Ignite Creation Date:
2025-12-24 @ 8:00 PM
Ignite Modification Date:
2026-01-05 @ 6:08 PM
Study NCT ID:
NCT03737604
Status:
RECRUITING
Last Update Posted:
2025-03-27
First Post:
2018-10-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TAP Blocks With Ropivacaine Continuous Infusion Catheters vs Single Dose Liposomal Bupivicaine After Kidney Transplant
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Unable to mask based on physical characteristics of liposomal bupivacaine'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-10-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-06-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-26', 'studyFirstSubmitDate': '2018-10-09', 'studyFirstSubmitQcDate': '2018-11-07', 'lastUpdatePostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difference in Total Opioid Consumption', 'timeFrame': 'Through 4 days following renal transplant surgery', 'description': 'Total amount of opioid analgesic administered following renal transplant surgery converted using standard equivalency calculations to morphine equivalents mg/kg'}], 'secondaryOutcomes': [{'measure': 'Proportion of pain scores indicating severe pain', 'timeFrame': 'Through 4 days following renal transplant surgery', 'description': 'Proportion of pain scores 7 or higher indicating severe pain as determined by patient report of pain using verbal pain score from 0 (no pain) to10 (most severe pain)'}, {'measure': 'Post Operative Nausea', 'timeFrame': 'Through 4 days following renal transplant surgery', 'description': 'Count of post operative nausea episodes'}, {'measure': 'Post Operative Vomiting', 'timeFrame': 'Through 4 days following renal transplant', 'description': 'Count of post operative vomiting events'}, {'measure': 'Respiratory Depression', 'timeFrame': 'Through 4 days following renal transplant surgery', 'description': 'Count of Respiratory Depression events defined as respiratory rate less than 8 breaths per minute'}, {'measure': 'Post Operative Care Unit and Hospital Length of Stay', 'timeFrame': 'Up to 2 weeks following renal transplant surgery', 'description': 'Length of Stay'}, {'measure': 'Acquisition Costs Related to Analgesia', 'timeFrame': 'Up to 2 weeks following renal transplant surgery', 'description': 'Analgesia Related Costs defined as the sum of hospital specific costs to acquire medications and supplies needed to perform block or administer analgesic and local anesthetic medications'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Transversus Abdominis Plane Block', 'Ropivacaine', 'Liposomal bupivacaine'], 'conditions': ['Transplant;Failure,Kidney', 'Pain, Postoperative']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://studypages.com/s/a-study-of-the-experimental-medicine-ropivacaine-for-pain-control-after-kidney-transplant-995191/', 'label': 'Learn more or sign up for the study here!'}]}, 'descriptionModule': {'briefSummary': 'This study is a comparison of the analgesic efficacy of transversus abdominis plane (TAP) blocks with ropivacaine bolus plus continuous ropivacaine infusion via catheters versus single shot TAP blocks with liposomal bupivacaine.', 'detailedDescription': 'This study is a comparison of the analgesic efficacy of TAP blocks provided by ropivacaine bolus plus continuous ropivacaine infusion via catheters versus single shot TAP blocks with liposomal bupivacaine.\n\nIn the Liposomal Bupivacaine group, TAP block will be performed using ultrasound guidance. 12ml of 0,25% plain bupivacaine will be used for skin infiltration and to open up the TAP. Liposomal Bupivacaine 266 mg (1.3% in 20 ml) will be diluted to 40 ml volume with 20 ml of preservative free normal saline. 20 ml (133mg) of liposomal bupivicaine will then be injected into the TAP.\n\nFor those randomized to the TAP catheter group, ultrasound guidance will be used for TAP block and 5 mls 1% lidocaine will be used for skin infiltration. A peripheral nerve catheter will be placed approximately 3-5 cm into the TAP space after injection of ropivacaine. A bolus dose of 2.5 mg/kg of ropivacaine will be administered in a volume of 30 ml up to a maximum of 150 mg. An infusion with a programmable pump will be initiated at a rate of 8 ml/hr of 0.2% ropivacaine on the inpatient floor.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients ages 18 years or older\n* Renal Transplant Recipients\n\nExclusion Criteria:\n\n* Patients less than 18 years of age\n* Pregnant Women\n* Prisoners\n* Opioid Tolerant Patients taking more than 30 mg/day of oral morphine equivalent analgesia\n* Patients on Systemic anti coagulation\n* Patients unable to provide consent\n* Hypersensitivity to amide-type local anesthetic or any component of the drug formula'}, 'identificationModule': {'nctId': 'NCT03737604', 'briefTitle': 'TAP Blocks With Ropivacaine Continuous Infusion Catheters vs Single Dose Liposomal Bupivicaine After Kidney Transplant', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'Transversus Abdominis Plane (TAP) Blocks With Ropivacaine Continuous Infusion Catheters vs Single Dose Liposomal Bupivicaine: A Prospective Randomized Control Trial for Pain Control After Renal Transplant Surgery', 'orgStudyIdInfo': {'id': '1205738'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Ropivacaine Continuous Infusion Catheter', 'description': 'Ropivacaine Continuous Infusion Catheter: ultrasound guided TAP block and TAP catheter placement performed with 0.2% ropivacaine (2.5 mg/kg) and maintained with 0.2% ropivacaine infusion 8 ml/hour via catheter.', 'interventionNames': ['Drug: Ropivacaine Continuous Infusion Catheter']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Single dose liposomal bupivicaine', 'description': 'Liposomal bupivacaine TAP block: ultrasound guided TAP block a performed with up to 12 ml 0.25% bupivacaine and prolonged with liposomal bupivacaine 133 mg diluted to total volume of 20 ml with preservative free saline.', 'interventionNames': ['Drug: Single Dose Liposomal Bupivicaine']}], 'interventions': [{'name': 'Ropivacaine Continuous Infusion Catheter', 'type': 'DRUG', 'otherNames': ['TAP block initiated with ropivacaine bolus and infusion'], 'description': 'For those randomized to the TAP catheter group, ultrasound guidance will be used for TAP block and 5mls 1% lidocaine will be used for skin infiltration. A peripheral nerve catheter will be placed approximately 3-5 cm into the TAP space after injection of the ropivacaine solution. A bolus dose of 2.5 mg/kg of ropivacaine will be administered in a volume of 30 ml up to a maximum of 150 mg. An infusion with a programmable pump will be initiated at a rate of 8 ml/hr of 0.2% ropivacaine on the inpatient floor.', 'armGroupLabels': ['Ropivacaine Continuous Infusion Catheter']}, {'name': 'Single Dose Liposomal Bupivicaine', 'type': 'DRUG', 'otherNames': ['TAP block with liposomal bupivacaine'], 'description': 'TAP block will be performed using ultrasound guidance. 12ml of 0,25% plain bupivacaine will be used for skin infiltration and to open up the TAP. Liposomal bupivacaine 266 mg (1.3% in 20 ml) will be diluted to 40 ml volume with 20 ml of preservative free normal saline. 20 ml (133mg) of liposomal bupivicaine will then be injected into the TAP.', 'armGroupLabels': ['Single dose liposomal bupivicaine']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ana Arias, BS', 'role': 'CONTACT', 'email': 'apaarias@ucdavis.edu', 'phone': '916-703-5456'}, {'name': 'Natasha Piniero, BS', 'role': 'CONTACT', 'email': 'nspiniero@ucdavis.edu', 'phone': '916-734-5171'}, {'name': 'Richard Applegate, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of California Davis', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}], 'centralContacts': [{'name': 'Ana Arias, BS', 'role': 'CONTACT', 'email': 'apaarias@ucdavis.edu', 'phone': '916-703-5456'}, {'name': 'Natasha Piniero, BS', 'role': 'CONTACT', 'email': 'nspiniero@ucdavis.edu', 'phone': '916-734-5171'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}