Ignite Creation Date:
2025-12-25 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 10:40 PM
Study NCT ID:
NCT04585867
Status:
UNKNOWN
Last Update Posted:
2020-10-14
First Post:
2020-09-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Liposomal Bupivacaine vs Bupivacaine for Pain Control After Sternotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, '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': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-10-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2023-10-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-12', 'studyFirstSubmitDate': '2020-09-24', 'studyFirstSubmitQcDate': '2020-10-12', 'lastUpdatePostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-10', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Opioid consumption in morphine equivalents', 'timeFrame': '0 hours post-surgery', 'description': 'Opioid consumption in morphine equivalents'}, {'measure': 'Opioid consumption in morphine equivalents', 'timeFrame': '12 hours post-surgery', 'description': 'Opioid consumption in morphine equivalents'}, {'measure': 'Opioid consumption in morphine equivalents', 'timeFrame': '24 hours post-surgery', 'description': 'Opioid consumption in morphine equivalents'}, {'measure': 'Opioid consumption in morphine equivalents', 'timeFrame': '36 hours post-surgery', 'description': 'Opioid consumption in morphine equivalents'}, {'measure': 'Opioid consumption in morphine equivalents', 'timeFrame': '48 hours post-surgery', 'description': 'Opioid consumption in morphine equivalents'}, {'measure': 'Opioid consumption in morphine equivalents', 'timeFrame': '60 hours post-surgery', 'description': 'Opioid consumption in morphine equivalents'}, {'measure': 'Opioid consumption in morphine equivalents', 'timeFrame': '72 hours post-surgery', 'description': 'Opioid consumption in morphine equivalents'}], 'secondaryOutcomes': [{'measure': 'Time to extubation in minutes will be retrieved via the electronic medical record', 'timeFrame': '30 days post operative', 'description': 'Time to extubation in minutes will be retrieved via the electronic medical record'}, {'measure': 'Presence of sternal wound infection', 'timeFrame': '4-6 weeks postoperative visit', 'description': 'Presence of sternal wound infection will be retrieved via electronic medical record and at 30 day follow up for Society of Thoracic Surgery (STS) database data as well as sternal infection documented at standard postoperative visit at 4-6 weeks'}, {'measure': 'Postoperative delirium as assessed by Confusion Assessment Method (CAM)-ICU', 'timeFrame': '30 days post operative', 'description': 'Postoperative delirium as assessed by CAM-ICU at hours 0,12,24,36,48,60,and 72 hours post-surgery will be retrieved via the electronic medical record'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain Management', 'Sternotomy']}, 'descriptionModule': {'briefSummary': 'Researchers hope to learn whether giving the longer-acting local anesthetic liposomal bupivacaine prior to closing the sternum is more effective in managing pain following sternotomy, than in patients who received standard bupivacaine before sternal closure. Researchers will measure this based on how much IV pain medication is used, rates on confusion, and time to remove the breathing tube.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults over the age of 18 who present for elective open heart surgery that requires a sternotomy.\n\nExclusion Criteria:\n\n* Urgent and emergency procedures,\n* preexisting sternal infections,\n* prior sternotomy,\n* preexisting pain syndromes,\n* current chronic home opioid use,\n* anterior rib or sternal masses,\n* allergy to any of the components of liposomal bupivacaine and plain bupivacaine.'}, 'identificationModule': {'nctId': 'NCT04585867', 'briefTitle': 'Liposomal Bupivacaine vs Bupivacaine for Pain Control After Sternotomy', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'Liposomal Bupivacaine vs Bupivacaine for Pain Control After Sternotomy', 'orgStudyIdInfo': {'id': 'STUDY00140472'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Liposomal bupivacaine', 'description': 'Exparel (266mg) given by surgeon just prior to sternal closure', 'interventionNames': ['Drug: Exparel']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Bupivacaine', 'description': '40ml of 0.125% bupivacaine given by surgeon just prior to sternal closure', 'interventionNames': ['Drug: Bupivacaine']}], 'interventions': [{'name': 'Exparel', 'type': 'DRUG', 'description': 'The injections will be performed under direct guidance by the cardiac surgeon at bilateral sternal-costal interspaces 1.5 cm lateral the sternal boarder at levels 2-6 in divided doses (2 ml/injection) just before the closure of the sternum near the end of the surgical procedure. The final 20 ml will be injected into the skin incision after closure', 'armGroupLabels': ['Liposomal bupivacaine']}, {'name': 'Bupivacaine', 'type': 'DRUG', 'description': 'The injections will be performed under direct guidance by the cardiac surgeon at bilateral sternal-costal interspaces 1.5 cm lateral the sternal boarder at levels 2-6 in divided doses (2 ml/injection) just before the closure of the sternum near the end of the surgical procedure. The final 20 ml will be injected into the skin incision after closure', 'armGroupLabels': ['Bupivacaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Abigail Houchin', 'role': 'CONTACT', 'email': 'ahouchin@kumc.edu'}], 'facility': 'University of Kansas Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'centralContacts': [{'name': 'Angie Ballew, DC, MS', 'role': 'CONTACT', 'email': 'aballew@kumc.edu', 'phone': '9139457420'}], 'overallOfficials': [{'name': 'Jared Staab, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Study Principal Investigator', 'investigatorFullName': 'Jared Staab, DO', 'investigatorAffiliation': 'University of Kansas Medical Center'}}}}