Ignite Creation Date:
2025-12-25 @ 1:59 AM
Ignite Modification Date:
2025-12-26 @ 12:23 AM
Study NCT ID:
NCT04294394
Status:
COMPLETED
Last Update Posted:
2021-02-03
First Post:
2020-03-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Rhomboid Block,erectör Spiane Block, Thoracotomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-31', 'studyFirstSubmitDate': '2020-03-01', 'studyFirstSubmitQcDate': '2020-03-01', 'lastUpdatePostDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'rhomboid block versus erector spinae block in thorachotomy', 'timeFrame': 'the study will comlete in three month', 'description': 'In this study, we aimed to compare the effects of rhomboid block and erector spinae block in pain control after thoracotomy'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['rhomboid block', 'erectör spinae block'], 'conditions': ['Anesthesia']}, 'descriptionModule': {'briefSummary': 'Effective analgesia is very important in terms of preventing respiratory, thromboembolic complications and providing early mobilization after open thoracotomy.\n\nAlthough thoracic epidural analgesia is gold standart method for this aim, it causes common side effects such as hypotension, dural puncture,motor block In recent years, with the effective use of ultrasonography, different regional anesthesia methods have been developed to prevent such complications', 'detailedDescription': 'A total of 75 patients will be included in the study in three groups: group ESPB, group RIB and control group (group K). Under general anesthesia, patients who will undergo both ESPB and RIB will be applied block with a 22 G and 100 mm block needle, accompanied by ultrasonography, and 20 ml 0.25% bupivacaine. Apart from the standard peroperative analgesia protocol applied to all three groups, no additional procedure will be performed in group control. Postoperative analgesic consumption amount, first analgesic requirement time and visual analog scale (VAS) values of the patients will be recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '18 to 75 years old patients will including in this study. Patients Asa Scores shold be ASA1,2,3', 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients between 18-75 years old\n* ASA1,2,3 group patients\n* Patients undergoing thoracotomy under general anesthesia\n\nExclusion Criteria:\n\n* The patient's refusal to participate in the study\n* Allergy to local anesthetics"}, 'identificationModule': {'nctId': 'NCT04294394', 'briefTitle': 'Rhomboid Block,erectör Spiane Block, Thoracotomy', 'organization': {'class': 'OTHER', 'fullName': 'Kocaeli Derince Education and Research Hospital'}, 'officialTitle': 'Rhomboid Block Versus Erector Spinae Block in Thoracotomy', 'orgStudyIdInfo': {'id': '2019/514/150/22'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'rhomboid block', 'description': 'With a 6-13 Mhz linear USG probe, at the thoracal level of 6-7 vertebra in the sagittal position, in the cranio-caudal direction with a 22 G and 100 mm block needle in the medial of the scapula, after entering the facial plane between the rhomboid muscle and the intercostal muscle, 0.25% bupivacaine 20 ml of the local anesthetic solution will be given.', 'interventionNames': ['Other: rhomboid block']}, {'label': 'erector spinae group', 'description': 'After the patient is taken in the lateral position, the probe T5 is 3 cm lateral to the spinous process, 22 G and 100 mm block needle with 6-13 Mhz linear ultrasonography and the facial plane between the transverse proces and the erector spina muscle is entered, and 20 ml of a local anesthetic solution consisting of 0.25% bupivacaine will be given.', 'interventionNames': ['Other: erector spinae block']}, {'label': 'control group', 'description': 'For postoperative analgesia, all patients (including Rhomboid block and Erector spinae block) will be administered 100 mg tramadol and 1 gr paracetamol. No additional intervention other than this medical approach will be applied in the control group.', 'interventionNames': ['Other: control']}], 'interventions': [{'name': 'rhomboid block', 'type': 'OTHER', 'description': 'Rhombid block, on the other hand, is a method which make up analgesia by providing lokal anestethetic enjection between intercostal muscles and rhomboid muscles and blocks between t3- t9 levels', 'armGroupLabels': ['rhomboid block']}, {'name': 'erector spinae block', 'type': 'OTHER', 'description': 'The Erector spinae plan block is a recently developed regional block method .Adminestering of lokal anesthetic between the transver proces and erector spinae muscles provides the dorsal and ventral branch blokades of regional spinal nerve and make up the analgesia.İt have a wide range usage such as surgery of thoracal and abdominal area', 'armGroupLabels': ['erector spinae group']}, {'name': 'control', 'type': 'OTHER', 'description': 'For postoperative analgesia, all patients (including Rhomboid block and Erector spinae block) will be administered 100 mg tramadol and 1 gr paracetamol. No additional intervention other than this medical approach will be applied in the control group.', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '41000', 'city': 'Kocaeli', 'state': 'Derince', 'country': 'Turkey (Türkiye)', 'facility': 'Derince Eğitim Ve Araştırma Hastanesi', 'geoPoint': {'lat': 39.62497, 'lon': 27.51145}}, {'zip': '34000', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Tahsin Şimşek', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kocaeli Derince Education and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'medical doctor', 'investigatorFullName': 'Tahsin Şimşek', 'investigatorAffiliation': 'Kocaeli Derince Education and Research Hospital'}}}}