Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 11:21 PM
Study NCT ID:
NCT01126593
Status:
COMPLETED
Last Update Posted:
2014-11-07
First Post:
2010-05-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Post-Op Rotator Cuff Pain Study With Subacromial Bupivacaine Infusion
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002045', 'term': 'Bupivacaine'}, {'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'orlandosportsdoc@yahoo.com', 'phone': '(407) 254-2500', 'title': 'Dr. Randy Schwartzberg', 'organization': 'Orlando Orthopaedic Center'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'It is possible that different catheter infusion rates, different bupivacaine concentrations, and pain modulation agents different from bupivacaine could result in different findings.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were assesed for 6 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo Group', 'description': 'The placebo group will receive the same subacromial infusion catheter as the study group.However, the reservoir will be filled with 200cc of 0.9% normal saline.', 'otherNumAtRisk': 33, 'otherNumAffected': 0, 'seriousNumAtRisk': 33, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Group', 'description': 'The control group patients will receive no continuous infusion catheter.', 'otherNumAtRisk': 29, 'otherNumAffected': 0, 'seriousNumAtRisk': 29, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Study Group', 'description': 'Study group patients will receive a subacromial continuous standard spring loaded infusion catheter with 200cc of 0.5% bupivacaine in its reservoir. The infusion rate will be 4cc per hour.', 'otherNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}, {'value': '32', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Group', 'description': 'The placebo group will receive the same subacromial infusion catheter as the study group.However, the reservoir will be filled with 200cc of 0.9% normal saline.'}, {'id': 'OG001', 'title': 'Control Group', 'description': 'The control group patients will receive no continuous infusion catheter.'}, {'id': 'OG002', 'title': 'Study Group', 'description': 'Study group patients will receive a subacromial continuous standard spring loaded infusion catheter with 200cc of 0.5% bupivacaine in its reservoir. The infusion rate will be 4cc per hour.'}], 'classes': [{'title': 'Pain at baseline', 'categories': [{'measurements': [{'value': '64.7', 'spread': '25.9', 'groupId': 'OG000'}, {'value': '43.9', 'spread': '33.6', 'groupId': 'OG001'}, {'value': '51.4', 'spread': '31.1', 'groupId': 'OG002'}]}]}, {'title': 'Pain at 1 hour', 'categories': [{'measurements': [{'value': '60', 'spread': '19.5', 'groupId': 'OG000'}, {'value': '59.7', 'spread': '26.5', 'groupId': 'OG001'}, {'value': '52.3', 'spread': '25.8', 'groupId': 'OG002'}]}]}, {'title': 'Pain at 2 hours', 'categories': [{'measurements': [{'value': '60.5', 'spread': '23.2', 'groupId': 'OG000'}, {'value': '62', 'spread': '26.0', 'groupId': 'OG001'}, {'value': '50.7', 'spread': '24.2', 'groupId': 'OG002'}]}]}, {'title': 'Pain at 3 hours', 'categories': [{'measurements': [{'value': '60', 'spread': '24.5', 'groupId': 'OG000'}, {'value': '55.3', 'spread': '27.1', 'groupId': 'OG001'}, {'value': '51.2', 'spread': '27.6', 'groupId': 'OG002'}]}]}, {'title': 'Pain at 4 hours', 'categories': [{'measurements': [{'value': '52.6', 'spread': '26.5', 'groupId': 'OG000'}, {'value': '50.3', 'spread': '28.7', 'groupId': 'OG001'}, {'value': '46.8', 'spread': '27.3', 'groupId': 'OG002'}]}]}, {'title': 'Pain at 5 hours', 'categories': [{'measurements': [{'value': '54.5', 'spread': '25.5', 'groupId': 'OG000'}, {'value': '48.6', 'spread': '24.1', 'groupId': 'OG001'}, {'value': '46.7', 'spread': '33.2', 'groupId': 'OG002'}]}]}, {'title': 'Pain at 6 hours', 'categories': [{'measurements': [{'value': '42.9', 'spread': '26.6', 'groupId': 'OG000'}, {'value': '37.3', 'spread': '22.3', 'groupId': 'OG001'}, {'value': '42.2', 'spread': '32.0', 'groupId': 'OG002'}]}]}, {'title': 'Pain at 12 hours', 'categories': [{'measurements': [{'value': '46.6', 'spread': '28.0', 'groupId': 'OG000'}, {'value': '35.8', 'spread': '22.7', 'groupId': 'OG001'}, {'value': '42.8', 'spread': '29.0', 'groupId': 'OG002'}]}]}, {'title': 'Pain at 72 hours', 'categories': [{'measurements': [{'value': '45.0', 'spread': '18.7', 'groupId': 'OG000'}, {'value': '41.1', 'spread': '18.1', 'groupId': 'OG001'}, {'value': '42.7', 'spread': '19.2', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'O hour, 1, 2, 3, 4, 5, 6, 12 and 72 hours.', 'description': 'Pain was measured via Visual Analong Scale in measurement (0-100mm).', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo Group', 'description': 'The placebo group will receive the same subacromial infusion catheter as the study group.However, the reservoir will be filled with 200cc of 0.9% normal saline.'}, {'id': 'FG001', 'title': 'Control Group', 'description': 'The control group patients will receive no continuous infusion catheter.'}, {'id': 'FG002', 'title': 'Study Group', 'description': 'Study group patients will receive a subacromial continuous standard spring loaded infusion catheter with 200cc of 0.5% bupivacaine in its reservoir. The infusion rate will be 4cc per hour.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '33'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '27'}, {'groupId': 'FG002', 'numSubjects': '32'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}], 'recruitmentDetails': 'Principal investigator recruited patients in clinic.', 'preAssignmentDetails': 'If patient met the inclusion criteria and agreed to participate, they were given the consent to sign and were randomized into the trial.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '88', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo Group', 'description': 'The placebo group will receive the same subacromial infusion catheter as the study group.However, the reservoir will be filled with 200cc of 0.9% normal saline.'}, {'id': 'BG001', 'title': 'Control Group', 'description': 'The control group patients will receive no continuous infusion catheter.'}, {'id': 'BG002', 'title': 'Study Group', 'description': 'Study group patients will receive a subacromial continuous standard spring loaded infusion catheter with 200cc of 0.5% bupivacaine in its reservoir. The infusion rate will be 4cc per hour.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '56', 'spread': '0.9', 'groupId': 'BG000'}, {'value': '58', 'spread': '0.6', 'groupId': 'BG001'}, {'value': '56', 'spread': '0.8', 'groupId': 'BG002'}, {'value': '57', 'spread': '0.8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '55', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '27', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '88', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-06', 'studyFirstSubmitDate': '2010-05-18', 'resultsFirstSubmitDate': '2013-11-06', 'studyFirstSubmitQcDate': '2010-05-18', 'lastUpdatePostDateStruct': {'date': '2014-11-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-11-06', 'studyFirstPostDateStruct': {'date': '2010-05-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Scores', 'timeFrame': 'O hour, 1, 2, 3, 4, 5, 6, 12 and 72 hours.', 'description': 'Pain was measured via Visual Analong Scale in measurement (0-100mm).'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Rotator Cuff Tear']}, 'descriptionModule': {'briefSummary': 'Subacromial pain catheters have been used with uncertain efficacy for many years after rotator cuff repair to aid in postoperative pain control. Our null hypothesis is that postoperative subacromial continuous infusion bupivacaine catheters will provide no pain control benefits over placebo infusions or no catheter use.', 'detailedDescription': 'This will be a prospective, randomized, double-blinded placebo controlled study. Randomization will be performed by a random numbers table. Envelopes will be sealed with the accompanying randomization group.Patients will be eligible for inclusion in the study if they have a full-thickness rotator cuff tear that has been deemed reparable by preoperative MRI. They will be included in the study if they are medically stable to undergo the surgery and consent to involvement in the study.\n\nPatients consenting to the study will undergo arthroscopic rotator cuff repair by one of the two senior authors. The surgery will be performed as an outpatient procedure under general anesthesia. The procedure will be performed utilizing the standard techniques of the senior authors. All concomitant pathology found at the time of arthroscopy will be treated in the usual appropriate fashion. At the completion of the rotator cuff repair, patients will be randomly allocated to one of three groups. This will be done by opening a sealed envelope with the randomization allocation. The patients will either be placed into the study group, the placebo group or the control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Full thickness rotator cuff tear\n* Pre operative MRI\n* Patients who are medically stable to undergo the surgery\n* Patients who consent to involvement in the study\n\nExclusion Criteria:\n\n* Prior surgery on the involved shoulder\n* Preoperative MRI suggesting that the rotator cuff tear is unrepairable\n* Patients with known allergies to oxycodone, bupivacaine or a similar drug\n* Workman's compensation patients\n* Patients who do not fill out their visual analog scores or their medication diaries."}, 'identificationModule': {'nctId': 'NCT01126593', 'briefTitle': 'Post-Op Rotator Cuff Pain Study With Subacromial Bupivacaine Infusion', 'organization': {'class': 'OTHER', 'fullName': 'Orlando Health, Inc.'}, 'officialTitle': 'Efficacy of Continuous Subacromial Bupivacaine Infusion for Postoperative Analgesia After Arthroscopic Rotator Cuff Repair.', 'orgStudyIdInfo': {'id': '708009'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo group', 'description': 'The placebo group will receive the same subacromial infusion catheter as the study group.However, the reservoir will be filled with 200cc of 0.9% normal saline.', 'interventionNames': ['Drug: Normal Saline']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'The control group patients will receive no continuous infusion catheter.'}, {'type': 'EXPERIMENTAL', 'label': 'Study Group', 'description': 'Study group patients will receive a subacromial continuous standard spring loaded infusion catheter with 200cc of 0.5% bupivacaine in its reservoir. The infusion rate will be 4cc per hour.', 'interventionNames': ['Drug: 0.5% bupivacaine']}], 'interventions': [{'name': '0.5% bupivacaine', 'type': 'DRUG', 'otherNames': ['Marcaine'], 'description': 'Study group patients will receive a subacromial continuous standard spring loaded infusion catheter with 200cc of 0.5% bupivacaine in its reservoir. The bupivacaine will have an infusion rate of 4cc an hour.', 'armGroupLabels': ['Study Group']}, {'name': 'Normal Saline', 'type': 'DRUG', 'otherNames': ['Saline'], 'description': 'The placebo group will receive the same subacromial infusion catheter however, the reservoir will be filled with 200cc of 0.9% Normal Saline.', 'armGroupLabels': ['Placebo group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Orlando Orthopaedic Center', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}], 'overallOfficials': [{'name': 'Randy Schwartzberg, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Orlando Orthopaedic Center and Orlando Health, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Orlando Health, Inc.', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Orthopedic surgeon, Orlando Orthopaedic Center', 'investigatorFullName': 'Paula J. Harriott', 'investigatorAffiliation': 'Orlando Health, Inc.'}}}}