Ignite Creation Date:
2025-12-24 @ 11:34 PM
Ignite Modification Date:
2026-02-25 @ 8:17 PM
Study NCT ID:
NCT02756156
Status:
UNKNOWN
Last Update Posted:
2016-04-29
First Post:
2016-03-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Low Dose Interscalene and Infraclavicular Block for Humerus Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006810', 'term': 'Humeral Fractures'}], 'ancestors': [{'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-03', 'completionDateStruct': {'date': '2016-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-04-26', 'studyFirstSubmitDate': '2016-03-15', 'studyFirstSubmitQcDate': '2016-04-26', 'lastUpdatePostDateStruct': {'date': '2016-04-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success rate of block', 'timeFrame': '10 min.- 20 min.', 'description': 'A complete sensory loss in distribution of the radial, median, ulnar, musculocutaneous and medial cutaneous nerves of the arm'}], 'secondaryOutcomes': [{'measure': 'Technique duration', 'timeFrame': '5 min.'}, {'measure': 'Number of participants with treatment-related adverse events as assessed by CTCAE v4.0', 'timeFrame': '24 hours'}, {'measure': 'Complication rate', 'timeFrame': '24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['interscalene', 'infraclavicular', 'humerus surgery'], 'conditions': ['Humerus Fracture']}, 'descriptionModule': {'briefSummary': 'Combining interscalene block with infraclavicular block for humerus surgery provides a unique surgical anaesthesia and postoperative analgesia.', 'detailedDescription': 'Interscalene block provides effective surgical anaesthesia for shoulder and proximal arm surgery. However, sometimes it can be inadequate for distal arm surgery. Combining infraclavicular block with interscalene block may provide a successful surgical anaesthesia for humerus surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing humerus surgery.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients accepting peripheral nerve block technique for humerus surgery\n* Unilateral orthopedic humerus surgery\n* 18 years of age or older\n\nExclusion Criteria:\n\n* Patients refused peripheral nerve block\n* Non-cooperate patients\n* Neuropathy of any etiology in the affected extremity'}, 'identificationModule': {'nctId': 'NCT02756156', 'briefTitle': 'Low Dose Interscalene and Infraclavicular Block for Humerus Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Kahramanmaras Sutcu Imam University'}, 'officialTitle': 'Low Dose Interscalene and Infraclavicular Block for Humerus Surgery', 'orgStudyIdInfo': {'id': '76263'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Bora Bilal, Asist. Prof.', 'role': 'CONTACT', 'email': 'bilalbora@yahoo.com', 'phone': '+903442803245'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kahramanmaras Sutcu Imam University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assist prof', 'investigatorFullName': 'Bora Bilal', 'investigatorAffiliation': 'Kahramanmaras Sutcu Imam University'}}}}