Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2026-02-20 @ 11:49 PM
Study NCT ID:
NCT02554357
Status:
COMPLETED
Last Update Posted:
2016-09-08
First Post:
2015-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Analgesia After Interscalene Block After Arthroscopic Shoulder Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000070599', 'term': 'Shoulder Injuries'}], 'ancestors': [{'id': 'D014947', 'term': 'Wounds and Injuries'}]}, '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-09', 'completionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-09-07', 'studyFirstSubmitDate': '2015-07-11', 'studyFirstSubmitQcDate': '2015-09-16', 'lastUpdatePostDateStruct': {'date': '2016-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Worst pain', 'timeFrame': 'assessed by the Modified Brief Pain Inventory short form Question 1 in the first postoperative week - postoperative day (POD) 1 through POD7'}, {'measure': 'Satisfaction with analgesia', 'timeFrame': 'assessed by the Overall Benefit of Analgesia Score (OBAS) in the first postoperative week postoperative day (POD)1 through POD7'}], 'secondaryOutcomes': [{'measure': 'Onset of sensory block', 'timeFrame': 'onset will be measured up to 30 minutes'}, {'measure': 'Duration of sensory block', 'timeFrame': 'duration will be measured up to 72 hours'}, {'measure': 'Onset of motor block', 'timeFrame': 'onset will be measured up to 30 minutes'}, {'measure': 'duration of motor block', 'timeFrame': 'duration will be measured up to 72 hours'}, {'measure': 'functionality of the surgical arm', 'timeFrame': 'assessed on the scale 0-5 in the first postoperative week - postoperative day (POD) 2- POD7'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Injury of Shoulder Region']}, 'referencesModule': {'references': [{'pmid': '28157791', 'type': 'DERIVED', 'citation': 'Vandepitte C, Kuroda M, Witvrouw R, Anne L, Bellemans J, Corten K, Vanelderen P, Mesotten D, Leunen I, Heylen M, Van Boxstael S, Golebiewski M, Van de Velde M, Knezevic NN, Hadzic A. Addition of Liposome Bupivacaine to Bupivacaine HCl Versus Bupivacaine HCl Alone for Interscalene Brachial Plexus Block in Patients Having Major Shoulder Surgery. Reg Anesth Pain Med. 2017 May/Jun;42(3):334-341. doi: 10.1097/AAP.0000000000000560.'}]}, 'descriptionModule': {'briefSummary': 'Shoulder arthroscopic causes post operative pain that outlasts analgesia provided by single injection nerve blocks.', 'detailedDescription': 'The interscalene brachial plexus block (ISBPB) is a common analgesic technique for procedures of the shoulder and upper arm.\n\nMoreover, the incidence of rebound pain is well documented and is often of considerable discomfort to patients, who may quickly go from little or no pain to moderate-severe pain. Continuous nerve block techniques with home ambulatory catheters are currently utilized to manage postoperative pain.This study is designed to compare the level and duration of pain control of Exparel® injected after bupivacaine via stop-cock connected syringes and bupivacaine alone for ISBPB.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Dutch or English speaking adults\n* 18 years or older ASA I-III physical class\n* Scheduled for elective arthroscopic shoulder surgery\n\nExclusion Criteria:\n\n* History of allergy to a local anesthetic\n* Baseline neurological deficit\n* Medical condition that would make it difficult to assess sensory distribution or communicate with the investigators' staff\n* Recent history (\\< 3 months) of drug or alcohol abuse\n* Concomitant opioid therapy\n* Preexisting coagulation disorder\n* Infection at the injection site\n* Pregnancy"}, 'identificationModule': {'nctId': 'NCT02554357', 'briefTitle': 'Quality of Analgesia After Interscalene Block After Arthroscopic Shoulder Surgery', 'organization': {'class': 'OTHER', 'fullName': 'North American Institute for Continuing Medical Education (NAICE)'}, 'officialTitle': 'Quality of Analgesia After Interscalene Block With Bupivacaine and Exparel® vs. Bupivacaine Alone After Arthroscopic Shoulder Surgery', 'orgStudyIdInfo': {'id': 'NAICE-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exparel block in arthroscopic surgery', 'description': 'Evaluation of Exparel block in arthroscopic shoulder surgery.', 'interventionNames': ['Drug: Exparel block in arthroscopic shoulder surgery']}, {'type': 'EXPERIMENTAL', 'label': 'Bupivacaine block in shoulder surgery', 'description': 'Evaluation of Bupivacaine block in shoulder surgery.', 'interventionNames': ['Drug: Bupivacaine block in shoulder surgery']}], 'interventions': [{'name': 'Exparel block in arthroscopic shoulder surgery', 'type': 'DRUG', 'otherNames': ['ISBPB with bupivacaine and Exparel'], 'description': 'The interscalene block will be performed with ultrasound guidance and nerve stimulation.', 'armGroupLabels': ['Exparel block in arthroscopic surgery']}, {'name': 'Bupivacaine block in shoulder surgery', 'type': 'DRUG', 'otherNames': ['ISBPB with bupivacaine alone'], 'description': 'The interscalene block will be performed with ultrasound guidance and nerve stimulation.', 'armGroupLabels': ['Bupivacaine block in shoulder surgery']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Genk', 'country': 'Belgium', 'facility': 'Department of Anesthesiology Ziekenhuis Oost-Limburg', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}, {'city': 'Genk', 'country': 'Belgium', 'facility': 'Department of Anesthesiology ZOL', 'geoPoint': {'lat': 50.965, 'lon': 5.50082}}], 'overallOfficials': [{'name': 'Admir Hadzic, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Director'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'North American Institute for Continuing Medical Education (NAICE)', 'class': 'OTHER'}, 'collaborators': [{'name': 'New York School of Regional Anesthesia', 'class': 'OTHER'}, {'name': 'Pacira Pharmaceuticals, Inc', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}