Ignite Creation Date:
2025-12-24 @ 2:22 PM
Ignite Modification Date:
2026-01-01 @ 6:12 PM
Study NCT ID:
NCT07263295
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-04
First Post:
2025-09-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Diaphragmatic Function After Interscalene Block With Liposomal Bupivacaine
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011885', 'term': 'Radius Fractures'}], 'ancestors': [{'id': 'D005543', 'term': 'Forearm Injuries'}, {'id': 'D001134', 'term': 'Arm Injuries'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D050723', 'term': 'Fractures, Bone'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-12-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2026-12-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-30', 'studyFirstSubmitDate': '2025-09-27', 'studyFirstSubmitQcDate': '2025-11-30', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-09-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Identification the recovery time of diaphragmatic function after diaphragmatic paralysis caused by interscalene brachial plexus block', 'timeFrame': 'From the initiation of interscalene brachial plexus block to the recovery of diaphragmatic function (within approximately 72 hours)'}], 'secondaryOutcomes': [{'measure': 'Identification the recovery time of pulmonary function after diaphragmatic paralysis', 'timeFrame': 'From the initiation of interscalene brachial plexus block to the recovery of pulmonary function (within approximately 72 hours)'}, {'measure': 'Identification the Incidence of hemidiaphragmatic paralysis at different time points', 'timeFrame': 'From the initiation of interscalene brachial plexus block to the recovery of diaphragmatic function (within approximately 72 hours)'}, {'measure': 'Identification the Proportion of pulmonary function recovery', 'timeFrame': 'Time Frame: From the initiation of interscalene brachial plexus block to the recovery of pulmonary function (within approximately 72 hours)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Interscalene brachial plexus block', 'Liposomal Bupivacaine', 'Hemidiaphragmatic paralysis'], 'conditions': ['Diaphragmatic Function', 'Metacarpal Fracture', 'Radius Fracture', 'Peripheral Nerve Neurolysis', 'Chronic Ulcer', 'Upper Extremity Ligament Injury']}, 'descriptionModule': {'briefSummary': 'The study aims to evaluation the effects of Liposomal Bupivacaine on diaphragmatic function in patients undergoing upper limb surgery who receive Interscalene Brachial Plexus Block. A total of 120 eligible patients will be enrolled and divided into two groups: Group A will receive 20ml of 0.5% Hydrochloride Bupivacaine , while Group B will receive 10ml of 0.5% Hydrochloride Bupivacaine plus 10ml of Liposomal Bupivacaine. Assessments of diaphragmatic function, pulmonary function, and pain intensity will be performed before the block and at different time points after the block, with follow-up for adverse events. The study is scheduled to run from September 2025 to September 2026, with strict adherence to privacy protection and ethical guidelines.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing upper limb surgery scheduled for interscalene brachial plexus block\n* Aged ≥ 18 years\n* American Society of Anesthesiologists (ASA) physical status I-III\n\nExclusion Criteria:\n\n* Known allergy or intolerance to amide local anesthetics\n* Nerve injury in the upper limb on the surgical side\n* Coagulopathy\n* Used opioid medications continuously for more than 3 weeks before surgery\n* History of pulmonary disease and a pulse oxygen saturation (SpO₂) \\< 95% (measured after 5 minutes of rest at room temperature without oxygen supplementation, using a transcutaneous pulse oximeter)\n* Refuse to participate or are deemed unsuitable for this trial by the researchers\n\nWithdrawal Criteria:\n\n* Patients voluntarily withdrew their informed consent\n* Surgery was canceled or the anesthesia method was changed due to surgical factors before interscalene brachial plexus block'}, 'identificationModule': {'nctId': 'NCT07263295', 'briefTitle': 'Evaluation of Diaphragmatic Function After Interscalene Block With Liposomal Bupivacaine', 'organization': {'class': 'OTHER', 'fullName': 'Zhejiang University'}, 'officialTitle': 'Evaluation of Diaphragmatic Function After Interscalene Brachial Plexus Block With Liposomal Bupivacaine: A Cohort Study', 'orgStudyIdInfo': {'id': 'ZJU_2025C116'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Group: 0.5% Hydrochloride Bupivacaine (10ml) + Liposomal Bupivacaine (10ml) for ISBPB', 'description': 'ISBPB block group receiving combined administration of two drugs', 'interventionNames': ['Drug: 0.5% Hydrochloride Bupivacaine 10ml', 'Drug: Liposomal Bupivacaine 10mL']}, {'type': 'ACTIVE_COMPARATOR', 'label': '0.5% Hydrochloride Bupivacaine (20ml) for ISBPB', 'description': 'ISBPB block control group receiving single administration of a single drug', 'interventionNames': ['Drug: 0.5% Hydrochloride Bupivacaine 20ml']}], 'interventions': [{'name': '0.5% Hydrochloride Bupivacaine 20ml', 'type': 'DRUG', 'description': '0.5% Hydrochloride Bupivacaine 20ml for ISBPB', 'armGroupLabels': ['0.5% Hydrochloride Bupivacaine (20ml) for ISBPB']}, {'name': '0.5% Hydrochloride Bupivacaine 10ml', 'type': 'DRUG', 'description': '0.5% Hydrochloride Bupivacaine 10ml for ISBPB', 'armGroupLabels': ['Experimental Group: 0.5% Hydrochloride Bupivacaine (10ml) + Liposomal Bupivacaine (10ml) for ISBPB']}, {'name': 'Liposomal Bupivacaine 10mL', 'type': 'DRUG', 'description': 'Liposomal Bupivacaine 10mL for ISBPB', 'armGroupLabels': ['Experimental Group: 0.5% Hydrochloride Bupivacaine (10ml) + Liposomal Bupivacaine (10ml) for ISBPB']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'contacts': [{'name': 'Su Diansan Diansan Su, PhD', 'role': 'CONTACT', 'email': 'diansansu@yahoo.com', 'phone': '+8618616514088', 'phoneExt': 'diansansu@yaho'}], 'facility': 'The First Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, zhejiang 310000', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Diansan Su, PhD', 'role': 'CONTACT', 'email': 'diansansu@yahoo.com', 'phone': '+8618616514088'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chair of the Department of Anesthesiology', 'investigatorFullName': 'Diansan Su', 'investigatorAffiliation': 'Zhejiang University'}}}}