Ignite Creation Date:
2025-12-24 @ 3:15 PM
Ignite Modification Date:
2025-12-25 @ 11:51 PM
Study NCT ID:
NCT03785392
Status:
TERMINATED
Last Update Posted:
2020-12-03
First Post:
2018-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Out of Plane Approach for Interscalene
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'whyStopped': 'Primary investigator left the Institution', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2019-12-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-01', 'studyFirstSubmitDate': '2018-11-07', 'studyFirstSubmitQcDate': '2018-12-21', 'lastUpdatePostDateStruct': {'date': '2020-12-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Forced Expiratory Volume (FEV1)', 'timeFrame': 'The change in Forced Expiratory Volume in one second (FEV1) from Baseline to 15 minutes', 'description': 'Forced Expiratory Volume in one second (FEV1) is measured in liters.'}], 'secondaryOutcomes': [{'measure': 'Forced Vital Capacity (FVC)', 'timeFrame': 'The change in Forced Vital Capacity (FVC) from Baseline to 15 minutes', 'description': 'Forced Vital Capacity (FVC) is measured in liters.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Acute Pain', 'Brachial Plexus Block']}, 'descriptionModule': {'briefSummary': 'Study aims to examine the influence of out of plane interscalene approach to a brachial plexus block on the effect of phrenic nerve blockade.', 'detailedDescription': 'Studies have proven that there is 100% blockade of the phrenic nerve with the in-plane approach to the interscalene brachial plexus block. The patient population with pulmonary comorbidities with poor reserve cannot afford to have a further deterioration of their pulmonary status due to phrenic nerve blockade. These patients are not ideal candidates for increased opiate therapy for intraoperative and post-surgical pain as well due to further depression of their respiratory function. To optimize their pain control as well as avoid any respiratory-related morbidity and mortality, it is ideal to develop a technique which can provide appropriate brachial plexus block at the interscalene level while completely avoiding any local anesthetic spread to the phrenic nerve.\n\nThe study aims to examine the influence of out of plane interscalene approach to a brachial plexus block on the effect of phrenic nerve blockade. Practitioner preference and institutional norms often influence the in plane approach for the above-mentioned block. The most common practice at our institution is the in plane approach to the brachial plexus block.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients(18-85 years old)\n* Scheduled for elective shoulder surgery who would benefit from a preoperative interscalene approach to the brachial plexus block for intraoperative and postoperative pain relief.\n\nExclusion Criteria:\n\n* Patients with any distorted anatomy for whom the block cannot be performed accurately, such as scars, surgical fixtures at the site, active infection, any open wound or drains at the site.\n* Patients who request benzodiazepine anxiolytics such as midazolam for premedication before the procedure. Also patients who request narcotic medications as premedication before the procedure\n* Non-English and Non-Spanish speaking patients\n* Inadequate or failed blocks and inadvertently intrathecal or intravascular injection will be dropped from the study\n* Incarcerated patients\n* Expected heavy bleeding on multiple anticoagulants with markedly elevated PT ( Prothrombin time ), INR (International Normalized Ratio ), PTT ( Partial Thromboplastin Time ) levels and markedly reduced platelet counts'}, 'identificationModule': {'nctId': 'NCT03785392', 'briefTitle': 'Out of Plane Approach for Interscalene', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Medical Branch, Galveston'}, 'officialTitle': 'Out of Plane Approach for Interscalene Level Brachial Plexus Block to Avoid Phrenic Nerve Involvement - a Prospective Study', 'orgStudyIdInfo': {'id': '17-0121'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group 1 Inplane', 'description': 'Study with the technique Inplane group', 'interventionNames': ['Procedure: Group 1 In-plane']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2 out of plane', 'description': 'Study with the technique out of plane', 'interventionNames': ['Procedure: Group 2 out of plane']}], 'interventions': [{'name': 'Group 1 In-plane', 'type': 'PROCEDURE', 'description': 'Group 1: Study will involve total of 15 patients with the procedure done in-plane. Before the block placement and after the block placement lung function will be measured.\n\nFEV1 (forced expiratory volume in 1 second ) and FVC ( forced vital Capacity ) values will be recorded. Block will be performed in plane and postprocedure lung function test will be repeated. New values of FEV1 and FVC will be obtained after the placement of the nerve block.', 'armGroupLabels': ['Group 1 Inplane']}, {'name': 'Group 2 out of plane', 'type': 'PROCEDURE', 'description': 'Group 2 study will adopt the out of plane technique and will involve a total of 15 patients in this group. We will do the procedure out of plane and will have lung function FEV1 and FVC measured bedside.FEV1 and FVC values will be recorded. Block will be performed out of plane and postprocedure lung function test will be measured. New values of FEV1 and FVC will be obtained', 'armGroupLabels': ['Group 2 out of plane']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77555', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'UTMB', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}, {'zip': '77573', 'city': 'League City', 'state': 'Texas', 'country': 'United States', 'facility': 'UTMB', 'geoPoint': {'lat': 29.50745, 'lon': -95.09493}}], 'overallOfficials': [{'name': 'Ranganathan Govindaraj, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UTMB'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Medical Branch, Galveston', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}