Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2026-02-23 @ 8:07 PM
Study NCT ID:
NCT01848951
Status:
COMPLETED
Last Update Posted:
2023-11-28
First Post:
2013-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Epidural and TAP Block in Abdominal Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059787', 'term': 'Acute Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007268', 'term': 'Injections, Epidural'}, {'id': 'D000779', 'term': 'Anesthetics, Local'}], 'ancestors': [{'id': 'D007278', 'term': 'Injections, Spinal'}, {'id': 'D007267', 'term': 'Injections'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D000777', 'term': 'Anesthetics'}, {'id': 'D002492', 'term': 'Central Nervous System Depressants'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D018689', 'term': 'Sensory System Agents'}, {'id': 'D018373', 'term': 'Peripheral Nervous System Agents'}, {'id': 'D002491', 'term': 'Central Nervous System Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2016-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-22', 'studyFirstSubmitDate': '2013-04-25', 'studyFirstSubmitQcDate': '2013-05-05', 'lastUpdatePostDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pain scores', 'timeFrame': '96 hours post-op', 'description': 'Comparison of pain scores (0 = no pain to 10 = worst pain possible)'}, {'measure': 'Opioid Consumption in a 24-Hour period', 'timeFrame': '96 hours post-op', 'description': 'A comparison of opioid consumption in a 24-Hour period at 96 hours post-op between the interventions'}], 'secondaryOutcomes': [{'measure': 'Comparison of 96-hour hospital stay costs', 'timeFrame': '96 hours post-op', 'description': 'Comparison of 96-hour hospital stay cost between the interventions'}, {'measure': 'Comparison of urinary failure/catheter acquired infection rates', 'timeFrame': '96 hours post-op', 'description': 'Comparison of urinary failure/catheter acquired infection rates between the interventions'}, {'measure': 'Comparison of hypotension rates', 'timeFrame': '96 hours post-op', 'description': 'Comparison hypotension rates between the interventions'}]}, 'conditionsModule': {'conditions': ['Acute Pain', 'Surgery', 'Regional Anesthesia']}, 'descriptionModule': {'briefSummary': 'This study will compare the infiltrative transversusabdominis plane (TAP) block with liposomal bupivacaine to epidural analgesia (EA) in major abdominal surgery . The efficacy of the TAP block for abdominal surgery is well documented in literature, but there are no studies utilizing long-acting bupivacaine. The investigators believe the study will demonstrate no difference between the two in terms of pain scores and opioid consumption, but TAP blocks will decreased costs, urinary retention, and hypotension.', 'detailedDescription': 'This study intends to examine this rational by comparing the infiltrative transversusabdominis plane (TAP) block with liposomal bupivacaine to EA in major abdominal surgery. The efficacy of the TAP block for abdominal surgery is well documented in the literature, but there are no studies utilizing long-acting bupivacaine. The investigators believe the primary outcome will demonstrate no difference between the two in terms of pain scores and opioid consumption. The investigators anticipate that patients who have undergone TAP blocks will have improved secondary outcomes with respect to a decreased costs, urinary retention, and hypotension.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult subjects undergoing major abdominal surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* subject \\>/= 19 years of age\n* Undergoing major abdominal surgery\n* able to provide written informed consent\n\nExclusion Criteria:\n\n* chronic opioid use\n* allergies to amide anesthetics\n* inability to undergo general anesthesia\n* pregnancy\n* any existence of contraindications to regional anesthesia in the presence of antiplatelet or anticoagulative drugs\n* or evidence of gross neurological dysfunction of the lower extremity'}, 'identificationModule': {'nctId': 'NCT01848951', 'briefTitle': 'Comparison of Epidural and TAP Block in Abdominal Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Nebraska'}, 'officialTitle': 'Comparison of Epidural Analgesia With Bilateral Dual TAP Infiltration Block With Liposomal Bupivacaine in Patients With Major Abdominal Surgery', 'orgStudyIdInfo': {'id': '0287-13-FB'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Epidural', 'description': "The skin will be disinfected with 2% chlorhexidine. Under sterile technique, the epidural will be placed. Epidural catheter will be placed at thoracic vertebral levels T5 to T10. Level chosen as clinically indicated. The epidural solution should contain institution's standard solution of Bupivicaine 0.05% and hydromorphone 10 mcg/cc. However, solution type should be clinically indicated.", 'interventionNames': ['Drug: Epidural']}, {'label': 'TAP Block', 'description': 'The skin will be disinfected with 2% chlorhexidine. The bilateral dual TAP infiltrative blocks will be placed using high-frequency ultrasound. The TAP blocks will be performed using lipospheric bupivacaine (Exparel) with the following dosing regimen.A 266mg (20cc) vial of lipospheric bupivacaine will be equally into 2 30 ml syringes using strict sterile technique. The solution will be diluted in each syringe with 20cc preservative free sterile 0.9% normal saline to a total volume of 30 ml in each syringe. Once the transversus abdominal plane is identified then a 5-10 ml of plain 0.9% normal saline will be injected to open the fascial plane. Once the plane is opened then the 15cc of diluted lipospheric bupivacaine will be administered under direct ultrasound visualization in all 4 TAP quadrants (subcostal position x2 and lateral position x2)', 'interventionNames': ['Drug: TAP Block']}], 'interventions': [{'name': 'Epidural', 'type': 'DRUG', 'otherNames': ['local anesthetic'], 'description': "The skin will be disinfected with 2% chlorhexidine. Under sterile technique, the epidural will be placed. Epidural catheter will be placed at thoracic vertebral levels T5 to T10. Level chosen as clinically indicated. The epidural solution should contain institution's standard solution of Bupivicaine 0.05% and hydromorphone 10 mcg/cc. However, solution type should be clinically indicated.", 'armGroupLabels': ['Epidural']}, {'name': 'TAP Block', 'type': 'DRUG', 'otherNames': ['transversus abdominis plane, abdominal muscle anesthesia'], 'description': 'The skin will be disinfected with 2% chlorhexidine. The bilateral dual TAP infiltrative blocks will be placed using high-frequency ultrasound. The TAP blocks will be performed using lipospheric bupivacaine (Exparel) with the following dosing regimen.A 266mg (20cc) vial of lipospheric bupivacaine will be equally into 2 30 ml syringes using strict sterile technique. The solution will be diluted in each syringe with 20cc preservative free sterile 0.9% normal saline to a total volume of 30 ml in each syringe. Once the transversus abdominal plane is identified then a 5-10 ml of plain 0.9% normal saline will be injected to open the fascial plane. Once the plane is opened then the 15cc of diluted lipospheric bupivacaine will be administered under direct ultrasound visualization in all 4 TAP quadrants (subcostal position x2 and lateral position x2)', 'armGroupLabels': ['TAP Block']}]}, 'contactsLocationsModule': {'locations': [{'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}], 'overallOfficials': [{'name': 'Thomas A Nicholas, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Nebraska'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Nebraska', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}