Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2026-03-05 @ 10:59 AM
Study NCT ID:
NCT02645903
Status:
COMPLETED
Last Update Posted:
2016-01-06
First Post:
2015-12-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transversus Abdominis Plane Block for Postoperative Analgesia in Living Donor Hepatectomy
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': 'D009020', 'term': 'Morphine'}], 'ancestors': [{'id': 'D009022', 'term': 'Morphine Derivatives'}, {'id': 'D009019', 'term': 'Morphinans'}, {'id': 'D053610', 'term': 'Opiate Alkaloids'}, {'id': 'D000470', 'term': 'Alkaloids'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D006572', 'term': 'Heterocyclic Compounds, Bridged-Ring'}, {'id': 'D006576', 'term': 'Heterocyclic Compounds, 4 or More Rings'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D010616', 'term': 'Phenanthrenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-01-05', 'studyFirstSubmitDate': '2015-12-24', 'studyFirstSubmitQcDate': '2015-12-31', 'lastUpdatePostDateStruct': {'date': '2016-01-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain scores (at movement and at rest)', 'timeFrame': 'postoperatively at 24 hours', 'description': 'Pain scores were assessed using a visual analog scale (0: No pain, 1, 2, 3, 4, 5, 6, 7, 8, 9, 10: Excruciating pain).'}], 'secondaryOutcomes': [{'measure': 'morphine consumption', 'timeFrame': 'postoperatively at 24 hours', 'description': 'morphine consumption were measured in postoperatively 24 hours'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['transversus abdominis plane block', 'living liver transplantation', 'postoperative analgesia'], 'conditions': ['Acute Pain']}, 'referencesModule': {'references': [{'pmid': '22286518', 'type': 'RESULT', 'citation': 'Abdallah FW, Chan VW, Brull R. Transversus abdominis plane block: a systematic review. Reg Anesth Pain Med. 2012 Mar-Apr;37(2):193-209. doi: 10.1097/AAP.0b013e3182429531.'}]}, 'descriptionModule': {'briefSummary': 'Living donor organ transplantation has increased in recent years due to an increased need for organs. The objective of this study was to investigate the effects of a TAP block on postoperative analgesia and opioid consumption in liver transplantation donors in whom a right lateral extending upper mid-line abdominal incision was used.', 'detailedDescription': 'This prospective randomized controlled double-blinded study was conducted with 50 liver transplantation donors between 18-65 years who were scheduled to undergo right hepatectomy surgery. Cases to whom TAP block with ultrasound was applied after standard general anesthesia were determined as Group 1 and cases to whom only standard general anesthesia was applied, were determined as Group 2.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Liver transplantation donors\n\nExclusion Criteria:\n\n* Patients with a history of allergy to the drugs used in the study protocol, coagulation pathology, opioid tolerance'}, 'identificationModule': {'nctId': 'NCT02645903', 'briefTitle': 'Transversus Abdominis Plane Block for Postoperative Analgesia in Living Donor Hepatectomy', 'organization': {'class': 'OTHER', 'fullName': 'Inonu University'}, 'officialTitle': 'Ultrasound-guided Transversus Abdominis Plane Block for Postoperative Analgesia in Living Donor Hepatectomy: Randomized Controlled Double-blinded Trial', 'orgStudyIdInfo': {'id': 'TAP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'transversus abdominis plane block', 'description': 'Patients who received a tranversus abdominis plane block with ultrasound after standard general anesthesia represented Group 1.\n\nThe tranversus abdominis plane block was performed bilaterally by obtaining an image with real time ultrasound guidance with a 6-13 MHz linear probe.\n\nThe block was placed with a 22 G 80 mm needle while obtaining real-time images via an in-plane technique.\n\nTwo 20 mL syringes were prepared after preparing a local anesthetic concentration of 1.5 mg/kg of 0.5% bupivacaine to 40 mL with saline. These were administered to the left and right abdominal walls.\n\nPostoperative analgesia was administered through a morphine the patient-controlled analgesia device.', 'interventionNames': ['Drug: Transversus Abdominis Plane Block']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'nonblocked', 'description': 'Patients who received standard general anesthesia alone made up Group 2. Postoperative analgesia was administered through a morphine the patient-controlled analgesia device.', 'interventionNames': ['Drug: standard general anesthesia']}], 'interventions': [{'name': 'Transversus Abdominis Plane Block', 'type': 'DRUG', 'otherNames': ['Marcaine plain+morphine'], 'description': 'Cases to whom used bupivacaine with ultrasound guided transversus abdominis plane block was applied after standard general anesthesia were determined as Group 1', 'armGroupLabels': ['transversus abdominis plane block']}, {'name': 'standard general anesthesia', 'type': 'DRUG', 'otherNames': ['morphine'], 'description': 'Cases to whom applied alone standard general anesthesia were determined as Group 2', 'armGroupLabels': ['nonblocked']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Mehmet Ali Erdogan', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Inonu University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inonu University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associted professor', 'investigatorFullName': 'Mehmet Ali Erdoğan', 'investigatorAffiliation': 'Inonu University'}}}}