Ignite Creation Date:
2025-12-25 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 9:57 PM
Study NCT ID:
NCT04849858
Status:
TERMINATED
Last Update Posted:
2024-08-23
First Post:
2021-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pilot Study of Liposomal Bupivacaine Redosing in Patients Undergoing Major Gynecologic Procedures
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010051', 'term': 'Ovarian Neoplasms'}, {'id': 'D007889', 'term': 'Leiomyoma'}, {'id': 'D014594', 'term': 'Uterine Neoplasms'}], 'ancestors': [{'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D005833', 'term': 'Genital Neoplasms, Female'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D009379', 'term': 'Neoplasms, Muscle Tissue'}, {'id': 'D018204', 'term': 'Neoplasms, Connective and Soft Tissue'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D014591', 'term': 'Uterine Diseases'}]}, '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': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'This is a prospective cohort study with retrospective data analysis. Patients will be assigned to treatment groups on a consecutive basis. We will be recruiting 45 eligible patients from our University of California Irvine (UCI) gynecologic oncology clinic. Each clinic patient who is scheduled for surgery will be screened for eligibility. The first 15 patients enrolled will receive perioperative plain bupivacaine transversus abdominis plane (TAP) blocks. The next 15 patients enrolled will receive perioperative single-dose Liposomal Bupivacaine (LB) TAP blocks. The final 15 patients enrolled will receive perioperative LB TAP blocks followed by redosing of the TAP blocks in 48-60 hours.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'whyStopped': 'Low recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-05-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2023-01-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-22', 'studyFirstSubmitDate': '2021-04-16', 'studyFirstSubmitQcDate': '2021-04-16', 'lastUpdatePostDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-01-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post-operative opioid consumption', 'timeFrame': 'Post-operative day 0 to day 8', 'description': 'Morphine equivalents (milligrams)'}], 'secondaryOutcomes': [{'measure': 'Pain at rest and during activity', 'timeFrame': 'Post-operative day 0 to day 8', 'description': 'Measured pain on a Visual Analog Scale (VAS), Scale 0 (no pain) - 10 (high pain)'}, {'measure': 'Nausea/Vomiting', 'timeFrame': 'Post-operative day 0 to day 8', 'description': 'Presence or Absence of nausea or vomiting'}, {'measure': 'Ileus', 'timeFrame': 'Post-operative day 0 to day 8', 'description': 'Presence or Absence of Ileus'}, {'measure': 'Bowel Function', 'timeFrame': 'Post-operative day 0 to day 8', 'description': 'Time to return of bowel function (days)'}, {'measure': 'Ambulation', 'timeFrame': 'Post-operative day 0 to day 8', 'description': 'Time to first ambulation (days)'}, {'measure': 'Hospital stay', 'timeFrame': 'Post-operative day 0 to day 8', 'description': 'Length of hospital stay (days)'}, {'measure': 'Surgical Adverse Events', 'timeFrame': 'Post-operative day 0 to day 8', 'description': 'Presence or Absence of adverse events'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ovarian cancer', 'fibroids', 'uterine cancer', 'Transverse abdominis plane block', 'TAP block'], 'conditions': ['Ovarian Cancer', 'Fibroids', 'Uterine Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to find out which type of transversus abdomens plane (TAP) and block (bupivacaine, liposomal bupivacaine or liposomal bupivacaine with re-dosing at 48-60 hours) improves your pain control and lowers your risk of post-operative common side effects of surgery and narcotic pain medications.', 'detailedDescription': 'The purpose of this research study is to find out which type of TAP block (bupivacaine, liposomal bupivacaine or liposomal bupivacaine with re-dosing at 48-60 hours) improves your pain control and lowers your risk of post-operative common side effects of surgery and narcotic pain medications.\n\nAn anesthesiologist participating on this study will describe the TAP block to you during your preoperative interview and will obtain your consent for the block procedure with your anesthesia consent prior to the procedure. TAP blocks are one of the various methods of controlling your pain after surgery. They are typically placed with an anesthetic agent, such as bupivacaine. The U.S. Food and Drug Administration (FDA) has recently approved a longer-acting form of the anesthetic used in this study, liposomal bupivacaine. Although both medications, bupivacaine and liposomal bupivacaine are approved by the FDA, there are only a few trials such as this one, in the United States, comparing the various types of TAP blocks. No studies exist comparing the re-dosing of a TAP block, as we will be doing in this study.\n\nCurrently, the standard of care after a gynecologic procedure may or may not include receiving a TAP block. This was a decision typically made, with your consent, at the discretion of an anesthesiologist and your surgeon. As per the standard of care, after surgery, you would be given oral pain medications to control your pain and intravenous pain medications for severe breakthrough pain. Our study will not change your post-operative pain medication schedule or timing. It will only study the effectiveness of the TAP block you get in controlling your pain.\n\nEven though the medicines (bupivacaine or liposomal bupivacaine) used in this study are FDA-approved, the use of these drugs in this study is investigational.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'This study applies to patients receiving care with a gynecologic oncologist', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Age ≥ 18 years old\n* Must be undergoing an open gynecologic procedure through a midline vertical incision with a gynecologic oncologist\n\nExclusion Criteria\n\n* History of chronic pain\n* History of opioid dependence\n* Suspected or confirmed history of endometriosis\n* History of fibromyalgia\n* Suspected or confirmed interstitial cystitis or painful bladder syndrome\n* History of or current opioid use prior to surgery\n* Hypersensitivity to bupivacaine\n* Severe hepatic or renal disease'}, 'identificationModule': {'nctId': 'NCT04849858', 'briefTitle': 'Pilot Study of Liposomal Bupivacaine Redosing in Patients Undergoing Major Gynecologic Procedures', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Irvine'}, 'officialTitle': 'Pilot Study of Liposomal Bupivacaine Redosing in Patients Undergoing Major Gynecologic Procedures: A Quality Improvement Project in Post-operative Pain', 'orgStudyIdInfo': {'id': '20194981'}, 'secondaryIdInfos': [{'id': 'UCI 19-16', 'type': 'OTHER', 'domain': 'UCI CFCCC'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Bupivacaine TAP Block', 'description': 'The first 15 patients enrolled will receive perioperative plain bupivacaine TAP blocks.', 'interventionNames': ['Drug: Bupivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Liposomal Bupivacaine TAP Block', 'description': 'After enrolling all 15 participants in the first arm, the next 15 patients enrolled will receive perioperative single-dose Liposomal Bupivacaine TAP blocks.', 'interventionNames': ['Drug: Liposomal bupivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Liposomal Bupivacaine TAP Block with Re-dosing', 'description': 'After enrolling all 30 patients in the first two arms, the final 15 patients enrolled will receive perioperative Liposomal Bupivacaine TAP blocks followed by redosing of the TAP blocks in 48-60 hours.', 'interventionNames': ['Drug: Liposomal bupivacaine']}], 'interventions': [{'name': 'Bupivacaine', 'type': 'DRUG', 'description': 'Participants in this group will receive a TAP block using the drug Bupivacaine.', 'armGroupLabels': ['Bupivacaine TAP Block']}, {'name': 'Liposomal bupivacaine', 'type': 'DRUG', 'description': 'Participants in this group will receive a TAP block using the drug Liposomal Bupivacaine.', 'armGroupLabels': ['Liposomal Bupivacaine TAP Block']}, {'name': 'Liposomal bupivacaine', 'type': 'DRUG', 'otherNames': ['With Re-dosing'], 'description': 'Participants in this group will receive a TAP block using the drug Liposomal Bupivacaine followed by a re-dosing during their hospitalization', 'armGroupLabels': ['Liposomal Bupivacaine TAP Block with Re-dosing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92868', 'city': 'Orange', 'state': 'California', 'country': 'United States', 'facility': 'University of California, Irvine', 'geoPoint': {'lat': 33.78779, 'lon': -117.85311}}], 'overallOfficials': [{'name': 'Jill H Tseng, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Irvine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Irvine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Jill Tseng', 'investigatorAffiliation': 'University of California, Irvine'}}}}