Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-31 @ 11:03 AM
Study NCT ID:
NCT05188794
Status:
COMPLETED
Last Update Posted:
2024-04-05
First Post:
2021-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Two Different Approach TAP Block on Pain Management of Laparoscopic Nephrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D010149', 'term': 'Pain, Postoperative'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D010146', 'term': 'Pain'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 88}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2022-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-04', 'studyFirstSubmitDate': '2021-11-22', 'studyFirstSubmitQcDate': '2021-12-27', 'lastUpdatePostDateStruct': {'date': '2024-04-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual analog pain scale 0', 'timeFrame': 'at the PACU arrival', 'description': 'Patients will be asked about the severity of pain. They will be told that 0 = no pain, 10 = severe pain, and they will be asked to determine a number between 0 and 10 for the severity of pain.'}, {'measure': 'Visual analog pain scale 1', 'timeFrame': 'Postoperative first hour', 'description': 'Patients will be asked about the severity of pain. They will be told that 0 = no pain, 10 = severe pain, and they will be asked to determine a number between 0 and 10 for the severity of pain.'}, {'measure': 'Visual Analog Pain scale 2', 'timeFrame': 'Postoperative second hour', 'description': 'Patients will be asked about the severity of pain. They will be told that 0 = no pain, 10 = severe pain, and they will be asked to determine a number between 0 and 10 for the severity of pain.'}, {'measure': 'Visual analog pain scale 6', 'timeFrame': 'Postoperative sixth hour', 'description': 'Patients will be asked about the severity of pain. They will be told that 0 = no pain, 10 = severe pain, and they will be asked to determine a number between 0 and 10 for the severity of pain.'}, {'measure': 'Visual Analog Pain scale 12', 'timeFrame': 'Postoperative 12. hour', 'description': 'Patients will be asked about the severity of pain. They will be told that 0 = no pain, 10 = severe pain, and they will be asked to determine a number between 0 and 10 for the severity of pain.'}, {'measure': 'Visual Analog Pain scale 18', 'timeFrame': 'Postoperative18. hour', 'description': 'Patients will be asked about the severity of pain. They will be told that 0 = no pain, 10 = severe pain, and they will be asked to determine a number between 0 and 10 for the severity of pain.'}, {'measure': 'Visual Analog Pain scale 24', 'timeFrame': 'Postoperative 24. hour', 'description': 'Patients will be asked about the severity of pain. They will be told that 0 = no pain, 10 = severe pain, and they will be asked to determine a number between 0 and 10 for the severity of pain.'}, {'measure': 'opioid comsuption', 'timeFrame': 'Within 24 hours postoperatively', 'description': 'Patients will be asked about the severity of pain. They will be told that 0 = no pain, 10 = severe pain, and they will be asked to determine a number between 0 and 10 for the severity of pain.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Analgesia, Patient-Controlled', 'Postoperative Pain, Acute']}, 'descriptionModule': {'briefSummary': 'Primary aim is to compare the effectiveness of the posterior approach Transversus abdominis plane block (P-TAP) and the lateral approach Transversus abdominis plane block (L-TAP) technique on the pain management of the laparoscopic nephrectomy in terms of visual analog pain scale and postoperative opioid consumption. Secondary aim is to compare complication rates of the two techniques.', 'detailedDescription': 'Patients included in the study will be randomized into two groups (group L and group P) in the preoperative period. Following routine anesthesia induction TAP block will be applied to group L patients with the lateral approach technique, and to group P patients with the posterior approach technique. Regional block complications will be recorded.\n\nStandard laparoscopic nephrectomy surgical method will be applied. 1g of paracetamol and 4mg of dansetron will be administered to both groups 15 minutes before the end of the operation. The pain intensity of the patients will be questioned and VAS values will be recorded at 0, 1, 2, 6, 12 and 24 hours postoperatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASAI-III patients undergoing laparoscopic nephrectomy\n* 18\\<BMI\\<40\n\nExclusion Criteria:\n\n* infection at the block site\n* coagulation disorder\n* pregnancy\n* kidney failure\n* liver failure\n* heart failure\n* allergy to local anesthetics\n* patient refusal'}, 'identificationModule': {'nctId': 'NCT05188794', 'briefTitle': 'Comparison of Two Different Approach TAP Block on Pain Management of Laparoscopic Nephrectomy', 'organization': {'class': 'OTHER', 'fullName': 'Ankara City Hospital Bilkent'}, 'officialTitle': 'Comparison of Two Different Approach Ultrasound Guided TAP Block on Pain Management of Laparoscopic Nephrectomy: Posterior or Lateral Approach?', 'orgStudyIdInfo': {'id': 'E1-21-1814'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'group L', 'description': 'Lateral transversus abdominis plane(TAP) block', 'interventionNames': ['Procedure: lateral tap block']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group P', 'description': 'Posterior transversus abdominis plane block', 'interventionNames': ['Procedure: posterior tap block']}], 'interventions': [{'name': 'lateral tap block', 'type': 'PROCEDURE', 'description': 'In the axial plane on the midaxillary line between the subcostal margin and the iliac crest with a linear probe using a 12 cm insulated nerve block needle is advanced in planely from skin, external, and internal oblique muscles to the target of fascial plane between the internal oblique and the transversus abdominis muscles.', 'armGroupLabels': ['group L']}, {'name': 'posterior tap block', 'type': 'PROCEDURE', 'description': 'In the axial plane on the midaxillary line a linear probe using a 12 cm insulated nerve block needle is advanced posteriorly to the most posterior limit of the TAP between the internal oblique and transversus abdominis muscles.', 'armGroupLabels': ['Group P']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ankara', 'state': 'Cankay', 'country': 'Turkey (Türkiye)', 'facility': 'Ankara City Hospital,Bilkent', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'overallOfficials': [{'name': 'MİYASE SERAP DİKER, DOCTOR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ANKARA CİTY HOSPİTAL'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara City Hospital Bilkent', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anaestesia and Reanimation Specialist', 'investigatorFullName': 'Serap Diker', 'investigatorAffiliation': 'Ankara City Hospital Bilkent'}}}}