Ignite Creation Date:
2025-12-24 @ 3:16 PM
Ignite Modification Date:
2025-12-25 @ 10:57 PM
Study NCT ID:
NCT06086392
Status:
COMPLETED
Last Update Posted:
2025-07-23
First Post:
2023-10-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Perineural Dexamethasone in Supraclavicular Brachial Plexus Block for Anesthesia After Pediatric Hand/Wrist Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006230', 'term': 'Hand Injuries'}, {'id': 'D014954', 'term': 'Wrist Injuries'}, {'id': 'D004194', 'term': 'Disease'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': '2024-01', 'completionDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-19', 'studyFirstSubmitDate': '2023-10-11', 'studyFirstSubmitQcDate': '2023-10-11', 'lastUpdatePostDateStruct': {'date': '2025-07-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', '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 hour 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': 'Finger movement every 4 hours'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Wrist Disease', 'Hand Injuries', 'Wrist Injuries', 'Hand Disease', 'Hand Injuries and Disorders']}, 'descriptionModule': {'briefSummary': 'Effect of Perineural Dexamethasone on the Duration of Supraclavicular Brachial Plexus Block for Anesthesia After Pediatric Hand/Wrist Surgery', 'detailedDescription': "This study is proposed to explore the effect of perineurial Dexamethasone on the duration of supraclavicular brachial plexus block for analgesia after pediatric ankle surgery.\n\nAfter hand and wrist 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': 'NCT06086392', 'briefTitle': 'Perineural Dexamethasone in Supraclavicular Brachial Plexus Block for Anesthesia After Pediatric Hand/Wrist Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Poznan University of Medical Sciences'}, 'officialTitle': 'Effect of Perineural Dexamethasone on the Duration of Supraclavicular Brachial Plexus Block for Anesthesia After Pediatric Hand/Wrist Surgery', 'orgStudyIdInfo': {'id': '12/2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo', 'description': '0.2% ropivacaine for supraclavicular brachial plexus block', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': '0.1mg/kg Dexamethasone', 'description': '0,1mg/kg dexamethasone added to 0.2% ropivacaine for supraclavicular brachial plexus 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 supraclavicular brachial plexus block', 'interventionNames': ['Drug: 0.05mg/kg Dexamethasone']}], 'interventions': [{'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['0.9% sodium chloride'], 'description': 'administration of 0.5ml/kg of 0,2% ropivacaine + 0.01ml/kg 0.9% sodium chloride for the supraclavicular brachial plexus block', 'armGroupLabels': ['Placebo']}, {'name': '0.1mg/kg Dexamethasone', 'type': 'DRUG', 'otherNames': ['large dose dexamethasone'], 'description': 'administration of 0.5ml/kg of 0.2% ropivacaine with 0.1mg/kg Dexamethasone for the supraclavicular brachial plexus block', 'armGroupLabels': ['0.1mg/kg Dexamethasone']}, {'name': '0.05mg/kg Dexamethasone', 'type': 'DRUG', 'otherNames': ['small dose dexamethasone'], 'description': 'administration of 0.5ml/kg of 0,2% ropivacaine with 0.05mg/kg Dexamethasone for the supraclavicular brachial plexus block', 'armGroupLabels': ['0,05mg/kg dexamethasone']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61-701', 'city': 'Skórzewo', 'state': 'Poznań', 'country': 'Poland', 'facility': 'Poznan University of Medical Sciences', 'geoPoint': {'lat': 53.03629, 'lon': 17.81889}}], 'overallOfficials': [{'name': 'Leszek Romanowski, 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'}}}}