Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2025-12-29 @ 11:59 PM
Study NCT ID:
NCT01355757
Status:
COMPLETED
Last Update Posted:
2014-05-19
First Post:
2011-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Post-Operative Quality of Life Evaluation for Different Anesthesia Techniques for Arthroscopic Shoulder Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070636', 'term': 'Rotator Cuff Injuries'}], 'ancestors': [{'id': 'D012421', 'term': 'Rupture'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}, {'id': 'D000070599', 'term': 'Shoulder Injuries'}, {'id': 'D013708', 'term': 'Tendon Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-16', 'studyFirstSubmitDate': '2011-05-16', 'studyFirstSubmitQcDate': '2011-05-17', 'lastUpdatePostDateStruct': {'date': '2014-05-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-05-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality of Life', 'timeFrame': '24 weeks', 'description': "To describe rehabilitation achievement and quality of life during 24-week follow-up after shoulder arthroscopy and rotator cuff repair, and identify any association between type of anesthesia procedure and patients' quality of life"}]}, 'conditionsModule': {'keywords': ['shoulder arthroscopy', '24-week follow-up', 'quality of life', 'rehabilitation achievement', 'rotator cuff repair'], 'conditions': ['Rotator Cuff Injury']}, 'descriptionModule': {'briefSummary': 'Randomized controlled trial on efficacy of single injection or continuous interscalene brachial plexus block on analgesia in patients having outpatient rotator cuff surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients who agree to participate in the study will be asked to sign the informed consent and the HIPAA form.\n\nInclusive criteria are:\n\n* 18-75 years of age\n* ASA physical status I-III\n* BMI \\< 35 kg/m2\n\nExclusion Criteria:\n\n* all open shoulder procedures\n* patient having difficulty understanding the instruction on using the anesthetic infusion pump\n* contraindications to administration of regional anesthesia (e.g., allergy to a local anesthetic, local infection and coagulopathy)\n* significant neurologic disorders of the upper extremity\n* psychiatric or cognitive disorders\n* history of substance abuse or chronic opioid use'}, 'identificationModule': {'nctId': 'NCT01355757', 'briefTitle': 'Post-Operative Quality of Life Evaluation for Different Anesthesia Techniques for Arthroscopic Shoulder Surgery', 'organization': {'class': 'OTHER', 'fullName': "St. Luke's-Roosevelt Hospital Center"}, 'officialTitle': 'Post-Operative Quality of Life Evaluation for Different Anesthesia Techniques for Arthroscopic Shoulder Surgery', 'orgStudyIdInfo': {'id': '10-142'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Baxter INFUSOR System', 'description': 'Regional Analgesia INFUSOR system with Patient Control Module for post-operative analgesia', 'interventionNames': ['Drug: Single Injection of Local Anesthetic']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Single Injection of Local Anesthetic', 'description': 'Single injection of 20 ml ropivacaine 0.5%', 'interventionNames': ['Device: Baxter INFUSOR System']}], 'interventions': [{'name': 'Baxter INFUSOR System', 'type': 'DEVICE', 'description': 'Regional Analgesia INFUSOR system with Patient Control Module for post-operative analgesia', 'armGroupLabels': ['Single Injection of Local Anesthetic']}, {'name': 'Single Injection of Local Anesthetic', 'type': 'DRUG', 'description': 'Single injection of 20 ml ropivacaine 0.5%', 'armGroupLabels': ['Baxter INFUSOR System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10025', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "St. Luke's-Roosevelt Hospital", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Admir Hadzic, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Luke's-Roosevelt Hospital Center"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Luke's-Roosevelt Hospital Center", 'class': 'OTHER'}, 'collaborators': [{'name': 'Baxter Healthcare Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Admir Hadzic', 'investigatorAffiliation': "St. Luke's-Roosevelt Hospital Center"}}}}