Ignite Creation Date:
2025-12-24 @ 2:28 PM
Ignite Modification Date:
2026-01-02 @ 10:36 AM
Study NCT ID:
NCT04382859
Status:
UNKNOWN
Last Update Posted:
2020-11-27
First Post:
2020-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TOTEM: Trial of TAP Block Effective Medications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003766', 'term': 'Dental Occlusion'}], 'ancestors': [{'id': 'D003813', 'term': 'Dentistry'}, {'id': 'D009063', 'term': 'Dental Physiological Phenomena'}, {'id': 'D055688', 'term': 'Digestive System and Oral Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 56}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2021-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-11-23', 'studyFirstSubmitDate': '2020-03-01', 'studyFirstSubmitQcDate': '2020-05-08', 'lastUpdatePostDateStruct': {'date': '2020-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain rating 1 hour post operation', 'timeFrame': '1 hour post operation', 'description': 'Participant-reported pain rating on a numeric 0 - 10 scale, with rating of 0 representing no pain and rating 10 representing worst pain'}, {'measure': 'Pain rating 2 hours post operation', 'timeFrame': '2 hours post operation', 'description': 'Participant-reported pain rating on a numeric 0 - 10 scale, with rating of 0 representing no pain and rating 10 representing worst pain'}, {'measure': 'Pain rating 4 hours post operation', 'timeFrame': '4 hours post operation', 'description': 'Participant-reported pain rating on a numeric 0 - 10 scale, with rating of 0 representing no pain and rating 10 representing worst pain'}, {'measure': 'Pain rating 72 hours post operation', 'timeFrame': '72 hours post operation', 'description': 'Participant-reported pain rating on a numeric 0 - 10 scale, with rating of 0 representing no pain and rating 10 representing worst pain'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'Our goal is to determine if liposomal bupivacaine compared to standard bupivacaine results in increased pain control and decreased narcotic pain medication use when used in TAP blocks prior to laparoscopic hysterectomies for benign indications.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women undergoing non robotic assisted laparoscopic surgery for benign gynecologic conditions\n* English speaking\n\nExclusion Criteria:\n\n* Known current malignancy\n* Contraindication to medications'}, 'identificationModule': {'nctId': 'NCT04382859', 'acronym': 'TOTEM', 'briefTitle': 'TOTEM: Trial of TAP Block Effective Medications', 'organization': {'class': 'OTHER', 'fullName': 'Western Michigan University School of Medicine'}, 'officialTitle': 'TOTEM: Trial of TAP Block Effective Medications', 'orgStudyIdInfo': {'id': 'WMed-2020-0601'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'TAP block with liposomal bupivacaine', 'description': 'Active comparator', 'interventionNames': ['Procedure: Transversus abdominis plane (TAP) block with liposomal bupivacaine']}, {'type': 'OTHER', 'label': 'TAP block with 0.25% bupivacaine', 'description': 'Standard comparator', 'interventionNames': ['Procedure: Transversus abdominis plane (TAP) block with liposomal bupivacaine']}], 'interventions': [{'name': 'Transversus abdominis plane (TAP) block with liposomal bupivacaine', 'type': 'PROCEDURE', 'description': 'Transversus abdominis plane (TAP) blocks are safe and effective procedures for the provision of postoperative pain management following abdominal procedures (3) and have been widely used across specialties with reduction in postoperative pain and narcotic use (4-7).', 'armGroupLabels': ['TAP block with 0.25% bupivacaine', 'TAP block with liposomal bupivacaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49007', 'city': 'Kalamazoo', 'state': 'Michigan', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Melinda Abernethy, MD', 'role': 'CONTACT', 'email': 'melnda.abernethy@med.wmich.edu', 'phone': '919-260-9328'}], 'facility': 'Bronson Methodist Hospital', 'geoPoint': {'lat': 42.29171, 'lon': -85.58723}}], 'centralContacts': [{'name': 'Melinda Abernethy, MD', 'role': 'CONTACT', 'email': 'melinda.abernethy@med.wmich.edu', 'phone': '(919) 260-9328'}], 'overallOfficials': [{'name': 'Melinda Abernethy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Western Michigan University Homer Stryker M.D. School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Western Michigan University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Melinda Abernethy', 'investigatorAffiliation': 'Western Michigan University School of Medicine'}}}}