Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:51 AM
Study NCT ID:
NCT07311902
Status:
RECRUITING
Last Update Posted:
2025-12-31
First Post:
2025-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
M-Tapa Block and Transversus Abdominal Plane Block for Postoperative Analgesia in Unilateral Open Inguinal Hernia Repair Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-01-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-30', 'studyFirstSubmitDate': '2025-06-18', 'studyFirstSubmitQcDate': '2025-12-30', 'lastUpdatePostDateStruct': {'date': '2025-12-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-12-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'pain score', 'timeFrame': 'The primary aim of our study was to compare VAS scores at 1, 2, 4, 8, 12, and 24 hours postoperatively and to evaluate the level of comfort.', 'description': "Patients' pain scores will be evaluated"}], 'secondaryOutcomes': [{'measure': 'The QoR-15 Patient Questionnaire, a 40-question global recovery rating system with a Turkish variant', 'timeFrame': '24 hours following surgery.', 'description': 'To compare patient satisfaction survey and pain monitoring in patients who underwent M-Tapa Block and Transversus Abdominal Plane block for postoperative analgesia in unilateral open inguinal hernia repair surgery and to suggest a more effective method.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain Management', 'Mtapa Block', 'TAP Block']}, 'descriptionModule': {'briefSummary': 'Patients will be called to the operating room one hour before surgery and no premedication will be applied before coming to the operating room. Patients in both groups who are taken to the block room will be administered 1-2 mg iv midazolam for sedation. M TAPA block will be applied for the surgical procedure. After aseptic conditions are provided, the high-frequency linear US probe will be covered with a sterile sheath. The US probe will be placed in the saggital plane at the costochondral angle where the midclavicular line intersects the costal cartilage. 5 ml of saline will be injected using the in-plane technique using a 22G 100 mm block needle and the block location will be verified. After the block location is verified, a total of 20 ml of 0.25% bupivacaine will be injected unilaterally and the procedure will be terminated. After aseptic conditions are provided, the high-frequency linear US probe will be covered with a sterile sheath. In TAP block, the block needle will be advanced to the fascial plane between the internal oblique and transversus abdominis muscles with the in-plane technique and the procedure will be completed by injecting 5 ml 20 ml 0.25% bupivacaine unilaterally. The same analgesia protocol will be applied to both groups intraoperatively and postoperatively, and a survey will be conducted on the patients at the 24th hour postoperatively.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Exclusion Criteria:\n\n* History of bleeding diathesis\n* Allergy or sensitivity to local anesthetics and opioids\n* Infection in the area where the block will be applied\n* Alcohol or drug addiction\n* Patients with a BMI \\> 30\n* Suspected pregnancy\n* Women in pregnancy or lactation\n* Patients with allergies to study drugs\n* Patient refusal\n* Use of anticoagulant agents\n\nInclusion Criteria:\n\n* Planning for elective unilateral open inguinal hernia repair surgery\n* ASA I-II status\n* Being between 18 and 65 years of age'}, 'identificationModule': {'nctId': 'NCT07311902', 'acronym': 'pain', 'briefTitle': 'M-Tapa Block and Transversus Abdominal Plane Block for Postoperative Analgesia in Unilateral Open Inguinal Hernia Repair Surgery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Erzurum Regional Training & Research Hospital'}, 'officialTitle': 'Comparison of Patient Satisfaction Survey and Pain Follow-up in Patients Who Underwent M-Tapa Block and Transversus Abdominal Plane Block for Postoperative Analgesia in Unilateral Open Inguinal Hernia Repair Surgery', 'orgStudyIdInfo': {'id': 'B.30.2.YYU.0.01.00.00/93'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group T', 'description': 'The block needle will be advanced to the fascial plane between the internal oblique and transversus abdominis muscles by placing the USG transversely on the mid-axillary line between the iliac crest and subcostal planes. 5 ml saline will be injected and the block location will be confirmed. After the block location is confirmed, a total of 20 ml of 0.25% bupivacaine will be injected unilaterally and the procedure will be completed.', 'interventionNames': ['Procedure: TAP Block Group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group M', 'description': 'Using the in-plane technique, the probe will be pushed slightly to visualize the lower part of the costochondral angle at the central level, the block needle will be advanced in the caudal-cranio direction, 5 ml of saline will be injected into the layer between the transverse abdominal muscle and the lower plane of the costal cartilage via a 22G 100 mm block needle and the block location will be confirmed. After the block location is confirmed, a total of 20 ml of 0.25% bupivacaine will be injected unilaterally and the procedure will be completed.', 'interventionNames': ['Procedure: M TAPA block']}], 'interventions': [{'name': 'TAP Block Group', 'type': 'PROCEDURE', 'description': '20 ml of 0.25% bupivacaine', 'armGroupLabels': ['Group T']}, {'name': 'M TAPA block', 'type': 'PROCEDURE', 'description': '20 ml of 0.25% bupivacaine', 'armGroupLabels': ['Group M']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25000', 'city': 'Erzurum', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Erzurum RTRH', 'role': 'CONTACT', 'email': 'erzurumsh@saglik.gov.tr', 'phone': '+90 ( 442 ) 432 10 00'}], 'facility': 'Erzurum Regional Education and Research Hospital', 'geoPoint': {'lat': 39.90861, 'lon': 41.27694}}], 'centralContacts': [{'name': 'omer doymus', 'role': 'CONTACT', 'email': 'omerdoymus@hotmail.com', 'phone': '+905070370397'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erzurum Regional Training & Research Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'Omer Doymus', 'investigatorAffiliation': 'Erzurum Regional Training & Research Hospital'}}}}