Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2025-12-25 @ 11:17 PM
Study NCT ID:
NCT05868993
Status:
RECRUITING
Last Update Posted:
2023-05-22
First Post:
2023-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Optimal Effective Local Anesthetic Volume for Pain Relief Using Brachial Plexus Block
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}], '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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-02-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-05-11', 'studyFirstSubmitDate': '2023-04-27', 'studyFirstSubmitQcDate': '2023-05-11', 'lastUpdatePostDateStruct': {'date': '2023-05-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Block Success', 'timeFrame': '60min after surgery', 'description': 'Block success measured by pain (11-point VAS)'}, {'measure': 'Lung Function', 'timeFrame': '60 mins after surgery', 'description': 'Block success as measured by preservation of lung function (Vital Capacity in L)'}, {'measure': 'Block Success', 'timeFrame': '60 mins after surgery', 'description': 'Block Success measured by opioid (mcg of fentanyl delivered)'}], 'secondaryOutcomes': [{'measure': 'Diaphragm Excursion', 'timeFrame': '60 minutes after surgery', 'description': 'Change in Movement of Diaphragm in cm'}, {'measure': 'Vital Capacity', 'timeFrame': '60 minutes after surgery', 'description': 'Change in Vital Capacity measured in L'}, {'measure': 'Pulse Oximetry', 'timeFrame': '60 minutes after surgery', 'description': 'Change in Pulse Oximetry Value'}, {'measure': 'Side Effects', 'timeFrame': '60 minutes after surgery', 'description': "Rate of Dyspnea, Horner's, Hoarseness"}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['brachial plexus block'], 'conditions': ['Post Operative Pain']}, 'descriptionModule': {'briefSummary': 'Prospective, patient-blinded study utilizing a novel Continuous Reassessment Method that concomitantly considers both block success and block side effects (lung dysfunction) for brachial plexus nerve blocks.', 'detailedDescription': 'Success or failure of the brachial plexus block for any given volume will be determined by the verbal analogue pain scale score obtained 60 minutes after surgical end time. Volumes will be determined by continuous reassessment method.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Surgical candidate for Arthroscopic rotator cuff surgery\n* ASA I-III\n* BMI\\<40\n* Age \\>18\n\nExclusion Criteria:\n\n* Inability to give informed consent\n* Inability to complete consent process in English\n* allergy to ropivacaine\n* neuropathy\n* contraindications to peripheral nerve block per ASRA guidelines\n* chronic opioid use\n* infection at the injection/catheter site\n* limb restriction due to medical history\n* history of moderate - severe lung disease.'}, 'identificationModule': {'nctId': 'NCT05868993', 'briefTitle': 'Optimal Effective Local Anesthetic Volume for Pain Relief Using Brachial Plexus Block', 'organization': {'class': 'OTHER', 'fullName': 'Benaroya Research Institute'}, 'officialTitle': 'Optimal Effective Local Anesthetic Volume for Pain Relief Using Brachial Plexus Block Utilizing Continuous Reassessment Method for Arthroscopic Rotator Cuff Shoulder Surgery', 'orgStudyIdInfo': {'id': 'IRB20-018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brachial Plexus Block Group 1', 'description': 'Interscalene', 'interventionNames': ['Drug: Dose of 0.5% Ropivacaine']}, {'type': 'EXPERIMENTAL', 'label': 'Brachial Plexus Group 2', 'description': 'Supraclavicular', 'interventionNames': ['Drug: Dose of 0.5% Ropivacaine']}, {'type': 'EXPERIMENTAL', 'label': 'Brachial Plexus Group 3', 'description': 'Suprascapular', 'interventionNames': ['Drug: Dose of 0.5% Ropivacaine']}], 'interventions': [{'name': 'Dose of 0.5% Ropivacaine', 'type': 'DRUG', 'description': 'Dose varied by 5mL of 0.5% Ropivacaine', 'armGroupLabels': ['Brachial Plexus Block Group 1', 'Brachial Plexus Group 2', 'Brachial Plexus Group 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '98101', 'city': 'Seattle', 'state': 'Washington', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'David B Auyong, MD', 'role': 'CONTACT', 'email': 'David.Auyong@virginiamason.org', 'phone': '206-223-6980'}, {'name': 'David B Auyong, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Virginia Mason Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'centralContacts': [{'name': 'David Auyong', 'role': 'CONTACT', 'email': 'anedba@vmmc.org', 'phone': '206-223-6980'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benaroya Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}