Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2025-12-29 @ 2:19 PM
Study NCT ID:
NCT01303003
Status:
COMPLETED
Last Update Posted:
2018-09-21
First Post:
2011-02-23
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Evaluation of Addition of Dexamethasone to Transversus Abdominis Plane (TAP) Peripheral Nerve Block
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'meghan.cashman@steward.org', 'phone': '617-789-2804', 'title': 'Meghan Cashman, IRB Manager', 'phoneExt': '2804', 'organization': "Steward St. Elizabeth's Medical Center"}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'description': 'No data are available for this study, due to the fact that the PI has left the institution. Multiple efforts were made, by Research and senior leadership, to contact the PI, prior to and after his leaving the institution, with no response. Sincere efforts were made to obtain the data for reporting, but the data is unavailable.', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment Arm 1', 'description': 'Bilateral TAP block consisting of 40cc. 0.125% bupivicaine + 0.5cc. dexamethasone (2mg.) per side.\n\nDexamethasone: 40 cc. 0.125% bupivicaine + 0.5cc. dexamethasone (2mg.) per side.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Treatment Arm 2', 'description': 'Bilateral TAP block of 40cc. of 0.125% bupivicaine + 0.5cc. sterile saline per side\n\nTAP block: Bilateral TAP block of 40cc. of 0.125% bupivicaine + 0.5cc. sterile saline per side', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Time to First Request of Additional Analgesia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm 1', 'description': 'Bilateral TAP block consisting of 40cc. 0.125% bupivicaine + 0.5cc. dexamethasone (2mg.) per side.\n\nDexamethasone: 40 cc. 0.125% bupivicaine + 0.5cc. dexamethasone (2mg.) per side.'}, {'id': 'OG001', 'title': 'Treatment Arm 2', 'description': 'Bilateral TAP block of 40cc. of 0.125% bupivicaine + 0.5cc. sterile saline per side\n\nTAP block: Bilateral TAP block of 40cc. of 0.125% bupivicaine + 0.5cc. sterile saline per side'}], 'timeFrame': '24 hours post-op', 'description': 'Documenting the time required by patients to the first request of additional analgesia.', 'reportingStatus': 'POSTED', 'populationDescription': 'No data are available for this study, due to the fact that the PI has left the institution. Multiple efforts were made, by Research and senior leadership, to contact the PI, prior to and after his leaving the institution, with no response. Sincere efforts were made to obtain the data for reporting, but the data is unavailable.'}, {'type': 'SECONDARY', 'title': 'Assess the Efficacy of the TAP Block by Measuring Visual Analog Scales, Total Opioid Use During the First 24 Hours Post-op, and Provider Assessments to Recognize the Overall Efficacy of the Procedure With and Without Dexamethasone Adjunct.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm 1', 'description': 'Bilateral TAP block consisting of 40cc. 0.125% bupivicaine + 0.5cc. dexamethasone (2mg.) per side.\n\nDexamethasone: 40 cc. 0.125% bupivicaine + 0.5cc. dexamethasone (2mg.) per side.'}, {'id': 'OG001', 'title': 'Treatment Arm 2', 'description': 'Bilateral TAP block of 40cc. of 0.125% bupivicaine + 0.5cc. sterile saline per side\n\nTAP block: Bilateral TAP block of 40cc. of 0.125% bupivicaine + 0.5cc. sterile saline per side'}], 'timeFrame': '24 hours post-op', 'reportingStatus': 'POSTED', 'populationDescription': 'No data are available for this study, due to the fact that the PI and study staff have left the institution. Multiple efforts were made, by Research and senior leadership, to contact the PI, prior to and after his leaving the institution, with no response. Sincere efforts were made to obtain the data for reporting, but the data is unavailable.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Arm 1', 'description': 'Bilateral TAP block consisting of 40cc. 0.125% bupivicaine + 0.5cc. dexamethasone (2mg.) per side.\n\nDexamethasone: 40 cc. 0.125% bupivicaine + 0.5cc. dexamethasone (2mg.) per side.'}, {'id': 'FG001', 'title': 'Treatment Arm 2', 'description': 'Bilateral TAP block of 40cc. of 0.125% bupivicaine + 0.5cc. sterile saline per side\n\nTAP block: Bilateral TAP block of 40cc. of 0.125% bupivicaine + 0.5cc. sterile saline per side'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'No data are available for this study, due to the fact that the PI has left the institution. Multiple efforts were made, by Research and senior leadership, to contact the PI, prior to and after his leaving the institution, with no response. Sincere efforts were made to obtain the data for reporting, but the data is unavailable.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment Arm 1', 'description': 'Bilateral TAP block consisting of 40cc. 0.125% bupivicaine + 0.5cc. dexamethasone (2mg.) per side.\n\nDexamethasone: 40 cc. 0.125% bupivicaine + 0.5cc. dexamethasone (2mg.) per side.'}, {'id': 'BG001', 'title': 'Treatment Arm 2', 'description': 'Bilateral TAP block of 40cc. of 0.125% bupivicaine + 0.5cc. sterile saline per side\n\nTAP block: Bilateral TAP block of 40cc. of 0.125% bupivicaine + 0.5cc. sterile saline per side'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years'}, {'title': 'Between 18 and 65 years'}, {'title': '>=65 years'}]}]}, {'title': 'Age, Continuous'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female'}, {'title': 'Male'}]}]}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States'}], 'unitOfMeasure': 'participants'}], 'populationDescription': 'No data are available for this study, due to the fact that the PI has left the institution. Multiple efforts were made, by Research and senior leadership, to contact the PI, prior to and after his leaving the institution, with no response. Sincere efforts were made to obtain the data for reporting, but the data is unavailable.'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-14', 'studyFirstSubmitDate': '2011-02-23', 'resultsFirstSubmitDate': '2018-09-14', 'studyFirstSubmitQcDate': '2011-02-23', 'lastUpdatePostDateStruct': {'date': '2018-09-21', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-09-14', 'studyFirstPostDateStruct': {'date': '2011-02-24', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to First Request of Additional Analgesia', 'timeFrame': '24 hours post-op', 'description': 'Documenting the time required by patients to the first request of additional analgesia.'}], 'secondaryOutcomes': [{'measure': 'Assess the Efficacy of the TAP Block by Measuring Visual Analog Scales, Total Opioid Use During the First 24 Hours Post-op, and Provider Assessments to Recognize the Overall Efficacy of the Procedure With and Without Dexamethasone Adjunct.', 'timeFrame': '24 hours post-op'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Prostate CA']}, 'descriptionModule': {'briefSummary': 'Transversus abdominis plane (TAP) blocks are increasingly being performed after abdominal surgery to provide post operative analgesia. Dexamethasone has demonstrated an ability to prolong the effective duration of analgesia in several different peripheral nerve blocks. The study will examine, in a blinded, prospective and randomized fashion, whether the addition of dexamethasone to TAP blocks similarly prolongs blockade and pain relief. The study will compare local anesthetic with and without the addition of dexamethasone in the TAP block.', 'detailedDescription': "The study will be done in two phases. In the first phase, patients will be randomized to receive either 20 cc of 0.125% bupivicaine with or without 2 mg of dexamethasone on each side of their abdomen (40 cc and 4 mg in total) and patients who receive the dexamethasone will be compared with patients who did not receive it. In the second phase, we will assess whether patients can serve as their own controls by adding dexamethasone only to one side of the block (one side of the abdomen) and comparing pain relief/efficacy with the contra-lateral plain local anesthetic effect. The study will assess pain relief, opioid consumption, level of blockade, and operator's prospective assessment of likely efficacy, based on the ultrasound visualization of the local anesthetic injection as compared with actual efficacy."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male patients, between ages 18-85 years old, undergoing Robot-assisted laparoscopic prostatectomy by a single surgeon at a single hospital.\n* Subjects are physically and mentally able to participate in the study.\n* Subjects are able to give fully informed consent to participating in this study after demonstrating good understanding of the risks and benefits of the proposed components of the TAP block.\n\nExclusion Criteria:\n\n* Demonstrated hypersensitivity or allergy to local anesthetics or dexamethasone.\n* Any subject whose anatomy, or surgical procedure, in the opinion of the investigator, might preclude the potential successful performance of a TAP block.\n* Any subject, who in the opinion of the investigator, might be harmed or be a poor candidate for participation in the study.'}, 'identificationModule': {'nctId': 'NCT01303003', 'briefTitle': 'Evaluation of Addition of Dexamethasone to Transversus Abdominis Plane (TAP) Peripheral Nerve Block', 'organization': {'class': 'OTHER', 'fullName': "Steward St. Elizabeth's Medical Center of Boston, Inc."}, 'officialTitle': 'Evaluation of Addition of Dexamethasone to Transversus Abdominis Plane (TAP) Peripheral Nerve Block: Does it Enhance the Quality and Duration of Analgesia?', 'orgStudyIdInfo': {'id': 'TAP-00560'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Arm 1', 'description': 'Bilateral TAP block consisting of 40cc. 0.125% bupivicaine + 0.5cc. dexamethasone (2mg.) per side.', 'interventionNames': ['Drug: Dexamethasone']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment Arm 2', 'description': 'Bilateral TAP block of 40cc. of 0.125% bupivicaine + 0.5cc. sterile saline per side', 'interventionNames': ['Procedure: TAP block']}], 'interventions': [{'name': 'Dexamethasone', 'type': 'DRUG', 'description': '40 cc. 0.125% bupivicaine + 0.5cc. dexamethasone (2mg.) per side.', 'armGroupLabels': ['Treatment Arm 1']}, {'name': 'TAP block', 'type': 'PROCEDURE', 'description': 'Bilateral TAP block of 40cc. of 0.125% bupivicaine + 0.5cc. sterile saline per side', 'armGroupLabels': ['Treatment Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02135', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "St. Elizabeth's Medical Center of Boston", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}], 'overallOfficials': [{'name': 'Andrew Sternlicht, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "St. Elizabeth's Medical Center of Boston"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Steward St. Elizabeth's Medical Center of Boston, Inc.", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}