Ignite Creation Date:
2025-12-25 @ 2:16 AM
Ignite Modification Date:
2025-12-31 @ 12:57 PM
Study NCT ID:
NCT05005260
Status:
COMPLETED
Last Update Posted:
2024-05-07
First Post:
2021-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Liposomal Bupivacaine Single-Injection Interscalene Block vs. Continuous Interscalene Block for Primary Total Shoulder Arthroplasty
Sponsor:
Organization:
Raw JSON
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{'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Paul.Johar@mayo.edu', 'phone': '5072556804', 'title': 'Johar Paul', 'organization': 'Mayo Clinic'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'First 3 days after surgery', 'eventGroups': [{'id': 'EG000', 'title': 'Liposomal Bupivacaine Single-shot Interscalene Blockade', 'description': 'Subjects will receive a preoperative single-injection interscalene nerve block with long-acting numbing medicine, liposomal bupivacaine\n\nLiposomal bupivacaine + Bupivacaine Hcl 0.5% Inj: Subjects will receive a one-time interscalene nerve block injection of 5 mL of bupivacaine 0.5% (25 mg) admixed with 10 mL of liposomal bupivacaine (133 mg).', 'otherNumAtRisk': 39, 'deathsNumAtRisk': 39, 'otherNumAffected': 0, 'seriousNumAtRisk': 39, 'deathsNumAffected': 0, 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39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Non-functioning catheter', 'stats': [{'groupId': 'EG000', 'numAtRisk': 39, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 44, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Pain Intensity Score at Rest at 24 Hours Post-operatively', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Liposomal Bupivacaine Single-shot Interscalene Blockade', 'description': 'Subjects will receive a preoperative single-injection interscalene nerve block with long-acting numbing medicine, liposomal bupivacaine\n\nLiposomal bupivacaine + Bupivacaine Hcl 0.5% Inj: Subjects will receive a one-time interscalene nerve block injection of 5 mL of bupivacaine 0.5% (25 mg) admixed with 10 mL of liposomal bupivacaine (133 mg).'}, {'id': 'OG001', 'title': 'Continuous Interscalene Nerve Blockade', 'description': 'Subjects will receive a preoperative interscalene nerve block with a continuous catheter device which provides local anesthetic, bupivacaine, for up to 3 days.\n\nBupivacaine HCl: Subjects randomized to the continuous interscalene nerve block group will receive a loading dose of 15-20 mL bupivacaine HCl 0.5% followed by a continuous catheter infusion of bupivacaine 0.2% at 8 mL per hour for 72 hours.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '3'}, {'value': '1', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '2'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Post-Operative Day 1', 'description': 'Self-reported pain intensity scores measure using numerical rating scale of 0 (no pain) to 10 (worst pain imaginable). 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The 11-point numerical rating scale leads to a minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery).', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Liposomal Bupivacaine Single-shot Interscalene Blockade', 'description': 'Subjects will receive a preoperative single-injection interscalene nerve block with long-acting numbing medicine, liposomal bupivacaine\n\nLiposomal bupivacaine + Bupivacaine Hcl 0.5% Inj: Subjects will receive a one-time interscalene nerve block injection of 5 mL of bupivacaine 0.5% (25 mg) admixed with 10 mL of liposomal bupivacaine (133 mg).'}, {'id': 'FG001', 'title': 'Continuous Interscalene Nerve Blockade', 'description': 'Subjects will receive a preoperative interscalene nerve block with a continuous catheter device which provides local anesthetic, bupivacaine, for up to 3 days.\n\nBupivacaine HCl: Subjects randomized to the continuous interscalene nerve block group will receive a loading dose of 15-20 mL bupivacaine HCl 0.5% followed by a continuous catheter infusion of bupivacaine 0.2% at 8 mL per hour for 72 hours.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '42'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '39'}, {'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Liposomal Bupivacaine Single-shot Interscalene Blockade', 'description': 'Subjects will receive a preoperative single-injection interscalene nerve block with long-acting numbing medicine, liposomal bupivacaine\n\nLiposomal bupivacaine + Bupivacaine Hcl 0.5% Inj: Subjects will receive a one-time interscalene nerve block injection of 5 mL of bupivacaine 0.5% (25 mg) admixed with 10 mL of liposomal bupivacaine (133 mg).'}, {'id': 'BG001', 'title': 'Continuous Interscalene Nerve Blockade', 'description': 'Subjects will receive a preoperative interscalene nerve block with a continuous catheter device which provides local anesthetic, bupivacaine, for up to 3 days.\n\nBupivacaine HCl: Subjects randomized to the continuous interscalene nerve block group will receive a loading dose of 15-20 mL bupivacaine HCl 0.5% followed by a continuous catheter infusion of bupivacaine 0.2% at 8 mL per hour for 72 hours.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '72', 'groupId': 'BG000', 'lowerLimit': '66', 'upperLimit': '76'}, {'value': '69', 'groupId': 'BG001', 'lowerLimit': '66', 'upperLimit': '76'}, {'value': '71', 'groupId': 'BG002', 'lowerLimit': '66', 'upperLimit': '76'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '37', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'ASA Score', 'classes': [{'title': 'ASA 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'ASA 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}, {'title': 'ASA 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'BG000'}, {'value': '44', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '36', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'The American Society of Anesthesiologists (ASA) Physical Status Classification System is a tool used in preparation for surgery to help predict risks in a given patient. The following are classification definitions: ASA 1 - a normal healthy patient, ASA 2 - a patient with mild systemic disease, ASA 3 - a patient with severe systemic disease, ASA 4 - a patient with severe systemic disease that is a constant threat to life, ASA 5 - a moribund patient who is not expected to survive without the operation, ASA 6 - a declared brain-dead patient whose organs are being removed for donor purposes', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-07-02', 'size': 804175, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-11-05T14:40', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Unblinded'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-03-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-15', 'studyFirstSubmitDate': '2021-08-08', 'resultsFirstSubmitDate': '2023-11-05', 'studyFirstSubmitQcDate': '2021-08-08', 'lastUpdatePostDateStruct': {'date': '2024-05-07', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-12-15', 'studyFirstPostDateStruct': {'date': '2021-08-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-12-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-03-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain Intensity Score at Rest at 24 Hours Post-operatively', 'timeFrame': 'Post-Operative Day 1', 'description': 'Self-reported pain intensity scores measure using numerical rating scale of 0 (no pain) to 10 (worst pain imaginable). Primary outcome was measured at 24 hours postoperative time point.'}], 'secondaryOutcomes': [{'measure': 'Cumulative Opioid Consumption', 'timeFrame': 'PACU to postoperative day 3', 'description': 'Reported in mg oral morphine equivalents (OME); measured from PACU through postoperative day 3'}, {'measure': 'Quality of Recovery Score (QoR)', 'timeFrame': 'Post-Operative Day 1', 'description': '15 item short form patient survey using a scoring system evaluating 5 dimensions of health: psychological support, comfort, emotions, physical independence, and pain. The 11-point numerical rating scale leads to a minimum score of 0 (very poor recovery) and a maximum score of 150 (excellent recovery).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Interscalene nerve block', 'total shoulder arthroplasty', 'pain management', 'OBAS', 'QoR-15'], 'conditions': ['Pain, Postoperative', 'Brachial Plexus Block']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mayo.edu/research/clinical-trials', 'label': 'Mayo Clinic Clinical Trials'}]}, 'descriptionModule': {'briefSummary': 'This study aims to assess analgesia efficacy between liposomal bupivacaine single injection interscalene blockade vs. continuous interscalene nerve block for patients undergoing primary total shoulder arthroplasty.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria\n\n* Adult patients with an American Society of Anesthesiologists (ASA) physiological status I-III\n* Patients presenting for unilateral primary total shoulder arthroplasty (includes anatomic and reverse total shoulder arthroplasty).\n* Patients 18 years of age and older\n* Able to provide informed consent for him or herself\n\nExclusion Criteria\n\n* Chronic pain syndromes\n* Chronic opioid use (\\>1 month) with OME \\>5 mg/day OR acute opioid use (\\< 1 month) with OME \\> 30 mg/day.\n* Body mass index (BMI) \\> 45 kg/m2\n* Severe drug allergy\\* to medications used in this study, including non-steroidal anti-inflammatory drugs (i.e. celecoxib) and local anesthetics. \\*defined as an immune reaction resulting in shortness of breath, hives, anaphylaxis, wheezing, and fever\n* Personal or family history of malignant hyperthermia.\n* Major systemic medical problems such as:\n\n * Pre-existing severe renal disorder defined as glomerular filtration rate (GFR) \\<50 units/m2 (if labs are available), currently on dialysis, or highly suspected based on history.\n * Severe hepatic disorder defined as current or past diagnosis of acute/subacute necrosis of liver, acute hepatic failure, chronic liver disease, cirrhosis (primary biliary cirrhosis), chronic hepatitis/toxic hepatitis, liver abscess, hepatic coma, hepatorenal syndrome, other disorders of liver\n * Pre-existing medical history of moderate to severe pulmonary disease requiring medical therapy (obstructive and/or restrictive), use of home oxygen, preoperative baseline oxygen saturation \\< 93% on room air.\n * History of contralateral hemidiaphragm dysfunction (e.g., paralysis) or phrenic nerve injury.\n* Contraindication to a regional anesthesia technique (e.g., preexisting neuropathy+ in the operative extremity, coagulopathy, sepsis, infection at site of injection, uncooperative, and refusal).\n\n o + pre-existing neuropathy includes sensory and/or motor deficits due to nerve insult of surgical extremity, radicular symptoms of surgical extremity, history of unresolved brachial plexus injury/brachial plexopathy, and tumors of the brachial plexus. Patients with nerve compression distal to site of surgery, such as history of carpal tunnel syndrome or cubital tunnel syndrome, are NOT considered contraindications to regional anesthesia.\n* Known to be currently pregnant or actively breastfeeding++\n\n o ++ All surgical patients are currently screened using a standardized Pregnancy Assessment tool (http://mayoweb.mayo.edu/sp-forms/mc8800-mc8899/mc8801-161.pdf)\n* Impaired cognition (e.g. Alzheimer's disease, moderate to severe dementia, encephalopathy)\n* Non-English speaking"}, 'identificationModule': {'nctId': 'NCT05005260', 'briefTitle': 'Liposomal Bupivacaine Single-Injection Interscalene Block vs. Continuous Interscalene Block for Primary Total Shoulder Arthroplasty', 'organization': {'class': 'OTHER', 'fullName': 'Mayo Clinic'}, 'officialTitle': 'Prospective, Randomized Clinical Trial Comparing Analgesic Efficacy of Liposomal Bupivacaine Single-Injection Interscalene Blockade to Continuous Interscalene Blockade for Patients Undergoing Primary Total Shoulder Arthroplasty', 'orgStudyIdInfo': {'id': '21-000908'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'liposomal bupivacaine single-shot interscalene blockade', 'description': 'Subjects will receive a preoperative single-injection interscalene nerve block with long-acting numbing medicine, liposomal bupivacaine', 'interventionNames': ['Drug: Liposomal bupivacaine + Bupivacaine Hcl 0.5% Inj']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'continuous interscalene nerve blockade', 'description': 'Subjects will receive a preoperative interscalene nerve block with a continuous catheter device which provides local anesthetic, bupivacaine, for up to 3 days.', 'interventionNames': ['Drug: Bupivacaine HCl']}], 'interventions': [{'name': 'Bupivacaine HCl', 'type': 'DRUG', 'description': 'Subjects randomized to the continuous interscalene nerve block group will receive a loading dose of 15-20 mL bupivacaine HCl 0.5% followed by a continuous catheter infusion of bupivacaine 0.2% at 8 mL per hour for 72 hours.', 'armGroupLabels': ['continuous interscalene nerve blockade']}, {'name': 'Liposomal bupivacaine + Bupivacaine Hcl 0.5% Inj', 'type': 'DRUG', 'description': 'Subjects will receive a one-time interscalene nerve block injection of 5 mL of bupivacaine 0.5% (25 mg) admixed with 10 mL of liposomal bupivacaine (133 mg).', 'armGroupLabels': ['liposomal bupivacaine single-shot interscalene blockade']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic in Rochester', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}], 'overallOfficials': [{'name': 'Jason K Panchamia, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Mayo Clinic'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mayo Clinic', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jason K. Panchamia, D.O.', 'investigatorAffiliation': 'Mayo Clinic'}}}}