Ignite Creation Date:
2025-12-24 @ 9:22 PM
Ignite Modification Date:
2025-12-30 @ 1:26 AM
Study NCT ID:
NCT06995404
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-29
First Post:
2025-04-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Transversus Abdominis Plane Block (TAP) Versus Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) in Laparoscopic Gynecologic Surgeries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-26', 'studyFirstSubmitDate': '2025-04-28', 'studyFirstSubmitQcDate': '2025-05-26', 'lastUpdatePostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of intraoperative opioid consumption', 'timeFrame': 'during surgery'}], 'secondaryOutcomes': [{'measure': 'Comparison of postoperative Visual Analog Scale (VAS) pain scores', 'timeFrame': 'postoperative first day', 'description': 'VAS is an eleven-scale pain score scored from 0 to 10, with vas 0 being no pain and vas 10 being maximum pain.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Gynecologic Laparoscopic Surgery', 'Regional Anesthesia Block']}, 'descriptionModule': {'briefSummary': 'Although laparoscopic techniques are considered minimally invasive surgical procedures with lower perioperative pain scores compared to open surgeries, they are still associated with significant levels of pain. This study aims to investigate the analgesic effectiveness of two routinely performed regional analgesic techniques in our clinic-ultrasound-guided classic bilateral TAP block and ultrasound-guided bilateral M-TAPA block-in patients undergoing laparoscopic gyneco-oncologic surgery (LGOS), as well as their effects on intraoperative opioid consumption.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'female', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:Female patients aged between 18 and 80 years, classified as ASA physical status I to III, undergoing laparoscopic gynecologic surgery under general anesthesia -\n\nExclusion Criteria:Coagulopathy\n\nNeuropathy\n\nChronic analgesic therapy\n\nSevere cardiopulmonary disease\n\nUncontrolled diabetes mellitus (HbA1c \\> 8%)\n\nSevere renal or hepatic failure\n\nPregnancy or lactation\n\nBody mass index (BMI) greater than 35 kg/m²\n\nLocal infection at the injection site\n\nInability to comprehend pain scores or cooperate (e.g., Alzheimer's disease, mental retardation)\n\nAllergy to local anesthetic agents\n\nRefusal to participate in the study\n\n\\-"}, 'identificationModule': {'nctId': 'NCT06995404', 'briefTitle': 'Transversus Abdominis Plane Block (TAP) Versus Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) in Laparoscopic Gynecologic Surgeries', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ankara Etlik City Hospital'}, 'officialTitle': 'Transversus Abdominis Plane Block (TAP) Versus Thoracoabdominal Nerve Block Through Perichondrial Approach (M-TAPA) in Laparoscopic Gynecologic Surgeries', 'orgStudyIdInfo': {'id': 'AESH-EK-2025-028'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'control'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group TAP', 'interventionNames': ['Procedure: TAP Block Group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'group M-TAPA', 'interventionNames': ['Procedure: M-TAPA Block group']}], 'interventions': [{'name': 'TAP Block Group', 'type': 'PROCEDURE', 'description': 'Patients in the TAP group will receive a bilateral Transversus Abdominis Plane (TAP) block under ultrasound guidance prior to surgery after general anaesthesia, with the local anesthetic administered between the internal oblique and transversus abdominis muscles. A total of 40 mL of 0.25% bupivacaine will be used for the procedure.', 'armGroupLabels': ['group TAP']}, {'name': 'M-TAPA Block group', 'type': 'PROCEDURE', 'description': 'Patients in the M-TAPA group will receive a bilateral Thoracoabdominal Nerve Block through Perichondrial Approach (M-TAPA) under ultrasound guidance prior to surgery after general anaesthesia. A total of 40 mL of 0.25% bupivacaine will be used for the procedure.', 'armGroupLabels': ['group M-TAPA']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06010', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'ela erdem hıdıroglu', 'role': 'CONTACT', 'email': 'drelaerdem@gmail.com', 'phone': '+905348874184'}], 'facility': 'Ankara Etlik City Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}], 'centralContacts': [{'name': 'ELA ERDEM HIDIROGLU', 'role': 'CONTACT', 'email': 'drelaerdem@gmail.com', 'phone': '03127970000'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ankara Etlik City Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Ela Erdem Hıdiroglu', 'investigatorAffiliation': 'Ankara Etlik City Hospital'}}}}