Ignite Creation Date:
2025-12-24 @ 2:50 PM
Ignite Modification Date:
2026-02-18 @ 12:51 PM
Study NCT ID:
NCT06566859
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-22
First Post:
2024-08-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of ESP Block and M-TAPA Block Efficiency in Postoperative Analgesia Management in Nephrectomy Cases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010149', 'term': 'Pain, Postoperative'}, {'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D011183', 'term': 'Postoperative Complications'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-20', 'studyFirstSubmitDate': '2024-08-11', 'studyFirstSubmitQcDate': '2024-08-20', 'lastUpdatePostDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postoperative Pain Management', 'timeFrame': '0.hour', 'description': 'The primary outcome of this study is to demonstrate that Modified Thoracoabdominal Nerves Block(M-TAPA) contributes sufficiently to multimodal analgesia in perioperative analgesia in nephrectomy surgery.This contribution will be evaluated with the NRS. NRS is a unidimensional scale in which 11 numbers (between 0 and 10) are used to measure pain intensity. The patient is asked to choose the number that best reflects the pain intensity, with 0 = no pain and 10 = worst (unbearable) pain.'}, {'measure': 'Postoperative Pain Management', 'timeFrame': '6.hour', 'description': 'The primary outcome of this study is to demonstrate that Modified Thoracoabdominal Nerves Block(M-TAPA) contributes sufficiently to multimodal analgesia in perioperative analgesia in nephrectomy surgery.This contribution will be evaluated with the NRS. NRS is a unidimensional scale in which 11 numbers (between 0 and 10) are used to measure pain intensity. The patient is asked to choose the number that best reflects the pain intensity, with 0 = no pain and 10 = worst (unbearable) pain.'}, {'measure': 'Postoperative Pain Management', 'timeFrame': '12.hour', 'description': 'The primary outcome of this study is to demonstrate that Modified Thoracoabdominal Nerves Block(M-TAPA) contributes sufficiently to multimodal analgesia in perioperative analgesia in nephrectomy surgery.This contribution will be evaluated with the NRS. NRS is a unidimensional scale in which 11 numbers (between 0 and 10) are used to measure pain intensity. The patient is asked to choose the number that best reflects the pain intensity, with 0 = no pain and 10 = worst (unbearable) pain.'}, {'measure': 'Postoperative Pain Management', 'timeFrame': '24.hour', 'description': 'The primary outcome of this study is to demonstrate that Modified Thoracoabdominal Nerves Block(M-TAPA) contributes sufficiently to multimodal analgesia in perioperative analgesia in nephrectomy surgery.This contribution will be evaluated with the NRS. NRS is a unidimensional scale in which 11 numbers (between 0 and 10) are used to measure pain intensity. The patient is asked to choose the number that best reflects the pain intensity, with 0 = no pain and 10 = worst (unbearable) pain.'}, {'measure': 'Postoperative Pain Management', 'timeFrame': '24 hours', 'description': 'Total amount of analgesic used in 24 hours'}, {'measure': 'Postoperative Pain Management', 'timeFrame': '24 hours', 'description': 'Time of first additional analgesic requirement up to 24 hours'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nerve block', 'pain management', 'postoperative period', 'postoperative complications', 'regional anesthesia', 'pain'], 'conditions': ['Pain, Postoperative']}, 'descriptionModule': {'briefSummary': 'Relieving postoperative nephrectomy pain requires multimodal approaches. Peripheral blocks such as ESP block and M-TAPA block and multimodal analgesics reduce side effects by reducing the use of other analgesics. This study aimed to compare the effectiveness of erector spinae plane block (ESP block) and modified thoracoabdominal nerve blocking with perichondrial approach (M-TAPA block) in postoperative analgesia management in nephrectomy cases.', 'detailedDescription': 'Relieving postoperative nephrectomy pain requires multimodal approaches. The most commonly used in the treatment of pain are nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, and infiltration of local anesthetics. Due to the side effects of NSAIDs and opioids, the application of regional analgesia techniques can reduce complications while providing better analgesia quality. Peripheral blocks such as ESP block and M-TAPA block and multimodal analgesics reduce side effects by reducing the use of other analgesics. Pain is considered one of the most important factors affecting the quality of healing. Postoperative pain delays the postanesthesia care unit, hospital stay, early ambulation, increases resource utilization, and negatively affects patient satisfaction. If postoperative analgesia is provided, all these negativities will be eliminated. This study aimed to compare the effectiveness of erector spinae plane block (ESP block) and modified thoracoabdominal nerve blocking with perichondrial approach (M-TAPA block) in postoperative analgesia management in nephrectomy cases.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All patients aged 18 and over with ASA1-2 who underwent elective nephrectomy.\n\n.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients aged 18 and over with ASA1-2 who underwent elective nephrectomy\n\nExclusion Criteria:\n\n* ASA ≥3\n* Body mass index\\>35 kg/ m²\n* Infection in the block area\n* Coagulation disorder,\n* Known allergy to local anesthetics\n* Pregnant\n* Patient with neuropathy\n* Patient without cooperation\n* Patient who refuses to participate in the study\n* Patients under 18 years of age'}, 'identificationModule': {'nctId': 'NCT06566859', 'briefTitle': 'Comparison of ESP Block and M-TAPA Block Efficiency in Postoperative Analgesia Management in Nephrectomy Cases', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Başakşehir Çam & Sakura City Hospital'}, 'officialTitle': 'Comparison of ESP Block and M-TAPA Block Efficiency in Postoperative Analgesia Management in Nephrectomy Cases', 'orgStudyIdInfo': {'id': '2024-297'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'M-TAPA Block', 'description': 'Patients who have standard anesthesia are randomized with the research randomizer application while under anesthesia and M-TAPA block is applied under ultrasound guidance in the preoperative period. For the block, 50 mg of 0.25% bupivacaine and 100 mg lidocaine are injected, totaling 20cc.', 'interventionNames': ['Other: NRS 0. hour', 'Other: NRS 6. Hour', 'Other: NRS 12. Hour', 'Other: NRS 24. Hour']}, {'label': 'ESP Block', 'description': 'Patients who have standard anesthesia are randomized with the research randomizer application while under anesthesia and ESP block is applied under ultrasound guidance in the preoperative period. For the block, 50 mg of 0.25% bupivacaine and 100 mg lidocaine are injected, totaling 20cc.', 'interventionNames': ['Other: NRS 0. hour', 'Other: NRS 6. Hour', 'Other: NRS 12. Hour', 'Other: NRS 24. Hour']}], 'interventions': [{'name': 'NRS 0. hour', 'type': 'OTHER', 'description': 'Numerical rating scala', 'armGroupLabels': ['ESP Block', 'M-TAPA Block']}, {'name': 'NRS 6. Hour', 'type': 'OTHER', 'description': 'Numerical rating scala', 'armGroupLabels': ['ESP Block', 'M-TAPA Block']}, {'name': 'NRS 12. Hour', 'type': 'OTHER', 'description': 'Numerical rating scala', 'armGroupLabels': ['ESP Block', 'M-TAPA Block']}, {'name': 'NRS 24. Hour', 'type': 'OTHER', 'description': 'Numerical rating scala', 'armGroupLabels': ['ESP Block', 'M-TAPA Block']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'BasaksehirCamSakuraH', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}], 'centralContacts': [{'name': 'Hilal Akça', 'role': 'CONTACT', 'email': 'drhllbs@gmail.com', 'phone': '05548421509'}], 'overallOfficials': [{'name': 'Hilal Akça', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'BasaksehirCamSakuraH'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Başakşehir Çam & Sakura City Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Hilal AKCA', 'investigatorAffiliation': 'Başakşehir Çam & Sakura City Hospital'}}}}