n* ASA= or \\>4\n* steroid medication in regular use'}, 'identificationModule': {'nctId': 'NCT06086418', 'briefTitle': 'Perineural Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Pediatric Ankle Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Poznan University of Medical Sciences'}, 'officialTitle': 'Effect of Perineural Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Pediatric Ankle Surgery', 'orgStudyIdInfo': {'id': '13/2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': '0.2% ropivacaine for popliteal nerve block', 'interventionNames': ['Drug: 0.9 % Sodium Chloride']}, {'type': 'ACTIVE_COMPARATOR', 'label': '0.1mg/kg Dexamethasone', 'description': '0.1mg/kg dexamethasone added to 0.2% ropivacaine for popliteal nerve block', 'interventionNames': ['Drug: 0.1mg/kg Dexamethasone']}, {'type': 'ACTIVE_COMPARATOR', 'label': '0,05mg/kg dexamethasone', 'description': '0.05mg/kg dexamethasone added to 0.2% ropivacaine for popliteal nerve block', 'interventionNames': ['Drug: 0.05mg/kg Dexamethasone']}], 'interventions': [{'name': '0.9 % Sodium Chloride', 'type': 'DRUG', 'otherNames': ['placebo'], 'description': 'administration of 0.5ml/kg of 0,2% ropivacaine + 0.01ml/kg 0.9% sodium chloride for the popliteal nerve block', 'armGroupLabels': ['placebo']}, {'name': '0.1mg/kg Dexamethasone', 'type': 'DRUG', 'otherNames': ['large dose'], 'description': 'administration of 0.5ml/kg of 0.2% ropivacaine with 0.1mg/kg Dexamethasone for the popliteal nerve block', 'armGroupLabels': ['0.1mg/kg Dexamethasone']}, {'name': '0.05mg/kg Dexamethasone', 'type': 'DRUG', 'otherNames': ['small dose'], 'description': 'administration of 0.5ml/kg of 0.2% ropivacaine with 0.05mg/kg Dexamethasone for the popliteal nerve block', 'armGroupLabels': ['0,05mg/kg dexamethasone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61-701', 'city': 'Poznan', 'state': 'Poznań', 'country': 'Poland', 'facility': 'Poznan University of Medical Sciences', 'geoPoint': {'lat': 52.40692, 'lon': 16.92993}}], 'overallOfficials': [{'name': 'Tomasz Kotwicki, Prof.dr hab.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Poznan University of Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poznan University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}